Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01749930 · ClinicalTrials.gov registry record · Phase 3
Comparing the Safety and Efficacy of BOL-303259-X Ophthalmic Solution With Timolol Maleate Ophthalmic Solution in Subjects With Open-Angle Glaucoma or Ocular Hypertension
A Phase 3 study of Ocular Hypertension and Open Angle Glaucoma, sponsored by Bausch & Lomb Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 420
- Enrollment target
- 1
- Study location
NCT01749930: Completed Phase 3 study of Ocular Hypertension and Open Angle Glaucoma, sponsored by Bausch & Lomb Incorporated.
NCT01749930 is a Phase 3 study of Ocular Hypertension and Open Angle Glaucoma that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 420 participants, above the 270-participant average among 54 other Ocular Hypertension trials with a reported enrollment target (56% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01749930, a Phase 3 study of Ocular Hypertension and Open Angle Glaucoma, has completed, sponsored by Bausch & Lomb Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 420 participants
- Enrollment target
- 1
- Study location
Study Summary
In participants with a diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT), the primary objective is to demonstrate that the mean IOP reduction after 3 months of treatment with BOL-303259-X once daily (QD) is non-inferior to timolol maleate 0.5% twice daily (BID). The secondary objective is to demonstrate the superiority of BOL-303259-X QD to timolol maleate 0.5% BID. This assessment will be performed if the non-inferiority of BOL-303259-X QD to timolol maleate 0.5% BID is determined. An open label safety phase will be conducted at the end of Visit 6 (3 months) where all participants will receive BOL-303259-X QD for an additional 3 months.
Primary Outcome
Mean intraocular pressure (IOP) in the 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).
Conditions Studied
Interventions
- DRUG Timolol
- DRUG BOL-303259-X
Study Locations (1)
New York
- Bausch & Lomb Inc. - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2013-01 |
| Est. Completion | 2015-05 |
| Phase | Phase 3 |
What the finished NCT01749930 record still lists
NCT01749930 is an interventional study that assigns participants to a tested intervention. The registered 420 participants enrollment target is mid-sized for trials with a published cap, above the 270-participant average among 54 other Ocular Hypertension trials with a reported enrollment target (56% higher).
The record links to 2 conditions, with Ocular Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Timolol is the first listed.
NCT01749930 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01749930 about?
NCT01749930 is a clinical study titled "Comparing the Safety and Efficacy of BOL-303259-X Ophthalmic Solution With Timolol Maleate Ophthalmic Solution in Subjects With Open-Angle Glaucoma or Ocular Hypertension". In participants with a diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT), the primary objective is to demonstrate that the mean IOP reduction after 3 months of treatment with BOL-303259-X once daily (QD) is non-inferior to timolol maleate 0.5% twice daily (BID). The secondary objec...
What is the current status of trial NCT01749930?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 420 participants. The study started on 2013-01. Estimated completion is 2015-05.
What conditions does trial NCT01749930 study?
This clinical trial studies the following conditions: Ocular Hypertension, Open Angle Glaucoma.
What interventions are being tested in trial NCT01749930?
The interventions under investigation include: Timolol (DRUG), BOL-303259-X (DRUG).
Who is sponsoring clinical trial NCT01749930?
This trial is sponsored by Bausch & Lomb Incorporated, which has 174 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01749930 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ocular Hypertension
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01749930's enrollment target sits among peer trials
420 15th of 54 higher than 40 of 54 other Ocular Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ocular Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Bioequivalence Study With Clinical Endpoint Comparing Bimatoprost Ophthalmic Solution 0.01% and LUMIGAN® in the Treatment of Chronic Open-Angle Glaucoma or Ocular Hypertension in Both Eyes.
RECRUITING · Phase 3
-
Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhine)
RECRUITING · Phase 3
-
Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhone)
RECRUITING · Phase 3
-
Reformulated PG324 Ophthalmic Solution for Intraocular Pressure Reduction
ACTIVE NOT RECRUITING · Phase 3
-
Long-term Safety and Efficacy Extension Trial of Bimatoprost SR
ACTIVE NOT RECRUITING · Phase 3
-
Evaluation of Safety of SPARC0913 in Open Angle Glaucoma or Ocular Hypertension
COMPLETED · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01790152 · 420 participants
Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment
- NCT02701244 · 420 participants
A Registry Study of Breast Microseed Treatment
- NCT02966665 · 420 participants · Phase 1
: Vascular Function in Health and Disease
- NCT04149743 · 420 participants · NA
HEMOTAG® Assessment for Short-term Outcomes of Heart Failure
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia