Loteprednol Etabonate Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following … (NCT02208297) | Clinical Trial Compass
CompletedPhase 3
Loteprednol Etabonate Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
United States326 participantsStarted 2014-09
Plain-language summary
The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate (LE) ophthalmic gel, 0.38% (BID)
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells
Timeframe: 8 days
2
Percentage of Participants With Grade 0 Pain in the Study Eye.