PGE2 Levels in Patient Treated With NSAIDs

University of Trieste

Status and phase: Completed; Phase 3

Conditions: Ocular Inflammation

Treatments: Other: Placebo; Drug: Yellox; Drug: Indom; Drug: Nevanac; Drug: Dicloftil

Study type: Interventional

Funder types: Other

Identifiers

NCT03597867

02/2017

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: All

Ages: 55 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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104 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo using single-use vials of hyaluronic acid 0.2% preservative-free lubricating tear drops three days before surgery.

Treatment:

Other: Placebo

Dicloftil

Experimental group

Description:

Diclofenac Na 0.1% Oph Soln, "Dicloftil®", NSAID eyedrops administered three days before surgery

Treatment:

Drug: Dicloftil

Nevanac

Experimental group

Description:

Nepafenac 0.3% Ophthalmic Suspension, "Nevanac 3mg/ml®", NSAID eyedrops administered three days before surgery

Treatment:

Drug: Nevanac

Indom

Experimental group

Description:

Indomethacin 5 MG/ML Ophthalmic Suspension, "Indom ®", NSAID eyedrops administered three days before surgery

Treatment:

Drug: Indom

Yellox

Experimental group

Description:

Bromfenac 0.09 % Ophthalmic Solution, "Yellox®", NSAID eyedrops administered three days before surgery

Treatment:

Drug: Yellox