Trial · NCT00934089
A Phase 2 Study Of The 24-Hour Intraocular Pressure Lowering And Systemic Exposure Of PF-04217329
NCT00934089, Phase 2, Completed, Pfizer; results first posted 2021-05-03
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ConductScience Library. A Phase 2 Study Of The 24-Hour Intraocular Pressure Lowering And Systemic Exposure Of PF-04217329. Trials, record NCT00934089. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00934089
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2 Study Of The 24-Hour Intraocular Pressure Lowering And Systemic Exposure Of PF-04217329
- NCT number
- NCT00934089
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 31 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Interventions
- PF-04217329, latanoprost vehicle, PF-04217329, latanoprost
- First posted
- 2009-07-08
- Last updated
- 2021-05-03
- Results first posted
- 2021-05-03
Source ClinicalTrials.gov
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 8 Ante Meridiem (AM) (0 Hour) | 8 AM on Baseline (Day -8), 8 AM on Day 14 (0 Hour) | IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 8 AM on Day -8 as baseline for 8 AM value on Day 14. |
| Primary | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 10 AM (2 Hours) | 10 AM on Baseline (Day -8), 10 AM on Day 14 (2 Hours) | IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury, mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 10 AM on Day -8 as baseline for 10 AM value on Day 14. |
| Primary | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 12 Post Meridiem (PM) (4 Hours) | 12 PM on Baseline (Day -8), 12 PM on Day 14 (4 Hours) | IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of 2 readings was recorded as IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 12 PM on Day -8 as baseline for 12 PM value on Day 14. |
| Primary | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 2 PM (6 Hours) | 2 PM on Baseline (Day -8), 2 PM on Day 14 (6 Hours) | IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 2 PM on Day -8 as baseline for 2 PM value on Day 14. |
| Primary | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 4 PM (8 Hours) | 4 PM on Baseline (Day -8), 4 PM on Day 14 (8 Hours) | IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 4 PM on Day -8 as baseline for 4 PM value on Day 14. |
| Primary | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 6 PM (10 Hours) | 6 PM on Baseline (Day -8), 6 PM on Day 14 (10 Hours) | IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 6 PM on Day -8 as baseline for 6 PM value on Day 14. |
| Primary | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 8 PM (12 Hours) | 8 PM on Baseline (Day -8), 8 PM on Day 14 (12 Hours) | IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit. IOP was measured in both the eyes, and eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 8 PM on Day -8 as baseline for 8 PM value on Day 14. |
| Primary | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 10 PM (14 Hours) | 10 PM on Day -8 (Baseline), 10 PM on Day 14 (14 Hours) | IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 10 PM on Day -8 as baseline for 10 PM value on Day 14. |
| Primary | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 12 AM (16 Hours) | 12 AM on Baseline (Day -7), 12 AM on Day 15 (16 Hours) | IOP was measured using Perkins applanation tonometer at Day -8 and using standard Goldmann applanation tonometer at eligibility visit, Day -7 and Day 15. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of 2 readings was recorded as IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 12 AM on Day -7 as baseline for 12 AM value on Day 15. |
| Primary | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 4 AM (20 Hours) | 4 AM on Baseline (Day -7), 4 AM on Day 15 (20 Hours) | IOP was measured using Perkins applanation tonometer at Day -8 and using standard Goldmann applanation tonometer at eligibility visit, Day -7 and Day 15. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of 2 readings was recorded as IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 4 AM on Day -7 as baseline for 4 AM value on Day 15. |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 registered outcomesOutcomes30
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 8 Ante Meridiem (AM) (0 Hour) | 8 AM on Baseline (Day -8), 8 AM on Day 14 (0 Hour) | Per-protocol (PP) population included all participants who completed the study treatment with no major protocol violations. | mmHg | MEAN |
| PRIMARY | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 10 AM (2 Hours) | 10 AM on Baseline (Day -8), 10 AM on Day 14 (2 Hours) | PP population included all participants who completed the study treatment with no major protocol violations. | mmHg | MEAN |
| PRIMARY | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 12 Post Meridiem (PM) (4 Hours) | 12 PM on Baseline (Day -8), 12 PM on Day 14 (4 Hours) | PP population included all participants who completed the study treatment with no major protocol violations. | mmHg | MEAN |
| PRIMARY | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 2 PM (6 Hours) | 2 PM on Baseline (Day -8), 2 PM on Day 14 (6 Hours) | PP population included all participants who completed the study treatment with no major protocol violations. Here 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively. | mmHg | MEAN |
| PRIMARY | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 4 PM (8 Hours) | 4 PM on Baseline (Day -8), 4 PM on Day 14 (8 Hours) | PP population included all participants who completed the study treatment with no major protocol violations. Here 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively. | mmHg | MEAN |
| PRIMARY | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 6 PM (10 Hours) | 6 PM on Baseline (Day -8), 6 PM on Day 14 (10 Hours) | PP population included all participants who completed the study treatment with no major protocol violations. | mmHg | MEAN |
