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PGE2 Levels in Patient Treated With NSAIDs

NCT03597867 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2018-07-24

No results posted yet for this study

Summary

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.

Conditions

  • Ocular Inflammation

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

Sponsors & Collaborators

  • University of Trieste

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-25
Primary Completion
2018-07-05
Completion
2018-07-09

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03597867 on ClinicalTrials.gov