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NCT02208297 · ClinicalTrials.gov registry record · Phase 3
Loteprednol Etabonate Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
A Phase 3 study, sponsored by Bausch & Lomb Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 326
- Enrollment target
NCT02208297: Completed Phase 3 study, sponsored by Bausch & Lomb Incorporated.
NCT02208297 is a Phase 3 study that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 326 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02208297, a Phase 3 study, has completed, sponsored by Bausch & Lomb Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 326 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate (LE) ophthalmic gel, 0.38% (BID)
Primary Outcome
White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = \> 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye.
Interventions
- DRUG Loteprednol Etabonate Gel (BID)
- DRUG Vehicle Gel (BID)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 326 participants |
| Start Date | 2014-09 |
| Est. Completion | 2015-03 |
| Phase | Phase 3 |
What the finished NCT02208297 record still lists
NCT02208297 is an interventional study that assigns participants to a tested intervention. The registered 326 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 (58% lower).
The record links to 0 conditions, and to 2 interventions - of which Loteprednol Etabonate Gel (BID) is the first listed.
NCT02208297 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02208297 about?
NCT02208297 is a clinical study titled "Loteprednol Etabonate Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery". The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate (LE) ophthalmic gel, 0.38% (BID)
What is the current status of trial NCT02208297?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 326 participants. The study started on 2014-09. Estimated completion is 2015-03.
What interventions are being tested in trial NCT02208297?
The interventions under investigation include: Loteprednol Etabonate Gel (BID) (DRUG), Vehicle Gel (BID) (DRUG).
Who is sponsoring clinical trial NCT02208297?
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 NCT02208297's enrollment target sits among peer trials
326 1075th of 2000 higher than 925 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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