Trial · NCT01068964
Safety and Efficacy of Bimatoprost Timolol Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension
NCT01068964, Not applicable, Completed, Allergan; results first posted 2012-01-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Bimatoprost Timolol Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension. Trials, record NCT01068964. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01068964
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Bimatoprost Timolol Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension
- NCT number
- NCT01068964
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 235 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Interventions
- 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution, 0.03% Bimatoprost Ophthalmic Solution and 0.5% Timolol Ophthalmic Solution
- First posted
- 2010-02-17
- Last updated
- 2019-04-17
- Results first posted
- 2012-01-20
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Difference of Change From Baseline of Mean Diurnal Intraocular Pressure (IOP) Between the Two Treatment Groups at Week 4 | Baseline, Week 4 | The difference of change from baseline of mean diurnal IOP between the 0.03% Bimatoprost/0.5% Timolol in Same Bottle and the 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles at week 4. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of the study eye (the eye with the highest IOP at baseline) over the 3 time points measured at 8AM, 12PM and 4PM. A negative number change from baseline indicated a reduction (improvement) in IOP. The difference of change from baseline in IOP is presented in the statistical analysis section. |
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 | The Difference of Change From Baseline of Mean Diurnal Intraocular Pressure (IOP) Between the Two Treatment Groups at Week 4 | Baseline, Week 4 | Intent to Treatment population defined as all patients randomized. One patient in the 0.03% Bimatoprost/0.5% Timolol in Same Bottle group was not included in the analysis. | Millimeters of mercury (mmHg) | 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 |
|---|---|---|---|---|---|
| The Difference of Change From Baseline of Mean Diurnal Intraocular Pressure (IOP) Between the Two Treatment Groups at Week 4 | 0.03% Bimatoprost/0.5% Timolol in Same Bottle | Baseline | 25.20 | Standard Deviation 3.06 | Millimeters of mercury (mmHg) |
| The Difference of Change From Baseline of Mean Diurnal Intraocular Pressure (IOP) Between the Two Treatment Groups at Week 4 | 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles | Baseline | 24.87 | Standard Deviation 3.88 | Millimeters of mercury (mmHg) |
| The Difference of Change From Baseline of Mean Diurnal Intraocular Pressure (IOP) Between the Two Treatment Groups at Week 4 | 0.03% Bimatoprost/0.5% Timolol in Same Bottle | Change from Baseline at Week 4 | -9.38 | Standard Deviation 4.66 | Millimeters of mercury (mmHg) |
| The Difference of Change From Baseline of Mean Diurnal Intraocular Pressure (IOP) Between the Two Treatment Groups at Week 4 | 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles | Change from Baseline at Week 4 | -8.93 | Standard Deviation 4.25 | Millimeters of mercury (mmHg) |
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 | 0.03% Bimatoprost/0.5% Timolol in Same Bottle | 121 | |
| Overall Study | STARTED | 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles | 114 | |
| Overall Study | COMPLETED | 0.03% Bimatoprost/0.5% Timolol in Same Bottle | 113 | |
| Overall Study | COMPLETED | 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles | 104 | |
| Overall Study | NOT COMPLETED | 0.03% Bimatoprost/0.5% Timolol in Same Bottle | 8 | |
| Overall Study | NOT COMPLETED | 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles | 10 |
Source ClinicalTrials.gov
Adverse events8
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 | 0.03% Bimatoprost/0.5% Timolol in Same Bottle | 26 | 121 | |
| other | Conjunctival hyperaemia | Eye disorders | 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles | 21 | 114 | |
| other | Eye pain | Eye disorders | 0.03% Bimatoprost/0.5% Timolol in Same Bottle | 4 | 121 | |
| other | Eye pain | Eye disorders | 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles | 8 | 114 | |
| serious | Goitre | Endocrine disorders | 0.03% Bimatoprost/0.5% Timolol in Same Bottle | 0 | 121 | |
| serious | Goitre | Endocrine disorders | 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles | 1 | 114 | |
| serious | Ocular hypertension | Eye disorders | 0.03% Bimatoprost/0.5% Timolol in Same Bottle | 0 | 121 | |
| serious | Ocular hypertension | Eye disorders | 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles | 1 | 114 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 0.03% Bimatoprost/0.5% Timolol in Same Bottle | ||
| Total, all-cause mortality | 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles | ||
| Total, other adverse events | 0.03% Bimatoprost/0.5% Timolol in Same Bottle | 30 | 121 |
| Total, other adverse events | 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles | 29 | 114 |
| Total, serious adverse events | 0.03% Bimatoprost/0.5% Timolol in Same Bottle | 0 | 121 |
| Total, serious adverse events | 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles | 2 | 114 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24571886 | 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 |
|---|
| 0.03% Bimatoprost/0.5% Timolol in Same Bottle vs 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles: 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/NCT01068964
GET https://conductscience.org/api/trials/v1/NCT01068964/registered