Trial · NCT01749904
Comparing Safety and Efficacy of BOL-303259-X With Timolol Maleate in Subjects With Open-Angle Glaucoma or Ocular Hypertension
NCT01749904, Phase 3, Completed, Bausch & Lomb Incorporated; results first posted 2018-11-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparing Safety and Efficacy of BOL-303259-X With Timolol Maleate in Subjects With Open-Angle Glaucoma or Ocular Hypertension. Trials, record NCT01749904. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01749904
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparing Safety and Efficacy of BOL-303259-X With Timolol Maleate in Subjects With Open-Angle Glaucoma or Ocular Hypertension
- NCT number
- NCT01749904
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 420 participants, actual
- Lead sponsor
- Bausch & Lomb Incorporated
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Interventions
- BOL-303259-X, Timolol, BOL-303259-X
- First posted
- 2012-12-17
- Last updated
- 2018-11-07
- Results first posted
- 2018-11-07
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean IOP | 8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3) | Mean intraocular pressure (IOP) in study eye measured at the specified time points: 8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3). |
| Secondary | Response Rate - IOP ≤ 18 mm Hg | 8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3). | Percentage of participants with IOP ≤ 18 mm Hg consistently at all 9 time points in the first 3 months |
| Secondary | Response Rate - IOP Reduction ≥ 25% | 8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3). | Percentage of participants with IOP reduction ≥ 25% consistently at all 9 time points in the first 3 months |
| Other | Number of Participants With Ocular and Systemic Adverse Events | 12 months | Following assessments through Visit 6 (Month 3), all participants, irrespective of previous randomization, converted to a single open label safety arm receiving BOL-303259-X QD in the evening. Adverse events were recorded throughout the comparative efficacy phase and open label extension phase. |
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 | Mean IOP | 8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3) | Intent-to-treat population with LOCF | mm Hg | LEAST_SQUARES_MEAN |
| SECONDARY | Response Rate - IOP ≤ 18 mm Hg | 8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3). | Intent-to-treat population with LOCF | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Response Rate - IOP Reduction ≥ 25% | 8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3). | Intent-to-treat with LOCF | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With Ocular and Systemic Adverse Events | 12 months | Safety population (analyzed as treated). Of the 420 subjects randomized, 418 instilled at least one dose of study medication and were included in the safety population; one subject randomized to BOL-303259-X received timolol in the efficacy phase and was therefore analyzed as part of the timolol treatment group. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean IOP | BOL-303259-X | 8 am week 2 | 18.61 | Standard Deviation 3.544 | mm Hg |
| Mean IOP | Timolol | 8 am week 2 | 19.84 | Standard Deviation 3.651 | mm Hg |
| Mean IOP | BOL-303259-X | 12 pm week 2 | 18.00 | Standard Deviation 3.376 | mm Hg |
| Mean IOP | Timolol | 12 pm week 2 | 19.37 | Standard Deviation 3.696 | mm Hg |
| Mean IOP | BOL-303259-X | 4 pm week 2 | 18.09 | Standard Deviation 3.293 | mm Hg |
| Mean IOP | Timolol | 4 pm week 2 | 19.20 | Standard Deviation 3.359 | mm Hg |
| Mean IOP | BOL-303259-X | 8 am week 6 | 18.59 | Standard Deviation 3.525 | mm Hg |
| Mean IOP | Timolol | 8 am week 6 | 19.63 | Standard Deviation 3.243 | mm Hg |
| Mean IOP | BOL-303259-X | 12 pm week 6 | 17.84 | Standard Deviation 3.305 | mm Hg |
| Mean IOP | Timolol | 12 pm week 6 | 19.09 | Standard Deviation 3.230 | mm Hg |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BOL-303259-X | 286 | |
| Overall Study | STARTED | Timolol | 134 | |
| Overall Study | COMPLETED | BOL-303259-X | 264 | |
| Overall Study | COMPLETED | Timolol | 123 | |
| Overall Study | NOT COMPLETED | BOL-303259-X | 22 | |
| Overall Study | NOT COMPLETED | Timolol | 11 |
Source ClinicalTrials.gov
Adverse events51
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 | Eye irritation | Eye disorders | BOL-303259-X | 11 | 283 | |
| other | Eye irritation | Eye disorders | Timolol | 3 | 135 | |
| other | Eye irritation | Eye disorders | BOL-303259-X Safety Extension Phase | 5 | 385 | |
| serious | torn rotator cuff | Musculoskeletal and connective tissue disorders | BOL-303259-X | 0 | 283 | 0 |
| serious | torn rotator cuff | Musculoskeletal and connective tissue disorders | Timolol | 1 | 135 | 1 |
| serious | torn rotator cuff | Musculoskeletal and connective tissue disorders | BOL-303259-X Safety Extension Phase | 0 | 385 | 0 |
| serious | Chest pain | Respiratory, thoracic and mediastinal disorders | BOL-303259-X | 1 | 283 | 1 |
| serious | Chest pain | Respiratory, thoracic and mediastinal disorders | Timolol | 0 | 135 | 0 |
| serious | Chest pain | Respiratory, thoracic and mediastinal disorders | BOL-303259-X Safety Extension Phase | 0 | 385 | 0 |
| serious | Pneumonia | Infections and infestations | BOL-303259-X | 0 | 283 | 0 |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BOL-303259-X | ||
| Total, all-cause mortality | Timolol | ||
| Total, all-cause mortality | BOL-303259-X Safety Extension Phase | ||
| Total, other adverse events | BOL-303259-X | 11 | 283 |
| Total, other adverse events | Timolol | 3 | 135 |
| Total, other adverse events | BOL-303259-X Safety Extension Phase | 5 | 385 |
| Total, serious adverse events | BOL-303259-X | 3 | 283 |
| Total, serious adverse events | Timolol | 2 | 135 |
| Total, serious adverse events | BOL-303259-X Safety Extension Phase | 8 | 385 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| BOL-303259-X vs Timolol: Response Rate - IOP Reduction ≥ 25% | Trial comparisons |
| BOL-303259-X vs Timolol: Response Rate - IOP ≤ 18 mm Hg | 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/NCT01749904
GET https://conductscience.org/api/trials/v1/NCT01749904/results?page=2