Phase 3
N=514
Loteprednol Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Inflammation · Pain · Cataract
Bottom Line
View on ClinicalTrials.gov: NCT01996839 ↗Enrolled (actual)
514
Serious AEs
0.4%
Results posted
Sep 2020
Primary outcome: Primary: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells — 16; 46; 49 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Loteprednol Etabonate Gel (BID) (Drug); Loteprednol Etabonate Gel (TID) (Drug); Vehicle (BID) (Drug); Vehicle (TID) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells |
16; 46; 49 | — |
| PRIMARY Percentage of Participants With Grade 0 Pain in the Study Eye. |
82; 126; 125 | — |
| SECONDARY Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit |
12; 13; 7; 28; 73; 83 | — |
| SECONDARY Percentage of Participants With Grade 0 Pain in the Study Eye by Visit. |
96; 123; 117; 81; 129; 137 | — |
| SECONDARY Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye by Visit. |
78; 95; 90; 71; 117; 122 | — |
| SECONDARY Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and AC Flare in the Study Eye by Visit. |
11; 12; 7; 16; 45; 47 | — |
Summary
The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate ophthalmic gel
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 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 (NCT01996839). 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.