PGE2 Levels in Patient Treated With NSAIDs

Ocular Inflammation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03597867
• Other study ID #: 02/2017
• Status: Completed
• Phase: Phase 3
• Start date: April 25, 2018
• Est. completion date: July 9, 2018

Study information

• Verified date: July 2018
• Source: University of Trieste
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: July 9, 2018
• Est. primary completion date: July 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Ocular Inflammation

Intervention

Other:
• Placebo
Artificial tears for 3 days preoperatively

Drug:
• Dicloftil
Dosing of drug 3 days prior to surgery
• Nevanac
Dosing of drug 3 days prior to surgery
• Indom
Dosing of drug 3 days prior to surgery
• Yellox
Dosing of drug 3 days prior to surgery

Locations

Country	Name	City	State
Italy	Eye Clinic, Departement of Medical Surgical Sciences and Health, University of Trieste	Trieste	TS

Sponsors (1)

Lead Sponsor	Collaborator
University of Trieste

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitreous NSAIDs and PGE2 levels		3 days after topical NSAID administration