Trial · NCT00572455
Safety and Efficacy of PF-04217329 in Patients With Glaucoma or Elevated Eye Pressure.
NCT00572455, Phase 2, Completed, Pfizer; results first posted 2021-04-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of PF-04217329 in Patients With Glaucoma or Elevated Eye Pressure. Trials, record NCT00572455. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00572455
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of PF-04217329 in Patients With Glaucoma or Elevated Eye Pressure.
- NCT number
- NCT00572455
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 318 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Primary Open-Angle Glaucoma, Ocular Hypertension
- Interventions
PF-04217329 - Lowest Dose, PF-04217329 - Low Dose, PF-04217329 - Middle Dose, PF-04217329 - High Middle Dose, PF-04217329 - High Dose, PF-4217329 - Highest Dose, PF-04217329 - Vehicle, Latanoprost Vehicle, PF-04217329 - Low Dose, Latanoprost Vehicle, PF-04217329 - Middle Dose, Latanoprost Vehicle, PF-04217329 - High Dose, Latanoprost 0.005%, PF-04217329 - Low Dose, Latanoprost 0.005%, PF-04217329 - Middle Dose, Latanoprost 0.005%, PF-04217329 - High Dose, Latanoprost 0.005%, PF-04217329 - Vehicle
- First posted
- 2007-12-13
- Last updated
- 2021-04-30
- Results first posted
- 2021-04-30
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I | Stage I: Baseline, Day 14 | Diurnal IOP was defined as the mean IOP over 24 hours. IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), the 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 = diurnal IOP at baseline - diurnal IOP at Day 14. |
| Primary | Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 28: Stage II | Stage II: Baseline, Day 28 | Diurnal IOP was defined as the mean IOP over 24 hours. IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the 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 = diurnal IOP at baseline - diurnal IOP at Day 28. |
| Primary | Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage I | Stage I: Day 1 up to 28 days after last dose of study medication (up to 44 days) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study medication and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Ocular AEs were the events which were localized in the ocular region. |
| Primary | Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage II | Stage II: Day 1 up to 28 days after last dose of study medication (up to 59 days) | An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study medication and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Ocular AEs were the events which were localized in the ocular region. |
| Secondary | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Stage I: 8 ante meridiem (AM) on Day 1, 8 AM, 10 AM, 1 post meridiem (PM), 4 PM on Day 7, and 14 | IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the 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. |
| Secondary | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Stage I: 8 AM, 10 AM, 1 PM, 4 PM on Day 0 (Baseline), 8 AM on Day 1, 8 AM, 10 AM, 1 PM, 4 PM on Day 7, and 14 | IOP was measured using Goldmann applanation tonometer. IOP was measured in both eyes, and the eye with higher IOP reading at 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the 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 = baseline IOP - post-baseline IOP. Change at various post-dose time points was calculated from the baseline values at same time points on Day 0 (for example, value at 8 AM on Day 0 was used as baseline value for 8 AM value on Day 1, 7 and 14). |
| Secondary | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Stage II: 8 AM on Day 1; 8 AM, 10 AM, 1 PM, 4 PM on Days 7, 14, and 28 | IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the 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. |
