Trial · NCT01229462
Safety and Efficacy of Brimonidine Tartrate/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension
NCT01229462, Not applicable, Completed, Allergan; results first posted 2012-09-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Brimonidine Tartrate/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension. Trials, record NCT01229462. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01229462
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Brimonidine Tartrate/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension
- NCT number
- NCT01229462
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 238 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Glaucoma, Ocular Hypertension
- Interventions
- brimonidine tartrate/timolol fixed combination ophthalmic solution, brimonidine tartrate ophthalmic solution, timolol ophthalmic solution, fixed combination vehicle
- First posted
- 2010-10-27
- Last updated
- 2012-09-14
- Results first posted
- 2012-09-14
Source ClinicalTrials.gov
Registered outcomes1
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) in the Study Eye at Week 4 | Baseline, Week 4 | Intraocular pressure (IOP) was measured in the study eye at baseline and Week 4. IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). |
Source ClinicalTrials.gov
Outcomes1
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) in the Study Eye at Week 4 | Baseline, Week 4 | Intent-to-treat population consisted of all randomized participants. | mm Hg | MEAN |
Source ClinicalTrials.gov
Results by group4
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) in the Study Eye at Week 4 | Combigan® | Baseline | 25.07 | Standard Deviation 3.737 | mm Hg |
| Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4 | Alphagan® and Timolol Concurrent | Baseline | 24.53 | Standard Deviation 2.926 | mm Hg |
| Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4 | Combigan® | Change from baseline at Week 4 | -6.21 | Standard Deviation 3.550 | mm Hg |
| Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4 | Alphagan® and Timolol Concurrent | Change from baseline at Week 4 | -5.70 | Standard Deviation 3.469 | mm Hg |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Combigan® | 120 | |
| Overall Study | STARTED | Alphagan® and Timolol Concurrent | 118 | |
| Overall Study | COMPLETED | Combigan® | 115 | |
| Overall Study | COMPLETED | Alphagan® and Timolol Concurrent | 109 | |
| Overall Study | NOT COMPLETED | Combigan® | 5 | |
| Overall Study | NOT COMPLETED | Alphagan® and Timolol Concurrent | 9 |
Source ClinicalTrials.gov
Adverse events4
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 |
|---|---|---|---|---|---|---|
| serious | Sudden hearing loss | Ear and labyrinth disorders | Combigan® | 1 | 120 | |
| serious | Sudden hearing loss | Ear and labyrinth disorders | Alphagan® and Timolol Concurrent | 0 | 116 | |
| serious | VIth nerve paralysis | Nervous system disorders | Combigan® | 0 | 120 | |
| serious | VIth nerve paralysis | Nervous system disorders | Alphagan® and Timolol Concurrent | 1 | 116 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Combigan® | ||
| Total, all-cause mortality | Alphagan® and Timolol Concurrent | ||
| Total, other adverse events | Combigan® | 0 | 120 |
| Total, other adverse events | Alphagan® and Timolol Concurrent | 0 | 116 |
| Total, serious adverse events | Combigan® | 1 | 120 |
| Total, serious adverse events | Alphagan® and Timolol Concurrent | 1 | 116 |
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 |
|---|
| Combigan® vs Alphagan® and Timolol Concurrent: 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/NCT01229462
GET https://conductscience.org/api/trials/v1/NCT01229462/registered