NCT02361645

NSAIDs and PGE2 Levels in Vitrectomy Patients

Vitreous Nonsteroidal Antiinflammatory Drus Concentrations And Prostaglandin E2 Levels in Vitrectomy Patients Treated With Indomethacin 0.5%, Bromfenac 0.09%, and Nepafenac 0.1%

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Università degli Studi di Brescia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Vitreous Inflammation

Interventions

Type	Name	Description
DRUG	Ketorolac 0.5% eyedrops
DRUG	Indomethacin 0.5% eyedrops
DRUG	Bromfenac 0.09% eyedrops
DRUG	Nepafenac 0.1% eyedrops

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-11-01
• Completion: 2015-01-01
• First posted: 2015-02-12
• Last updated: 2015-02-12