NCT03597867

PGE2 Levels in Patient Treated With NSAIDs

Vitreous pge2 Level Changes After Topical Administration of Diclofenac 0.1%, Nepafenac 0.3%, Indomethacin 0.5% and Bromfenac 0.09% in Vitrectomy Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: University of Trieste · Academic / Other
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ocular Inflammation

Interventions

Type	Name	Description
OTHER	Placebo	Artificial tears for 3 days preoperatively
DRUG	Dicloftil	Dosing of drug 3 days prior to surgery
DRUG	Nevanac	Dosing of drug 3 days prior to surgery
DRUG	Indom	Dosing of drug 3 days prior to surgery
DRUG	Yellox	Dosing of drug 3 days prior to surgery

Timeline

• Start date: 2018-04-25
• Primary completion: 2018-07-05
• Completion: 2018-07-09
• First posted: 2018-07-24
• Last updated: 2018-07-24

Locations

1 site across 1 country: Italy