PGE2 Levels in Patient Treated With NSAIDs

U

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

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems