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NCT01736527 · ClinicalTrials.gov registry record · Phase 1
Tear Fluid Levels of Loteprednol Etabonate Ophthalmic Gel 0.5% Following a Single Instillation
A Phase 1 study, sponsored by Bausch & Lomb Incorporated.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT01736527: Completed Phase 1 study, sponsored by Bausch & Lomb Incorporated.
NCT01736527 is a Phase 1 study that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01736527, a Phase 1 study, has completed, sponsored by Bausch & Lomb Incorporated.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
To assess the levels of loteprednol etabonate (LE) in tear fluid following a single topical instillation of LE ophthalmic gel 0.5% formulation to healthy volunteers.
Primary Outcome
Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose
Interventions
- DRUG LE Gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2013-01 |
| Est. Completion | 2013-04 |
| Phase | Phase 1 |
What the finished NCT01736527 record still lists
NCT01736527 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which LE Gel is the first listed.
NCT01736527 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01736527 about?
NCT01736527 is a clinical study titled "Tear Fluid Levels of Loteprednol Etabonate Ophthalmic Gel 0.5% Following a Single Instillation". To assess the levels of loteprednol etabonate (LE) in tear fluid following a single topical instillation of LE ophthalmic gel 0.5% formulation to healthy volunteers.
What is the current status of trial NCT01736527?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2013-01. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01736527?
The interventions under investigation include: LE Gel (DRUG).
Who is sponsoring clinical trial NCT01736527?
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 NCT01736527's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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