PGE2 Levels in Patient Treated With NSAIDs

Sponsor

University of Trieste (Other)

Overall Status

Completed

CT.gov ID

NCT03597867

Collaborator

(none)

104

Enrollment

Location

Arms

2.5

Actual Duration (Months)

42.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Ocular Inflammation	Other: Placebo Drug: Dicloftil Drug: Nevanac Drug: Indom Drug: Yellox	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

104 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 25, 2018

Actual Primary Completion Date :

Jul 5, 2018

Actual Study Completion Date :

Jul 9, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Vitreous NSAIDs and PGE2 levels [3 days after topical NSAID administration]

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eye Clinic, Departement of Medical Surgical Sciences and Health, University of Trieste	Trieste	TS	Italy	34129

Sponsors and Collaborators

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