To compare the efficacy of bromfenac ophthalmic solution 0.09% to dexamethasone ophthalmic solution 0.1% for reducing postoperative inflammation after cataract surgery.

Phase 1

• Conditions: Postoperative ocular inflammation after cataract surgery; MedDRA version: 20.0Level: PTClassification code 10015943Term: Eye inflammationSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2016-004358-14-IT
• Lead Sponsor: AZIENDA OSPEDALIERA ARCISPEDALE SANTA MARIA NUOVA/IRCCS DI REGGIO EMILIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

-Patients that underwent uneventful cataract surgery;
-Patients aged >60 year old (for women, the menopausal state is assumed);
-A signed informed consent for this study protocol is mandatory.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

Patients with history of ocular inflammation or trauma, previous intraocular surgery, corneal haze, pseudoexfoliatio lentis, retinal vascular disease, diabetic retinopathy, variation of the foveal profile at OCT (including macular edema and epiretinal membrane), moderate to severe age related macular degeneration.
Patients could not be enrolled in another clinical study concurrently.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified