Trial · NCT00538304
A Study of the Safety and Efficacy of Bimatoprost in Patients With Glaucoma or Ocular Hypertension
NCT00538304, Phase 2, Completed, Allergan; results first posted 2011-10-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of the Safety and Efficacy of Bimatoprost in Patients With Glaucoma or Ocular Hypertension. Trials, record NCT00538304. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00538304
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Safety and Efficacy of Bimatoprost in Patients With Glaucoma or Ocular Hypertension
- NCT number
- NCT00538304
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 222 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Glaucoma, Ocular Hypertension
- Interventions
- bimatoprost eye drops, placebo
- First posted
- 2007-10-02
- Last updated
- 2019-04-23
- Results first posted
- 2011-10-27
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Mean Peak Macroscopic Conjunctival Hyperemia at Month 1 | Baseline, Month 1 | Change from Baseline in macroscopic conjunctival hyperemia (or visible eye redness). Macroscopic conjunctival hyperemia is graded by the investigator who compares the patient's visual appearance of eye redness to standard photographs using a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). The peak change is calculated for each eye by subtracting the largest score across the hourly measurements at baseline from the largest score across the hourly measurements at month 1. A positive number severity grade change from baseline indicated an increase in redness. |
| Secondary | Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye at Month 1 | Month 1 | Percentage of patients with a \>= 1 unit increase in macroscopic conjunctival hyperemia in either eye at the Month 1, 8 AM time point. Macroscopic conjunctival hyperemia is graded by the investigator who compares the patient's visual appearance of eye redness to standard photographs using a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). |
| Secondary | Change From Baseline in Mean Intraocular Pressure (IOP) at Month 1 | Baseline, Month 1 | Change from baseline in mean (average) IOP at Month 1 8 AM timepoint. IOP is a measurement of the fluid pressure inside the eye. 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. |
| Secondary | Percentage of Physicians Who Were Very or Extremely Willing to Continue Patient on Drug, if Drug Were Marketed at Month 1 | Month 1 | Percentage of physicians who were very or extremely willing to continue patient on drug if drug were marketed based on their reported response to the question. Physicians were asked "Overall, based on how well this drug lowered THIS patient's IOP, balanced with any adverse events she/he may have experienced, would you consider continuing THIS medication (if the drug was marketed)?". The responses were extremely willing, very willing, somewhat willing and not willing. If not willing, physician was asked for reason. |
| Secondary | Percentage of Patients Who Were Very or Extremely Willing to Use This Glaucoma Medication at Month 1 | Month 1 | Percentage of patients who were very or extremely willing to continue to use this glaucoma medication based on their reported response to the question. Patients were asked "Overall, based on how well this drug lowered your IOP, your concern about the preservation of your vision, balanced with any side effects you may have experienced using your medication, would you be willing to continue this medication (eye drops) if your physician prescribed it?". The responses were extremely willing, very willing, somewhat willing and not willing. If not willing, patient was asked for reason. |
| Secondary | Percentage of Patients Who Reported No Change in the Appearance of Their Eyes Since the Beginning of the Study at Month 1 | Month 1 | Percentage of patients who reported no change in the appearance of their eyes since the beginning of the study. Patients were asked "Are you experiencing a change in how your eye looks now since you began your current glaucoma medication?". The responses were yes or no. If yes, patient was asked for primary reason and if better, worse or as expected based on what the doctor's office told them to expect. |
Source ClinicalTrials.gov
Outcomes6
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 Peak Macroscopic Conjunctival Hyperemia at Month 1 | Baseline, Month 1 | Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits. | Number on a scale (score) | MEAN |
| SECONDARY | Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye at Month 1 | Month 1 | Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits. | Percentage of Patients | NUMBER |
| SECONDARY | Change From Baseline in Mean Intraocular Pressure (IOP) at Month 1 | Baseline, Month 1 | Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits. | millimeters of mercury (mmHg) | MEAN |
| SECONDARY | Percentage of Physicians Who Were Very or Extremely Willing to Continue Patient on Drug, if Drug Were Marketed at Month 1 | Month 1 | Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits. | Percentage of Physicians | NUMBER |
| SECONDARY | Percentage of Patients Who Were Very or Extremely Willing to Use This Glaucoma Medication at Month 1 | Month 1 | Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits. | Percentage of Patients | NUMBER |
| SECONDARY | Percentage of Patients Who Reported No Change in the Appearance of Their Eyes Since the Beginning of the Study at Month 1 | Month 1 | Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits. | Percentage of Patients | NUMBER |
Source ClinicalTrials.gov
Results by group16
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 Peak Macroscopic Conjunctival Hyperemia at Month 1 | Bimatoprost Eye Drops | Baseline | 0.32 | Standard Deviation 0.280 | Number on a scale (score) |
| Change From Baseline in Mean Peak Macroscopic Conjunctival Hyperemia at Month 1 | Placebo | Baseline | 0.30 | Standard Deviation 0.288 | Number on a scale (score) |
| Change From Baseline in Mean Peak Macroscopic Conjunctival Hyperemia at Month 1 | Bimatoprost Eye Drops | Month 1 | 0.18 | Standard Deviation 0.456 | Number on a scale (score) |
| Change From Baseline in Mean Peak Macroscopic Conjunctival Hyperemia at Month 1 | Placebo | Month 1 | 0.02 | Standard Deviation 0.321 | Number on a scale (score) |
| Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye at Month 1 | Bimatoprost Eye Drops | 8.16 | Percentage of Patients | ||
| Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye at Month 1 | Placebo | 1.41 | Percentage of Patients | ||
| Change From Baseline in Mean Intraocular Pressure (IOP) at Month 1 | Bimatoprost Eye Drops | Baseline, 8AM | 18.2 | Standard Deviation 3.13 | millimeters of mercury (mmHg) |
| Change From Baseline in Mean Intraocular Pressure (IOP) at Month 1 | Placebo | Baseline, 8AM | 18.0 | Standard Deviation 3.34 | millimeters of mercury (mmHg) |
| Change From Baseline in Mean Intraocular Pressure (IOP) at Month 1 | Bimatoprost Eye Drops | Month 1, 8AM | -1.0 | Standard Deviation 2.64 | millimeters of mercury (mmHg) |
| Change From Baseline in Mean Intraocular Pressure (IOP) at Month 1 | Placebo | Month 1, 8AM | 3.6 | Standard Deviation 3.85 | millimeters of mercury (mmHg) |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bimatoprost Eye Drops | 151 | |
| Overall Study | STARTED | Placebo | 71 | |
| Overall Study | COMPLETED | Bimatoprost Eye Drops | 144 | |
| Overall Study | COMPLETED | Placebo | 66 | |
| Overall Study | NOT COMPLETED | Bimatoprost Eye Drops | 7 | |
| Overall Study | NOT COMPLETED | Placebo | 5 |
Source ClinicalTrials.gov
Adverse events2
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 Eye Drops | 10 | 150 | |
| other | Conjunctival hyperaemia | Eye disorders | Placebo | 2 | 71 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bimatoprost Eye Drops | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Bimatoprost Eye Drops | 10 | 150 |
| Total, other adverse events | Placebo | 2 | 71 |
| Total, serious adverse events | Bimatoprost Eye Drops | 0 | 150 |
| Total, serious adverse events | Placebo | 0 | 71 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21188155 | BACKGROUND |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Bimatoprost Eye Drops vs Placebo: 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/NCT00538304
GET https://conductscience.org/api/trials/v1/NCT00538304/registered