| Secondary | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Stage II: 8 AM, 10 AM, 1 PM, and 4 PM on Day 0 (Baseline), 8 AM on Day 1; 8 AM, 10 AM, 1 PM, 4 PM on Days 7, 14, and 28 | IOP was measured using Goldmann applanation tonometer. IOP was measured in both eyes, and the eye with higher IOP reading at 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the 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 = baseline IOP - post-baseline IOP. Change at various post-dose time points was calculated from the baseline values at same time points on Day 0 (for example, value at 8 AM on Day 0 was used as baseline value for 8 AM value on Day 1, 7, 14 and 28). |
| Secondary | Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage I | Stage I: Day 1 up to Day 14 | Percentage of participants who reached an IOP of less than or equal to (\<=) 18 mmHg by post-eligibility visit (Day 1) and maintained an IOP \<= 18 mm Hg across all post-eligibility visits in Stage I were reported. IOP was measured using Goldmann applanation tonometer. |
| Secondary | Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage II | Stage II: Day 1 up to Day 28 | Percentage of participants who reached an IOP \<= 18 mmHg by post-eligibility visit (Day 1) and maintained an IOP \<= 18 mm Hg across all post-eligibility visits in Stage II were reported. IOP was measured using Goldmann applanation tonometer. |
Source ClinicalTrials.gov
Outcomes10
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 Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I | Stage I: Baseline, Day 14 | ITT population included all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used to impute missing values. | mmHg | MEAN |
| PRIMARY | Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 28: Stage II | Stage II: Baseline, Day 28 | ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values. | mmHg | MEAN |
| PRIMARY | Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage I | Stage I: Day 1 up to 28 days after last dose of study medication (up to 44 days) | ITT population included all randomized participants who received at least 1 dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage II | Stage II: Day 1 up to 28 days after last dose of study medication (up to 59 days) | ITT population included all randomized participants who received at least 1 dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Stage I: 8 ante meridiem (AM) on Day 1, 8 AM, 10 AM, 1 post meridiem (PM), 4 PM on Day 7, and 14 | ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values. Here 'number analyzed' signifies participants evaluable each specified time points for each group, respectively. | mmHg | MEAN |
| SECONDARY | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Stage I: 8 AM, 10 AM, 1 PM, 4 PM on Day 0 (Baseline), 8 AM on Day 1, 8 AM, 10 AM, 1 PM, 4 PM on Day 7, and 14 | ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values. Here 'number analyzed' signifies participants evaluable each specified time points for each group, respectively. | mmHg | MEAN |
| SECONDARY | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Stage II: 8 AM on Day 1; 8 AM, 10 AM, 1 PM, 4 PM on Days 7, 14, and 28 | ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values. Here 'number analyzed' signifies participants evaluable each specified time points for each group, respectively. | mmHg | MEAN |
| SECONDARY | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Stage II: 8 AM, 10 AM, 1 PM, and 4 PM on Day 0 (Baseline), 8 AM on Day 1; 8 AM, 10 AM, 1 PM, 4 PM on Days 7, 14, and 28 | ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values. Here 'number analyzed' signifies participants evaluable each specified time points for each group, respectively. | mmHg | MEAN |
| SECONDARY | Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage I | Stage I: Day 1 up to Day 14 | ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage II | Stage II: Day 1 up to Day 28 | ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group490
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 Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I | Taprenepag 0.0025% (Stage I) | Baseline | 25.97 | Standard Deviation 2.420 | mmHg |
| Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I | Taprenepag 0.005% (Stage I) | Baseline | 26.25 | Standard Deviation 2.400 | mmHg |
| Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I | Taprenepag 0.01% (Stage I) | Baseline | 25.90 | Standard Deviation 2.094 | mmHg |
| Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I | Taprenepag 0.015% (Stage I) | Baseline | 26.44 | Standard Deviation 1.560 | mmHg |
| Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I | Taprenepag 0.02% (Stage I) | Baseline | 28.10 | Standard Deviation 3.102 | mmHg |
| Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I | Taprenepag 0.03% (Stage I) | Baseline | 26.26 | Standard Deviation 1.831 | mmHg |
| Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I | Taprenepag Vehicle (Stage I) | Baseline | 26.04 | Standard Deviation 2.182 | mmHg |
| Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I | Taprenepag 0.0025% (Stage I) | Change at Day 14 | 3.65 | Standard Deviation 1.749 | mmHg |
| Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I | Taprenepag 0.005% (Stage I) | Change at Day 14 | 5.40 | Standard Deviation 2.508 | mmHg |
| Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I | Taprenepag 0.01% (Stage I) | Change at Day 14 | 7.18 | Standard Deviation 2.749 | mmHg |
1 to 10 of 490Source ClinicalTrials.gov
See all 490 results by groupParticipant flow98
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Stage I (14 Days) | STARTED | Taprenepag 0.0025% (Stage I) | 9 | |
| Stage I (14 Days) | STARTED | Taprenepag 0.005% (Stage I) | 9 | |
| Stage I (14 Days) | STARTED | Taprenepag 0.01% (Stage I) | 9 | |
| Stage I (14 Days) | STARTED | Taprenepag 0.015% (Stage I) | 10 | |
| Stage I (14 Days) | STARTED | Taprenepag 0.02% (Stage I) | 9 | |
| Stage I (14 Days) | STARTED | Taprenepag 0.03% (Stage I) | 9 | |
| Stage I (14 Days) | STARTED | Taprenepag Vehicle (Stage I) | 12 | |
| Stage I (14 Days) | STARTED | Latanoprost Vehicle and Taprenepag 0.005% (Stage II) | 0 | |
| Stage I (14 Days) | STARTED | Latanoprost Vehicle and Taprenepag 0.01% (Stage II) | 0 | |
| Stage I (14 Days) | STARTED | Latanoprost Vehicle and Taprenepag 0.015% (Stage II) | 0 |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 participant flowAdverse events1,246
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 | Ear discomfort | Ear and labyrinth disorders | Taprenepag 0.0025% (Stage I) | 0 | 9 | |
| other | Ear discomfort | Ear and labyrinth disorders | Taprenepag 0.005% (Stage I) | 0 | 9 | |
| other | Ear discomfort | Ear and labyrinth disorders | Taprenepag 0.01% (Stage I) | 0 | 9 | |
| other | Ear discomfort | Ear and labyrinth disorders | Taprenepag 0.015% (Stage I) | 0 | 10 | |
| other | Ear discomfort | Ear and labyrinth disorders | Taprenepag 0.02% (Stage I) | 0 | 9 | |
| other | Ear discomfort | Ear and labyrinth disorders | Taprenepag 0.03% (Stage I) | 0 | 9 | |
| other | Ear discomfort | Ear and labyrinth disorders | Taprenepag Vehicle (Stage I) | 0 | 12 | |
| other | Ear discomfort | Ear and labyrinth disorders | Latanoprost Vehicle and Taprenepag 0.005% (Stage II) | 0 | 35 | |
| other | Ear discomfort | Ear and labyrinth disorders | Latanoprost Vehicle and Taprenepag 0.01% (Stage II) | 0 | 36 | |
| other | Ear discomfort | Ear and labyrinth disorders | Latanoprost Vehicle and Taprenepag 0.015% (Stage II) | 1 | 36 |
1 to 10 of 1,246Source ClinicalTrials.gov
See all 1,246 adverse eventsAdverse event totals42
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Taprenepag 0.0025% (Stage I) | ||
| Total, all-cause mortality | Taprenepag 0.005% (Stage I) | ||
| Total, all-cause mortality | Taprenepag 0.01% (Stage I) | ||
| Total, all-cause mortality | Taprenepag 0.015% (Stage I) | ||
| Total, all-cause mortality | Taprenepag 0.02% (Stage I) | ||
| Total, all-cause mortality | Taprenepag 0.03% (Stage I) | ||
| Total, all-cause mortality | Taprenepag Vehicle (Stage I) | ||
| Total, all-cause mortality | Latanoprost Vehicle and Taprenepag 0.005% (Stage II) | ||
| Total, all-cause mortality | Latanoprost Vehicle and Taprenepag 0.01% (Stage II) | ||
| Total, all-cause mortality | Latanoprost Vehicle and Taprenepag 0.015% (Stage II) |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21851167 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00572455
GET https://conductscience.org/api/trials/v1/NCT00572455/results?page=2