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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 is a Phase 3 study that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 420 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01749904
The ClinicalTrials.gov registry entry for NCT01749904 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 420 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch & Lomb Incorporated, which has 174 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Timolol is the first listed.
NCT01749904 reports 0 study locations.
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.
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