Trial · NCT00383019
A Study Comparing Xalacom And Xalatan In Patients With Primary Open Angle Glaucoma (POAG) Or Ocular Hypertension (OH).
NCT00383019, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2009-05-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study Comparing Xalacom And Xalatan In Patients With Primary Open Angle Glaucoma (POAG) Or Ocular Hypertension (OH). Trials, record NCT00383019. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00383019
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Comparing Xalacom And Xalatan In Patients With Primary Open Angle Glaucoma (POAG) Or Ocular Hypertension (OH).
- NCT number
- NCT00383019
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 300 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Glaucoma, Ocular Hypertension
- Interventions
- Xalatan, Xalacom
- First posted
- 2006-10-02
- Last updated
- 2021-09-08
- Results first posted
- 2009-05-27
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change of Intraocular Pressure (IOP) From Baseline to Week 8 | Baseline to Week 8 | Value at Week 8 minus value at baseline |
| Secondary | Change of IOP From Baseline to Week 4 | Baseline to Week 4 | Value at Week 4 minus value at baseline |
| Secondary | Number of Subjects With an IOP of <=15 mmHg at Week 8 | Week 8 | Number of subjects who achieved IOP reduction to 15 mmHg or below at Week 8 |
| Secondary | Number of Subjects With an IOP of <=16 mmHg at Week 8 | Week 8 | Number of subjects who achieved IOP reduction to 16 mmHg or below at Week 8 |
| Secondary | Percent Change of IOP From Baseline to Week 8 | Baseline to Week 8 | Value at Week 8 minus value at baseline was divided by baseline value, then multiplied by 100 |
| Secondary | Number of Subjects With an IOP of <=18 mmHg at Week 8 | Week 8 | Number of subjects who achieved IOP reduction to 18 mmHg or below at Week 8 |
| Secondary | Number of Subjects With an IOP Reduction of >=2 mmHg From Baseline to Week 8 | Baseline to Week 8 | Number of subjects whose IOP were reduced by 2 mmHg or more at Week 8 from baseline |
| Secondary | Number of Subjects With an IOP Reduction of >=3 mmHg From Baseline to Week 8 | Baseline to Week 8 | Number of subjects whose IOP were reduced by 3 mmHg or more at Week 8 from baseline |
| Secondary | Number of Subjects With an IOP of <=17 mmHg at Week 8 | Week 8 | Number of subjects who achieved IOP reduction to 17 mmHg or below at Week 8 |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change of Intraocular Pressure (IOP) From Baseline to Week 8 | Baseline to Week 8 | The primary efficacy analysis population was the Intent-to-treat population (ITT) which consisted of all subjects treated with the study drug as randomized. If there were any missing IOP values at Week 8, the data were supplemented by LOCF (Last Observation Carried Forward) using data at Week 4. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change of IOP From Baseline to Week 4 | Baseline to Week 4 | ITT | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Subjects With an IOP of <=15 mmHg at Week 8 | Week 8 | The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With an IOP of <=16 mmHg at Week 8 | Week 8 | The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change of IOP From Baseline to Week 8 | Baseline to Week 8 | The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Subjects With an IOP of <=18 mmHg at Week 8 | Week 8 | The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With an IOP Reduction of >=2 mmHg From Baseline to Week 8 | Baseline to Week 8 | The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With an IOP Reduction of >=3 mmHg From Baseline to Week 8 | Baseline to Week 8 | The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With an IOP of <=17 mmHg at Week 8 | Week 8 | The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change of Intraocular Pressure (IOP) From Baseline to Week 8 | KP2035 Group | -2.59 | 95% Confidence Interval -2.92 to -2.25 | mmHg | |
