drugset / Trial / NCT03597867

PGE2 Levels in Patient Treated With NSAIDs

NCT03597867

Phase 3 Completed 104 enrolled University of Trieste
RandomizedParallel-groupTriple-blindTreatment

Summary

The aim of this study is to determine vitreous levels of nonsteroidal antinflammatory drugs (NSAIDs) and prostaglandinE2 (PGE2) in eyes scheduled for vitrectomy. All patients received the study drugs for 3 days before surgery. 0.5 to 1.0 mL of undiluted vitreous was removed using the vitreous cutter positioned in the midvitreous cavity. Samples were immediately frozen and stored at -80°C until analysis. Sample analyses were performed using an high-performance liquid chromatography system. The lower limit of quantitation was 0.8 ng/mL. PGE2 levels were analyzed using the Prostaglandin E2 Monoclonal EIA Kit (Cayman Chemical Company) according to the manufacturer's instructions.

Timeline

Start
2018-04-25
Primary completion
2018-07-05
Completion
2018-07-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Bromfenac Other / unclassified 0.09 % Topical
Subject Diclofenac Other / unclassified 0.1 % Topical
Subject Indomethacin Small molecule 5 mg/ml Topical
Subject Nepafenac Other / unclassified 0.3 % Topical

Indications

No indication recorded.