PGE2 Levels in Patient Treated With NSAIDs

Overview

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.

Full Title of Study: “Vitreous pge2 Level Changes After Topical Administration of Diclofenac 0.1%, Nepafenac 0.3%, Indomethacin 0.5% and Bromfenac 0.09% in Vitrectomy Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: July 5, 2018

Interventions

  • Other: Placebo
    • Artificial tears for 3 days preoperatively
  • Drug: Dicloftil
    • Dosing of drug 3 days prior to surgery
  • Drug: Nevanac
    • Dosing of drug 3 days prior to surgery
  • Drug: Indom
    • Dosing of drug 3 days prior to surgery
  • Drug: Yellox
    • Dosing of drug 3 days prior to surgery

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
    • Placebo using single-use vials of hyaluronic acid 0.2% preservative-free lubricating tear drops three days before surgery.
  • Experimental: Dicloftil
    • Diclofenac Na 0.1% Oph Soln, “Dicloftil®”, NSAID eyedrops administered three days before surgery
  • Experimental: Nevanac
    • Nepafenac 0.3% Ophthalmic Suspension, “Nevanac 3mg/ml®”, NSAID eyedrops administered three days before surgery
  • Experimental: Indom
    • Indomethacin 5 MG/ML Ophthalmic Suspension, “Indom ®”, NSAID eyedrops administered three days before surgery
  • Experimental: Yellox
    • Bromfenac 0.09 % Ophthalmic Solution, “Yellox®”, NSAID eyedrops administered three days before surgery

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 55 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Trieste
  • Provider of Information About this Clinical Study
    • Principal Investigator: Marco Rocco Pastore, Principal Investigator – University of Trieste
  • Overall Official(s)
    • Marco R Pastore, MD, Principal Investigator, Eye Clinic, Departement of Medical Surgical Sciences and Health, University of Trieste Trieste, TS, 34129, Italy

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