Loteprednol Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract S… (NCT01996839) | Clinical Trial Compass
CompletedPhase 3
Loteprednol Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
United States514 participantsStarted 2013-12
Plain-language summary
The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate ophthalmic gel
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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.