Prospective Study With Adjunctive Once Daily Topical Nepafenac 0.3% Versus Placebo

Intuor Technologies

Status: Completed

Conditions: Cystoid Macular Edema

Treatments: Drug: Nepafenac 0.3%; Drug: Saline Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT03025945

CME and nepafenac 0.3%

Details and patient eligibility

About

Prospective, randomized, double-masked, placebo-controlled clinical study to define the effective use of a topical non-steroidal anti-inflammatory drug added to topical steroid use after uncomplicated phacoemulsification for the prevention of pseudophakic cystoid macular edema.

Enrollment: 662 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects, 18 and older subjects with visually significant cataracts and were to undergo phacoemulsification with implantation of an intracapsular positioned intraocular lens.

Exclusion criteria

• previous uveitis (<1 year) previous anterior segment intraocular surgery hypersensitivity or allergy to NSAIDs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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662 participants in 2 patient groups, including a placebo group

nepafenac 0.3%

Experimental group

Description:

nepafenac 0.3% ophthalmic solution dosed once daily

Treatment:

Drug: Nepafenac 0.3%

Saline Solution

Placebo Comparator group

Description:

sterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily

Treatment:

Drug: Saline Solution