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NCT01163643 · ClinicalTrials.gov registry record · Phase 2
Study to Assess the Safety and Efficacy of BOL-303242-X Ophthalmic Suspension in Dry Eye Syndrome
A Phase 2 study, sponsored by Bausch & Lomb Incorporated.
- Completed
- Registry status
- Phase 2
- Development phase
- 356
- Enrollment target
NCT01163643: Completed Phase 2 study, sponsored by Bausch & Lomb Incorporated.
NCT01163643 is a Phase 2 study that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 356 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (168% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01163643, a Phase 2 study, has completed, sponsored by Bausch & Lomb Incorporated.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 356 participants
- Enrollment target
Study Summary
The objective of this study is to identify the concentration and daily dosing frequency of BOL-303242-X ophthalmic suspension in treating dry eye syndrome over a 12 week dosing period.
Primary Outcome
Total corneal staining score was calculated by adding the individual grades from 5 regions of the corneal surface (1: Central; 2: Superior; 3: Temporal; 4: Nasal; 5: Inferior). Grade 0 = none and Grade 3 = severe. The minimum total score possible was 0 and the maximum total score possible was 15. Higher scores indicated worse outcome.
Interventions
- DRUG Placebo Comparator: Vehicle
- DRUG 0.3% BOL-303242-X ophthalmic suspension
- DRUG 2% BOL-303242-X ophthalmic suspension
- DRUG 1% BOL-303242-X ophthalmic suspension
- DRUG 2% BOL-303242-X ophthalmic suspension AM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 356 participants |
| Start Date | 2010-07 |
| Est. Completion | 2011-07 |
| Phase | Phase 2 |
What the finished NCT01163643 record still lists
NCT01163643 is an interventional study that assigns participants to a tested intervention. The registered 356 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (168% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo Comparator: Vehicle is the first listed.
NCT01163643 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01163643 about?
NCT01163643 is a clinical study titled "Study to Assess the Safety and Efficacy of BOL-303242-X Ophthalmic Suspension in Dry Eye Syndrome". The objective of this study is to identify the concentration and daily dosing frequency of BOL-303242-X ophthalmic suspension in treating dry eye syndrome over a 12 week dosing period.
What is the current status of trial NCT01163643?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 356 participants. The study started on 2010-07. Estimated completion is 2011-07.
What interventions are being tested in trial NCT01163643?
The interventions under investigation include: Placebo Comparator: Vehicle (DRUG), 0.3% BOL-303242-X ophthalmic suspension (DRUG), 2% BOL-303242-X ophthalmic suspension (DRUG), 1% BOL-303242-X ophthalmic suspension (DRUG), 2% BOL-303242-X ophthalmic suspension AM (DRUG).
Who is sponsoring clinical trial NCT01163643?
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 NCT01163643's enrollment target sits among peer trials
356 128th of 2000 higher than 1,873 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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