Trial · NCT00541242
Safety and Efficacy of Bimatoprost Compared With Latanoprost in Patients With Glaucoma or Ocular Hypertension
NCT00541242, Phase 4, Completed, Allergan; results first posted 2011-10-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Bimatoprost Compared With Latanoprost in Patients With Glaucoma or Ocular Hypertension. Trials, record NCT00541242. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00541242
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Bimatoprost Compared With Latanoprost in Patients With Glaucoma or Ocular Hypertension
- NCT number
- NCT00541242
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 586 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Ocular Hypertension, Glaucoma
- Interventions
- bimatoprost 0.03% eye drops, latanoprost 0.005% eye drops
- First posted
- 2007-10-10
- Last updated
- 2011-10-27
- Results first posted
- 2011-10-27
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 12 | Baseline, Week 12 | Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP. |
| Primary | Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 18 | Baseline, Week 18 | Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP. |
Source ClinicalTrials.gov
Outcomes2
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 Intraocular Pressure (IOP) at Week 12 | Baseline, Week 12 | Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and had at least a baseline and one follow-up visit measurement of IOP after receiving the study medication. | millimeters of mercury (mmHg) | MEAN |
| PRIMARY | Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 18 | Baseline, Week 18 | Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and had at least a baseline and one follow-up visit measurement of IOP after receiving the study medication. | millimeters of mercury (mmHg) | MEAN |
Source ClinicalTrials.gov
Results by group8
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 Intraocular Pressure (IOP) at Week 12 | Bimatoprost 0.03% Eye Drops | Baseline | 21.90 | Standard Deviation 3.656 | millimeters of mercury (mmHg) |
| Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 12 | Latanoprost 0.005% Eye Drops | Baseline | 22.16 | Standard Deviation 3.569 | millimeters of mercury (mmHg) |
| Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 12 | Bimatoprost 0.03% Eye Drops | Week 12 | -5.64 | Standard Deviation 2.968 | millimeters of mercury (mmHg) |
| Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 12 | Latanoprost 0.005% Eye Drops | Week 12 | -4.89 | Standard Deviation 2.872 | millimeters of mercury (mmHg) |
| Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 18 | Bimatoprost 0.03% Eye Drops | Baseline | 21.90 | Standard Deviation 3.656 | millimeters of mercury (mmHg) |
| Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 18 | Latanoprost 0.005% Eye Drops | Baseline | 22.16 | Standard Deviation 3.569 | millimeters of mercury (mmHg) |
| Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 18 | Bimatoprost 0.03% Eye Drops | Week 18 | -5.77 | Standard Deviation 3.023 | millimeters of mercury (mmHg) |
| Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 18 | Latanoprost 0.005% Eye Drops | Week 18 | -5.09 | Standard Deviation 2.709 | millimeters of mercury (mmHg) |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1 | STARTED | Bimatoprost 0.03% Eye Drops | 0 | |
| Treatment Period 1 | STARTED | Latanoprost 0.005% Eye Drops | 586 | |
| Treatment Period 1 | COMPLETED | Bimatoprost 0.03% Eye Drops | 0 | |
| Treatment Period 1 | COMPLETED | Latanoprost 0.005% Eye Drops | 586 | |
| Treatment Period 1 | NOT COMPLETED | Bimatoprost 0.03% Eye Drops | 0 | |
| Treatment Period 1 | NOT COMPLETED | Latanoprost 0.005% Eye Drops | 0 | |
| Treatment Period 2 | STARTED | Bimatoprost 0.03% Eye Drops | 270 | |
| Treatment Period 2 | STARTED | Latanoprost 0.005% Eye Drops | 273 | |
| Treatment Period 2 | COMPLETED | Bimatoprost 0.03% Eye Drops | 261 | |
| Treatment Period 2 | COMPLETED | Latanoprost 0.005% Eye Drops | 266 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events28
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 | Conjunctival hyperaemia | Eye disorders | Bimatoprost 0.03% Eye Drops | 59 | 269 | |
| other | Conjunctival hyperaemia | Eye disorders | Latanoprost 0.005% Eye Drops | 89 | 586 | |
| serious | Cellulitis | Infections and infestations | Bimatoprost 0.03% Eye Drops | 0 | 269 | |
| serious | Cellulitis | Infections and infestations | Latanoprost 0.005% Eye Drops | 1 | 586 | |
| serious | Coronary artery disease | Cardiac disorders | Bimatoprost 0.03% Eye Drops | 0 | 269 | |
| serious | Coronary artery disease | Cardiac disorders | Latanoprost 0.005% Eye Drops | 1 | 586 | |
| serious | Atrial fibrillation | Cardiac disorders | Bimatoprost 0.03% Eye Drops | 1 | 269 | |
| serious | Atrial fibrillation | Cardiac disorders | Latanoprost 0.005% Eye Drops | 0 | 586 | |
| serious | Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Bimatoprost 0.03% Eye Drops | 1 | 269 | |
| serious | Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Latanoprost 0.005% Eye Drops | 0 | 586 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bimatoprost 0.03% Eye Drops | ||
| Total, all-cause mortality | Latanoprost 0.005% Eye Drops | ||
| Total, other adverse events | Bimatoprost 0.03% Eye Drops | 59 | 269 |
| Total, other adverse events | Latanoprost 0.005% Eye Drops | 89 | 586 |
| Total, serious adverse events | Bimatoprost 0.03% Eye Drops | 4 | 269 |
| Total, serious adverse events | Latanoprost 0.005% Eye Drops | 11 | 586 |
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 |
|---|
| Bimatoprost 0.03% Eye Drops vs Latanoprost 0.005% Eye Drops: 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/NCT00541242
GET https://conductscience.org/api/trials/v1/NCT00541242/events?page=2