drugset / Trial / NCT02361645

NSAIDs and PGE2 Levels in Vitrectomy Patients

NCT02361645

Phase 3 Completed 70 enrolled University of Brescia
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to assess vitreous concentrations of nonsteroidal antiinflammatory drugs (NSAIDs) and prostaglandin E2 in patients treated with NSAIDs before vitrectomy. A total of 0.5 to 1 mL undiluted vitreous was removed from the midvitreous cavity at the beginning of the surgery before infusion with balanced salt solution. Samples were immediately frozen and stored at -40°C until analysis. Samples were evaluated in a masked fashion. Vitreous concentrations of the study drugs were quantified using a reverse-phase liquid chromatography mass spectroscopy system. The minimum quantification limit for ketorolac, bromfenac, nepafenac, and amfenac was 0.8 ng/mL. Prostaglandin E2 concentrations were determined using a commercially available competitive enzyme immunoassay kit (R \& D Systems, Minneapolis, MN).

Timeline

Start
2014-03
Primary completion
2014-11
Completion
2015-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Bromfenac Other / unclassified 0.09 % Topical
Subject Indomethacin Small molecule 0.5 % Topical
Subject Ketorolac Other / unclassified 0.5 % Topical
Subject Nepafenac Other / unclassified 0.1 % Topical

Indications