PGE2 Levels in Patient Treated With NSAIDs

July 21, 2018 updated by: Marco Rocco Pastore, University of Trieste

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • TS
      • Trieste, TS, Italy, 34129
        • Eye Clinic, Departement of Medical Surgical Sciences and Health, University of Trieste

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

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • epiretinal membrane or full thickness macular hole scheduled for vitrectomy

Exclusion Criteria:

  • vitreous hemorrhage
  • diabetes
  • glaucoma
  • concurrent retinovascular disease
  • previous ocular inflammation
  • previous ocular surgery
  • history of ocular trauma
  • previuos intravitreal injections
  • concomitant intake of topical or systemic NSAIDs or corticosteroid therapy

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
Placebo Comparator: Placebo
Placebo using single-use vials of hyaluronic acid 0.2% preservative-free lubricating tear drops three days before surgery.
Other: Placebo
Artificial tears for 3 days preoperatively
Other Names:
  • Tears
Experimental: Dicloftil
Diclofenac Na 0.1% Oph Soln, "Dicloftil®", NSAID eyedrops administered three days before surgery
Drug: Dicloftil
Dosing of drug 3 days prior to surgery
Other Names:
  • Diclofenac Na 0.1% Oph Soln
Experimental: Nevanac
Nepafenac 0.3% Ophthalmic Suspension, "Nevanac 3mg/ml®", NSAID eyedrops administered three days before surgery
Drug: Nevanac
Dosing of drug 3 days prior to surgery
Other Names:
  • Nepafenac 0.3% Ophthalmic Suspension
Experimental: Indom
Indomethacin 5 MG/ML Ophthalmic Suspension, "Indom ®", NSAID eyedrops administered three days before surgery
Drug: Indom
Dosing of drug 3 days prior to surgery
Other Names:
  • Indomethacin 5 MG/ML Ophthalmic Suspension
Experimental: Yellox
Bromfenac 0.09 % Ophthalmic Solution, "Yellox®", NSAID eyedrops administered three days before surgery
Drug: Yellox
Dosing of drug 3 days prior to surgery
Other Names:
  • Bromfenac 0.09 % Ophthalmic Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Vitreous NSAIDs and PGE2 levels
Time Frame: 3 days after topical NSAID administration
3 days after topical NSAID administration

Collaborators and Investigators

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

Sponsor

University of Trieste

Investigators

  • Principal Investigator: Marco R Pastore, MD, Eye Clinic, Departement of Medical Surgical Sciences and Health, University of Trieste Trieste, TS, 34129, Italy

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 (Actual)

April 25, 2018

Primary Completion (Actual)

July 5, 2018

Study Completion (Actual)

July 9, 2018

Study Registration Dates

First Submitted

July 11, 2018

First Submitted That Met QC Criteria

July 21, 2018

First Posted (Actual)

July 24, 2018

Study Record Updates

Last Update Posted (Actual)

July 24, 2018

Last Update Submitted That Met QC Criteria

July 21, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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