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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01749930
The ClinicalTrials.gov registry entry for NCT01749930 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, above the 270-participant average among 54 other Ocular Hypertension trials with a reported enrollment target (56% higher). The listed sponsor is Bausch & Lomb Incorporated, which has 174 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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