Trial · NCT01099774
Safety and Efficacy of Different Formulations of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
NCT01099774, Phase 3, Completed, Allergan; results first posted 2012-04-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Different Formulations of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension. Trials, record NCT01099774. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01099774
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Different Formulations of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
- NCT number
- NCT01099774
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 597 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Glaucoma, Ocular Hypertension
- Interventions
- Bimatoprost 0.03% Formulation B Ophthalmic Solution, Bimatoprost 0.03% Ophthalmic Solution
- First posted
- 2010-04-08
- Last updated
- 2019-04-17
- Results first posted
- 2012-04-27
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12 | Baseline, Week 12 | Change from baseline in worse eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements in the worse eye were evaluated at hours 0, 2, and 8. A negative number change from baseline indicated a reduction in IOP, and a positive number change from baseline indicated an increase in IOP. |
| Primary | Average Eye IOP at Week 12 | Baseline, Week 12 | Average Eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. Baseline data are included for reference only. |
| Primary | Average Eye IOP at Week 6 | Week 6 | Average Eye IOP at Week 6 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. |
| Primary | Average Eye IOP at Week 2 | Week 2 | Average Eye IOP at Week 2 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. |
Source ClinicalTrials.gov
Outcomes4
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 Worse Eye Intraocular Pressure (IOP) at Week 12 | Baseline, Week 12 | Per Protocol Population: All randomized patients who did not have a protocol violation that significantly affected the conduct or the results of the trial. | Millimeters of Mercury (mmHg) | MEAN |
| PRIMARY | Average Eye IOP at Week 12 | Baseline, Week 12 | Intent to Treat Population: all randomized patients. | Millimeters of Mercury (mmHg) | MEAN |
| PRIMARY | Average Eye IOP at Week 6 | Week 6 | Intent to Treat Population: all randomized patients. | Millimeters of Mercury (mmHg) | MEAN |
| PRIMARY | Average Eye IOP at Week 2 | Week 2 | Intent to Treat Population: all randomized patients. | Millimeters of Mercury (mmHg) | MEAN |
Source ClinicalTrials.gov
Results by group36
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 Worse Eye Intraocular Pressure (IOP) at Week 12 | Bimatoprost 0.03% Formulation B Ophthalmic Solution | Baseline Hour 0 | 24.90 | Standard Deviation 2.364 | Millimeters of Mercury (mmHg) |
| Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12 | Bimatoprost 0.03% Ophthalmic Solution | Baseline Hour 0 | 24.86 | Standard Deviation 2.161 | Millimeters of Mercury (mmHg) |
| Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12 | Bimatoprost 0.03% Formulation B Ophthalmic Solution | Baseline Hour 2 | 23.79 | Standard Deviation 2.992 | Millimeters of Mercury (mmHg) |
| Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12 | Bimatoprost 0.03% Ophthalmic Solution | Baseline Hour 2 | 23.78 | Standard Deviation 2.753 | Millimeters of Mercury (mmHg) |
| Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12 | Bimatoprost 0.03% Formulation B Ophthalmic Solution | Baseline Hour 8 | 22.81 | Standard Deviation 3.168 | Millimeters of Mercury (mmHg) |
| Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12 | Bimatoprost 0.03% Ophthalmic Solution | Baseline Hour 8 | 22.80 | Standard Deviation 3.301 | Millimeters of Mercury (mmHg) |
| Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12 | Bimatoprost 0.03% Formulation B Ophthalmic Solution | Change from Baseline Hour 0 at Week 12 | -7.49 | Standard Deviation 2.900 | Millimeters of Mercury (mmHg) |
| Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12 | Bimatoprost 0.03% Ophthalmic Solution | Change from Baseline Hour 0 at Week 12 | -7.77 | Standard Deviation 3.029 | Millimeters of Mercury (mmHg) |
| Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12 | Bimatoprost 0.03% Formulation B Ophthalmic Solution | Change from Baseline Hour 2 at Week 12 | -7.06 | Standard Deviation 3.333 | Millimeters of Mercury (mmHg) |
| Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12 | Bimatoprost 0.03% Ophthalmic Solution | Change from Baseline Hour 2 at Week 12 | -7.11 | Standard Deviation 3.192 | Millimeters of Mercury (mmHg) |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 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 0.03% Formulation B Ophthalmic Solution | 302 | |
| Overall Study | STARTED | Bimatoprost 0.03% Ophthalmic Solution | 295 | |
| Overall Study | COMPLETED | Bimatoprost 0.03% Formulation B Ophthalmic Solution | 296 | |
| Overall Study | COMPLETED | Bimatoprost 0.03% Ophthalmic Solution | 289 | |
| Overall Study | NOT COMPLETED | Bimatoprost 0.03% Formulation B Ophthalmic Solution | 6 | |
| Overall Study | NOT COMPLETED | Bimatoprost 0.03% Ophthalmic Solution | 6 |
Source ClinicalTrials.gov
Adverse events16
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% Formulation B Ophthalmic Solution | 72 | 301 | |
| other | Conjunctival Hyperaemia | Eye disorders | Bimatoprost 0.03% Ophthalmic Solution | 77 | 295 | |
| serious | Ovarian Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Bimatoprost 0.03% Formulation B Ophthalmic Solution | 1 | 301 | |
| serious | Ovarian Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Bimatoprost 0.03% Ophthalmic Solution | 0 | 295 | |
| serious | Spinal Compression Fracture | Injury, poisoning and procedural complications | Bimatoprost 0.03% Formulation B Ophthalmic Solution | 1 | 301 | |
| serious | Spinal Compression Fracture | Injury, poisoning and procedural complications | Bimatoprost 0.03% Ophthalmic Solution | 0 | 295 | |
| serious | Atrial Fibrillation | Cardiac disorders | Bimatoprost 0.03% Formulation B Ophthalmic Solution | 0 | 301 | |
| serious | Atrial Fibrillation | Cardiac disorders | Bimatoprost 0.03% Ophthalmic Solution | 1 | 295 | |
| serious | Convulsion | Nervous system disorders | Bimatoprost 0.03% Formulation B Ophthalmic Solution | 0 | 301 | |
| serious | Convulsion | Nervous system disorders | Bimatoprost 0.03% Ophthalmic Solution | 1 | 295 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bimatoprost 0.03% Formulation B Ophthalmic Solution | ||
| Total, all-cause mortality | Bimatoprost 0.03% Ophthalmic Solution | ||
| Total, other adverse events | Bimatoprost 0.03% Formulation B Ophthalmic Solution | 72 | 301 |
| Total, other adverse events | Bimatoprost 0.03% Ophthalmic Solution | 77 | 295 |
| Total, serious adverse events | Bimatoprost 0.03% Formulation B Ophthalmic Solution | 2 | 301 |
| Total, serious adverse events | Bimatoprost 0.03% Ophthalmic Solution | 5 | 295 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23743437 | 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 0.03% Formulation B Ophthalmic Solution vs Bimatoprost 0.03% Ophthalmic Solution: 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/NCT01099774
GET https://conductscience.org/api/trials/v1/NCT01099774/results?page=2