| PRIMARY | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 8 PM (12 Hours) | 8 PM on Baseline (Day -8), 8 PM on Day 14 (12 Hours) | PP population included all participants who completed the study treatment with no major protocol violations. | mmHg | MEAN |
| PRIMARY | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 10 PM (14 Hours) | 10 PM on Day -8 (Baseline), 10 PM on Day 14 (14 Hours) | PP population included all participants who completed the study treatment with no major protocol violations. | mmHg | MEAN |
| PRIMARY | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 12 AM (16 Hours) | 12 AM on Baseline (Day -7), 12 AM on Day 15 (16 Hours) | PP population included all participants who completed the study treatment with no major protocol violations. | mmHg | MEAN |
| PRIMARY | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 4 AM (20 Hours) | 4 AM on Baseline (Day -7), 4 AM on Day 15 (20 Hours) | PP population included all participants who completed the study treatment with no major protocol violations. | mmHg | MEAN |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 outcomesResults by group224
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 8 Ante Meridiem (AM) (0 Hour) | Taprenepag+Latanoprost | Baseline (Day -8) : 8 AM | 22.77 | Standard Deviation 3.264 | mmHg |
| Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 8 Ante Meridiem (AM) (0 Hour) | Taprenepag+Latanoprost Vehicle | Baseline (Day -8) : 8 AM | 22.41 | Standard Deviation 2.786 | mmHg |
| Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 8 Ante Meridiem (AM) (0 Hour) | Taprenepag+Latanoprost | Change at Day 14: 8 AM | 5.00 | Standard Deviation 2.391 | mmHg |
| Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 8 Ante Meridiem (AM) (0 Hour) | Taprenepag+Latanoprost Vehicle | Change at Day 14: 8 AM | 3.79 | Standard Deviation 2.942 | mmHg |
| Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 10 AM (2 Hours) | Taprenepag+Latanoprost | Baseline (Day -8): 10 AM | 21.40 | Standard Deviation 3.022 | mmHg |
| Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 10 AM (2 Hours) | Taprenepag+Latanoprost Vehicle | Baseline (Day -8): 10 AM | 20.82 | Standard Deviation 2.385 | mmHg |
| Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 10 AM (2 Hours) | Taprenepag+Latanoprost | Change at Day 14: 10 AM | 3.90 | Standard Deviation 2.445 | mmHg |
| Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 10 AM (2 Hours) | Taprenepag+Latanoprost Vehicle | Change at Day 14: 10 AM | 3.09 | Standard Deviation 2.822 | mmHg |
| Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 12 Post Meridiem (PM) (4 Hours) | Taprenepag+Latanoprost | Baseline (Day -8): 12 PM | 21.54 | Standard Deviation 3.514 | mmHg |
| Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 12 Post Meridiem (PM) (4 Hours) | Taprenepag+Latanoprost Vehicle | Baseline (Day -8): 12 PM | 21.45 | Standard Deviation 2.518 | mmHg |
1 to 10 of 224Source ClinicalTrials.gov
See all 224 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention Period (14 Days) | STARTED | Taprenepag+Latanoprost, Then Taprenepag+Latanoprost Vehicle | 15 | |
| First Intervention Period (14 Days) | STARTED | Taprenepag+Latanoprost Vehicle,Then Taprenepag+Latanoprost | 16 | |
| First Intervention Period (14 Days) | Treated | Taprenepag+Latanoprost, Then Taprenepag+Latanoprost Vehicle | 14 | |
| First Intervention Period (14 Days) | Treated | Taprenepag+Latanoprost Vehicle,Then Taprenepag+Latanoprost | 16 | |
| First Intervention Period (14 Days) | COMPLETED | Taprenepag+Latanoprost, Then Taprenepag+Latanoprost Vehicle | 13 | |
| First Intervention Period (14 Days) | COMPLETED | Taprenepag+Latanoprost Vehicle,Then Taprenepag+Latanoprost | 16 | |
| First Intervention Period (14 Days) | NOT COMPLETED | Taprenepag+Latanoprost, Then Taprenepag+Latanoprost Vehicle | 2 | |
| First Intervention Period (14 Days) | NOT COMPLETED | Taprenepag+Latanoprost Vehicle,Then Taprenepag+Latanoprost | 0 | |
| Washout Period (28 Days) | STARTED | Taprenepag+Latanoprost, Then Taprenepag+Latanoprost Vehicle | 13 | |
| Washout Period (28 Days) | STARTED | Taprenepag+Latanoprost Vehicle,Then Taprenepag+Latanoprost | 16 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events52
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Asthenopia | Eye disorders | Taprenepag+Latanoprost | 1 | 30 | |
| other | Asthenopia | Eye disorders | Taprenepag+Latanoprost Vehicle | 0 | 29 | |
| other | Conjunctival hyperaemia | Eye disorders | Taprenepag+Latanoprost | 13 | 30 | |
| other | Conjunctival hyperaemia | Eye disorders | Taprenepag+Latanoprost Vehicle | 13 | 29 | |
| other | Corneal disorder | Eye disorders | Taprenepag+Latanoprost | 23 | 30 | |
| other | Corneal disorder | Eye disorders | Taprenepag+Latanoprost Vehicle | 22 | 29 | |
| other | Dry eye | Eye disorders | Taprenepag+Latanoprost | 1 | 30 | |
| other | Dry eye | Eye disorders | Taprenepag+Latanoprost Vehicle | 2 | 29 | |
| other | Eye pain | Eye disorders | Taprenepag+Latanoprost | 5 | 30 | |
| other | Eye pain | Eye disorders | Taprenepag+Latanoprost Vehicle | 1 | 29 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Taprenepag+Latanoprost | ||
| Total, all-cause mortality | Taprenepag+Latanoprost Vehicle | ||
| Total, other adverse events | Taprenepag+Latanoprost | 30 | 30 |
| Total, other adverse events | Taprenepag+Latanoprost Vehicle | 28 | 29 |
| Total, serious adverse events | Taprenepag+Latanoprost | 0 | 30 |
| Total, serious adverse events | Taprenepag+Latanoprost Vehicle | 0 | 29 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Taprenepag+Latanoprost vs Taprenepag+Latanoprost Vehicle: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00934089
GET https://conductscience.org/api/trials/v1/NCT00934089/registered?page=2