Trial · NCT01646151
A Study Comparing IOP-Lowering Treatments to Bimatoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
NCT01646151, Completed, Allergan; results first posted 2014-06-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study Comparing IOP-Lowering Treatments to Bimatoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension. Trials, record NCT01646151. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01646151
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Comparing IOP-Lowering Treatments to Bimatoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
- NCT number
- NCT01646151
- Status
- Completed
- Enrollment
- 2,580 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Interventions
- Bimatoprost
- First posted
- 2012-07-20
- Last updated
- 2014-06-13
- Results first posted
- 2014-06-13
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Intraocular Pressure (IOP) at Baseline | Baseline | IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Baseline. |
| Primary | IOP at Week 12 | Week 12 | IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 12. |
| Secondary | Physician Evaluation of IOP Lowering in the Study Eye(s) | Week 12 | IOP is a measurement of the fluid pressure inside the eye. Physicians evaluated IOP compared to the target IOP for each patient's study eye(s). The numbers of eyes in each category are presented. |
| Secondary | Patient Assessment of Tolerability on a 4-Point Scale | Week 12 | Patient assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented. |
| Secondary | Physician Assessment of Tolerability on a 4-Point Scale | Week 12 | Physician assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented. |
| Secondary | Physician Assessment of Patient Compliance Compared to Previous Therapy | Week 12 | Physician assessment of patient compliance compared to previous therapy was assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented. |
| Secondary | Percentage of Patients Who Discontinue Treatment With Bimatoprost-Containing Eye Drops Prior to 12 Weeks of Treatment | 12 Weeks | Patients who discontinue treatment with bimatoprost-containing eye drops prior to 12 weeks of treatment was assessed as Yes or No. |
| Secondary | Percentage of Patients Who Continue Treatment With Bimatoprost-Containing Eye Drops | Week 12 | Patients who will continue treatment with bimatoprost-containing eye drops after 12 weeks of treatment was assessed as Yes or No. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Intraocular Pressure (IOP) at Baseline | Baseline | All patients with data for this outcome measure | Millimeters of Mercury (mmHg) | MEAN |
| SECONDARY | Physician Evaluation of IOP Lowering in the Study Eye(s) | Week 12 | All patients with data for this outcome measure | Eyes | NUMBER |
| SECONDARY | Patient Assessment of Tolerability on a 4-Point Scale | Week 12 | All patients with data for this outcome measure | Patients | NUMBER |
| SECONDARY | Physician Assessment of Tolerability on a 4-Point Scale | Week 12 | All patients with data for this outcome measure | Patients | NUMBER |
| SECONDARY | Physician Assessment of Patient Compliance Compared to Previous Therapy | Week 12 | All patients with data for this outcome measure | Patients | NUMBER |
| SECONDARY | Percentage of Patients Who Discontinue Treatment With Bimatoprost-Containing Eye Drops Prior to 12 Weeks of Treatment | 12 Weeks | All patients | Percentage of Patients | NUMBER |
| SECONDARY | Percentage of Patients Who Continue Treatment With Bimatoprost-Containing Eye Drops | Week 12 | All patients | Percentage of Patients | NUMBER |
| PRIMARY | IOP at Week 12 | Week 12 | All patients with data for this outcome measure | Millimeters of Mercury (mmHg) | MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Intraocular Pressure (IOP) at Baseline | Bimatoprost | Right Eye | 20.51 | Standard Deviation 4.32 | Millimeters of Mercury (mmHg) |
| Intraocular Pressure (IOP) at Baseline | Bimatoprost | Left Eye (n=2091) | 20.65 | Standard Deviation 4.54 | Millimeters of Mercury (mmHg) |
| Physician Evaluation of IOP Lowering in the Study Eye(s) | Bimatoprost | IOP lower than target | 622 | Eyes | |
| Physician Evaluation of IOP Lowering in the Study Eye(s) | Bimatoprost | Target IOP reached | 1173 | Eyes | |
| Physician Evaluation of IOP Lowering in the Study Eye(s) | Bimatoprost | IOP decreased but target not reached | 467 | Eyes | |
| Physician Evaluation of IOP Lowering in the Study Eye(s) | Bimatoprost | IOP increased | 85 | Eyes | |
| Physician Evaluation of IOP Lowering in the Study Eye(s) | Bimatoprost | No change | 119 | Eyes | |
| Physician Evaluation of IOP Lowering in the Study Eye(s) | Bimatoprost | Data Missing | 205 | Eyes | |
| Patient Assessment of Tolerability on a 4-Point Scale | Bimatoprost | Very Good | 1127 | Patients | |
| Patient Assessment of Tolerability on a 4-Point Scale | Bimatoprost | Good | 1070 | Patients |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bimatoprost | 2,580 | |
| Overall Study | COMPLETED | Bimatoprost | 2,410 | |
| Overall Study | NOT COMPLETED | Bimatoprost | 170 |
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 | 292 | 2,580 | |
| other | Eye Irritation | Eye disorders | Bimatoprost | 158 | 2,580 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bimatoprost | ||
| Total, other adverse events | Bimatoprost | 450 | 2,580 |
| Total, serious adverse events | Bimatoprost | 0 | 2,580 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01646151
GET https://conductscience.org/api/trials/v1/NCT01646151/results?page=2