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NCT01749904 · ClinicalTrials.gov registry record · Phase 3
Comparing Safety and Efficacy of BOL-303259-X With Timolol Maleate in Subjects With Open-Angle Glaucoma or Ocular Hypertension
A Phase 3 study, sponsored by Bausch & Lomb Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 420
- Enrollment target
NCT01749904: Completed Phase 3 study, sponsored by Bausch & Lomb Incorporated.
NCT01749904 is a Phase 3 study that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 420 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01749904, a Phase 3 study, has completed, sponsored by Bausch & Lomb Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 420 participants
- Enrollment target
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 9 months.
Primary Outcome
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).
Interventions
- DRUG Timolol
- DRUG BOL-303259-X
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2013-01-31 |
| Est. Completion | 2015-09-30 |
| Phase | Phase 3 |
What the finished NCT01749904 record still lists
NCT01749904 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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower).
The record links to 0 conditions, and to 2 interventions - of which Timolol is the first listed.
NCT01749904 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01749904 about?
NCT01749904 is a clinical study titled "Comparing Safety and Efficacy of BOL-303259-X With Timolol Maleate 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 NCT01749904?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 420 participants. The study started on 2013-01-31. Estimated completion is 2015-09-30.
What interventions are being tested in trial NCT01749904?
The interventions under investigation include: Timolol (DRUG), BOL-303259-X (DRUG).
Who is sponsoring clinical trial NCT01749904?
This trial is sponsored by Bausch & Lomb Incorporated, which has 174 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01749904's enrollment target sits among peer trials
420 891st of 2000 higher than 1,102 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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