Trial · NCT01177098
Safety and Efficacy of a New Formulation of Bimatoprost/Timolol Ophthalmic Solution Compared With Bimatoprost/Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
NCT01177098, Phase 3, Completed, Allergan; results first posted 2013-03-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of a New Formulation of Bimatoprost/Timolol Ophthalmic Solution Compared With Bimatoprost/Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension. Trials, record NCT01177098. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01177098
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of a New Formulation of Bimatoprost/Timolol Ophthalmic Solution Compared With Bimatoprost/Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
- NCT number
- NCT01177098
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 561 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Glaucoma, Ocular Hypertension
- Interventions
- bimatoprost /timolol formulation A fixed combination ophthalmic solution, bimatoprost/timolol fixed combination ophthalmic solution
- First posted
- 2010-08-06
- Last updated
- 2013-03-29
- Other registries' IDs
- eudract:2010-021507-24
- Results first posted
- 2013-03-12
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 Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 | Baseline, Week 12 | Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement). |
| Primary | Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2 | Week 2 | Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 2 at Hour 0, Hour 2 and Hour 8. |
| Primary | Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6 | Week 6 | Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 6 at Hour 0, Hour 2 and Hour 8. |
| Primary | Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 | Week 12 | Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 12 at Hour 0, Hour 2 and Hour 8. |
| Secondary | Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12 | Baseline, Week 12 | Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement). |
| Secondary | Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12 | Baseline, Week 12 | Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8. Average eye IOP is defined as the average of the IOP in both eyes. A negative number change from baseline indicates a reduction in IOP (improvement). |
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 Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 | Baseline, Week 12 | Per-protocol population included randomized participants who did not have a protocol violation that significantly affected the conduct or the results of the trial. | mm Hg | MEAN |
| PRIMARY | Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2 | Week 2 | Intent-to-treat population included all randomized participants. | mm Hg | MEAN |
| SECONDARY | Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12 | Baseline, Week 12 | Intent-to-treat population included all randomized participants. | mm Hg | MEAN |
| SECONDARY | Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12 | Baseline, Week 12 | Intent-to-treat population included all randomized participants. | mm Hg | MEAN |
| PRIMARY | Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6 | Week 6 | Intent-to-treat population included all randomized participants. | mm Hg | MEAN |
| PRIMARY | Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 | Week 12 | Intent-to-treat population included all randomized participants. | mm Hg | MEAN |
Source ClinicalTrials.gov
Results by group54
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 Each Hour Evaluated at Week 12 | Bimatoprost/Timolol Formulation A | Baseline_Hour 0 | 25.41 | Standard Deviation 2.232 | mm Hg |
| Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 | Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | Baseline_Hour 0 | 25.38 | Standard Deviation 2.209 | mm Hg |
| Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 | Bimatoprost/Timolol Formulation A | Baseline_Hour 2 (n=255,260) | 24.79 | Standard Deviation 2.676 | mm Hg |
| Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 | Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | Baseline_Hour 2 (n=255,260) | 24.72 | Standard Deviation 2.470 | mm Hg |
| Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 | Bimatoprost/Timolol Formulation A | Baseline_Hour 8 (n=254,259) | 23.88 | Standard Deviation 3.008 | mm Hg |
| Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 | Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | Baseline_Hour 8 (n=254,259) | 23.82 | Standard Deviation 2.747 | mm Hg |
| Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 | Bimatoprost/Timolol Formulation A | Change from baseline at Week 12_Hour 0 (n=244,237) | -9.06 | Standard Deviation 3.216 | mm Hg |
| Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 | Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | Change from baseline at Week 12_Hour 0 (n=244,237) | -8.72 | Standard Deviation 3.088 | mm Hg |
| Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 | Bimatoprost/Timolol Formulation A | Change from baseline at Week 12_Hour 2 (n=235,235) | -8.53 | Standard Deviation 3.520 | mm Hg |
| Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 | Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | Change from baseline at Week 12_Hour 2 (n=235,235) | -8.38 | Standard Deviation 3.297 | mm Hg |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 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/Timolol Formulation A | 278 | |
| Overall Study | STARTED | Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | 283 | |
| Overall Study | COMPLETED | Bimatoprost/Timolol Formulation A | 269 | |
| Overall Study | COMPLETED | Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | 271 | |
| Overall Study | NOT COMPLETED | Bimatoprost/Timolol Formulation A | 9 | |
| Overall Study | NOT COMPLETED | Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | 12 |
Source ClinicalTrials.gov
Adverse events18
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/Timolol Formulation A | 59 | 278 | |
| other | Conjunctival hyperaemia | Eye disorders | Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | 55 | 282 | |
| serious | Intermittent claudication | Vascular disorders | Bimatoprost/Timolol Formulation A | 1 | 278 | |
| serious | Intermittent claudication | Vascular disorders | Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | 0 | 282 | |
| serious | Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | Bimatoprost/Timolol Formulation A | 1 | 278 | |
| serious | Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | 0 | 282 | |
| serious | Osteoarthritis | Musculoskeletal and connective tissue disorders | Bimatoprost/Timolol Formulation A | 1 | 278 | |
| serious | Osteoarthritis | Musculoskeletal and connective tissue disorders | Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | 0 | 282 | |
| serious | Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Bimatoprost/Timolol Formulation A | 1 | 278 | |
| serious | Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | 0 | 282 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bimatoprost/Timolol Formulation A | ||
| Total, all-cause mortality | Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | ||
| Total, other adverse events | Bimatoprost/Timolol Formulation A | 59 | 278 |
| Total, other adverse events | Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | 55 | 282 |
| Total, serious adverse events | Bimatoprost/Timolol Formulation A | 4 | 278 |
| Total, serious adverse events | Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | 4 | 282 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24667994 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Bimatoprost/Timolol Formulation A vs Bimatoprost/Timolol Fixed Combination 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/NCT01177098
GET https://conductscience.org/api/trials/v1/NCT01177098/results?page=2