Phase 3
N=326
Loteprednol Etabonate Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Inflammation · Pain · Cataract
Bottom Line
View on ClinicalTrials.gov: NCT02208297 ↗Enrolled (actual)
326
Serious AEs
0.3%
Results posted
Sep 2020
Primary outcome: Primary: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells — 38; 29 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Loteprednol Etabonate Gel (BID) (Drug); Vehicle Gel (BID) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells |
38; 29 | — |
| PRIMARY Percentage of Participants With Grade 0 Pain in the Study Eye. |
120; 97 | — |
| SECONDARY Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit |
16; 11; 82; 57; 80; 67 | — |
| SECONDARY Percentage of Participants With Grade 0 Pain in the Study Eye by Visit. |
106; 87; 132; 95; 122; 91 | — |
| SECONDARY Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye by Visit. |
96; 71; 114; 81; 131; 100 | — |
| SECONDARY Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and AC Flare in the Study Eye by Visit. |
15; 9; 37; 29; 80; 56 | — |
Summary
The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate (LE) ophthalmic gel, 0.38% (BID)
Eligibility Criteria
Inclusion Criteria
Visit 1 (Screening Visit)
- Be willing and able to comply with all treatment and follow-up/study procedures.
- Be a candidate for routine, uncomplicated cataract surgery.
Visit 3 (Postoperative Day 1)
- Have undergone routine, uncomplicated cataract surgery (phaco-emulsification with posterior chamber intraocular lens (IOL) implantation, not combined with any other surgery) in the study eye.
- Have ≥ Grade 2 anterior chamber (AC) cells (6-15 cells) in the study eye.
Exclusion Criteria
- Have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.
- Have known hypersensitivity or contraindication to the study drug(s) or their components.
Data sourced from ClinicalTrials.gov (NCT02208297). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.