| Change of Intraocular Pressure (IOP) From Baseline to Week 8 | Xalatan Group | -1.62 | 95% Confidence Interval -1.96 to -1.28 | mmHg | |
| Change of IOP From Baseline to Week 4 | KP2035 Group | -2.50 | 95% Confidence Interval -2.83 to -2.17 | mmHg | |
| Change of IOP From Baseline to Week 4 | Xalatan Group | -1.17 | 95% Confidence Interval -1.50 to -0.84 | mmHg | |
| Number of Subjects With an IOP of <=15 mmHg at Week 8 | KP2035 Group | 36 | Participants | ||
| Number of Subjects With an IOP of <=15 mmHg at Week 8 | Xalatan Group | 13 | Participants | ||
| Number of Subjects With an IOP of <=16 mmHg at Week 8 | KP2035 Group | 60 | Participants | ||
| Number of Subjects With an IOP of <=16 mmHg at Week 8 | Xalatan Group | 35 | Participants | ||
| Percent Change of IOP From Baseline to Week 8 | KP2035 Group | -12.67 | 95% Confidence Interval -14.40 to -10.93 | percent change | |
| Percent Change of IOP From Baseline to Week 8 | Xalatan Group | -7.69 | 95% Confidence Interval -9.42 to -5.95 | percent change |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | KP2035 Group | 144 | |
| Overall Study | STARTED | Xalatan Group | 145 | |
| Overall Study | COMPLETED | KP2035 Group | 139 | |
| Overall Study | COMPLETED | Xalatan Group | 143 | |
| Overall Study | NOT COMPLETED | KP2035 Group | 5 | |
| Overall Study | NOT COMPLETED | Xalatan Group | 2 |
Source ClinicalTrials.gov
Adverse events92
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 | Conjunctivitis | Eye disorders | KP2035 Group | 2 | 144 | |
| other | Conjunctivitis | Eye disorders | Xalatan Group | 1 | 145 | |
| other | Retinal tear | Eye disorders | KP2035 Group | 1 | 144 | |
| other | Retinal tear | Eye disorders | Xalatan Group | 0 | 145 | |
| other | Eye irritation | Eye disorders | KP2035 Group | 25 | 144 | |
| other | Eye irritation | Eye disorders | Xalatan Group | 2 | 145 | |
| other | Nasopharyngitis | Infections and infestations | KP2035 Group | 6 | 144 | |
| other | Nasopharyngitis | Infections and infestations | Xalatan Group | 2 | 145 | |
| other | Tinea pedis | Infections and infestations | KP2035 Group | 1 | 144 | |
| other | Tinea pedis | Infections and infestations | Xalatan Group | 0 | 145 |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | KP2035 Group | 0 | 144 |
| Total, all-cause mortality | Xalatan Group | 0 | 145 |
| Total, other adverse events | KP2035 Group | 51 | 144 |
| Total, other adverse events | Xalatan Group | 29 | 145 |
| Total, serious adverse events | KP2035 Group | 1 | 144 |
| Total, serious adverse events | Xalatan Group | 2 | 145 |
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 comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| KP2035 Group vs Xalatan Group: Number of Subjects With an IOP of <=18 mmHg at Week 8 | Trial comparisons |
| KP2035 Group vs Xalatan Group: Number of Subjects With an IOP of <=16 mmHg at Week 8 | Trial comparisons |
| KP2035 Group vs Xalatan Group: Number of Subjects With an IOP of <=15 mmHg at Week 8 | Trial comparisons |
| KP2035 Group vs Xalatan Group: Number of Subjects With an IOP Reduction of >=3 mmHg From Baseline to Week 8 | Trial comparisons |
| KP2035 Group vs Xalatan Group: Number of Subjects With an IOP Reduction of >=2 mmHg From Baseline to Week 8 | Trial comparisons |
| KP2035 Group vs Xalatan Group: deaths from any cause | Trial comparisons |
| KP2035 Group vs Xalatan Group: Number of Subjects With an IOP of <=17 mmHg at Week 8 | Trial comparisons |
| KP2035 Group vs Xalatan Group: serious adverse events | 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/NCT00383019
GET https://conductscience.org/api/trials/v1/NCT00383019/events?page=2