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NCT01996839 · ClinicalTrials.gov registry record · Phase 3
Loteprednol 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
- 514
- Enrollment target
NCT01996839: Completed Phase 3 study, sponsored by Bausch & Lomb Incorporated.
NCT01996839 is a Phase 3 study that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 514 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01996839, a Phase 3 study, has completed, sponsored by Bausch & Lomb Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 514 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate ophthalmic gel
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 Loteprednol Etabonate Gel (TID)
- DRUG Vehicle (BID)
- DRUG Vehicle (TID)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 514 participants |
| Start Date | 2013-12 |
| Est. Completion | 2014-07 |
| Phase | Phase 3 |
What the finished NCT01996839 record still lists
NCT01996839 is an interventional study that assigns participants to a tested intervention. The registered 514 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 (33% lower).
The record links to 0 conditions, and to 4 interventions - of which Loteprednol Etabonate Gel (BID) is the first listed.
NCT01996839 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01996839 about?
NCT01996839 is a clinical study titled "Loteprednol 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 ophthalmic gel
What is the current status of trial NCT01996839?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 514 participants. The study started on 2013-12. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01996839?
The interventions under investigation include: Loteprednol Etabonate Gel (BID) (DRUG), Loteprednol Etabonate Gel (TID) (DRUG), Vehicle (BID) (DRUG), Vehicle (TID) (DRUG).
Who is sponsoring clinical trial NCT01996839?
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 NCT01996839's enrollment target sits among peer trials
514 724th of 2000 higher than 1,274 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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