NSAIDs and PGE2 Levels in Vitrectomy Patients

February 6, 2015 updated by: Andrea Russo, Università degli Studi di Brescia

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with pucker scheduled for vitrectomy

Exclusion Criteria:

  • diabetes
  • active inflammation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
No NSAIDs were administered prior to surgery
Experimental: Ketorolac eyedrops
Ketorolac 0.5% eyedrops were administered prior to surgery
Drug: Ketorolac 0.5% eyedrops
Experimental: Indomethacin eyedrops
Indomethacin 0.5% eyedrops were administered prior to surgery
Drug: Indomethacin 0.5% eyedrops
Experimental: Nepafenac eyedrops
Nepafenac 0.1% eyedrops were administered prior to surgery
Drug: Nepafenac 0.1% eyedrops
Experimental: Bromfenac eyedrops
Bromfenac 0.09% eyedrops were administered prior to surgery
Drug: Bromfenac 0.09% eyedrops

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prostaglandin E2 levels in the vitreous (pg/mL)
Time Frame: 7 days after NSAID TID administration, following vitrectomy
7 days after NSAID TID administration, following vitrectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NSAIDs concentration (ng/mL) into the vitreous
Time Frame: 7 days after NSAID TID administration, following vitrectomy
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
Adverse events
Time Frame: 7 days after NSAID TID administration, following vitrectomy
7 days after NSAID TID administration, following vitrectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi di Brescia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

January 27, 2015

First Submitted That Met QC Criteria

February 6, 2015

First Posted (Estimate)

February 12, 2015

Study Record Updates

Last Update Posted (Estimate)

February 12, 2015

Last Update Submitted That Met QC Criteria

February 6, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vitreo001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vitreous Inflammation

Clinical Trials on Ketorolac 0.5% eyedrops

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe