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NSAIDs and PGE2 Levels in Vitrectomy Patients

Information source: UniversitÓ degli Studi di Brescia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vitreous Inflammation

Intervention: Ketorolac 0.5% eyedrops (Drug); Indomethacin 0.5% eyedrops (Drug); Bromfenac 0.09% eyedrops (Drug); Nepafenac 0.1% eyedrops (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: UniversitÓ degli Studi di Brescia

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).

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Prostaglandin E2 levels in the vitreous (pg/mL)

Secondary outcome:

NSAIDs concentration (ng/mL) into the vitreous

Adverse events

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- patients with pucker scheduled for vitrectomy

Exclusion Criteria:

- diabetes

- active inflammation

Locations and Contacts

Additional Information

Starting date: March 2014
Last updated: February 6, 2015

Page last updated: August 23, 2015

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