NSAIDs and PGE2 Levels in Vitrectomy Patients

Vitreous Inflammation Clinical Trial

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%

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02361645
• Other study ID #: Vitreo001
• Status: Completed
• Phase: Phase 3
• First received: January 27, 2015
• Last updated: February 6, 2015
• Start date: March 2014
• Est. completion date: January 2015

Study information

• Verified date: February 2015
• Source: Università degli Studi di Brescia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ethics Committee: Italy
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with pucker scheduled for vitrectomy

Exclusion Criteria:

• diabetes

• active inflammation

Study Design

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

Related Conditions & MeSH terms

• Inflammation
• Vitreous Inflammation

Intervention

Drug:
• Ketorolac 0.5% eyedrops

• Indomethacin 0.5% eyedrops

• Bromfenac 0.09% eyedrops

• Nepafenac 0.1% eyedrops

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Brescia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prostaglandin E2 levels in the vitreous (pg/mL)		7 days after NSAID TID administration, following vitrectomy	No
Secondary	NSAIDs concentration (ng/mL) into the vitreous	Vitreous concentrations of the study drugs were quantified using a reverse phase high performance liquid chromatography mass spectroscopy system.	7 days after NSAID TID administration, following vitrectomy	No
Secondary	Adverse events		7 days after NSAID TID administration, following vitrectomy	Yes