Efficacy and Safety of RX-10045 Ophthalmic Solution for Ocular Inflammation and Pain in Cataract Surgery

A.T. Resolve SARL

Status and phase: Completed; Phase 2

Conditions: Inflammation; Cataract; Pain

Treatments: Drug: RX-10045

Study type: Interventional

Funder types: Industry

Identifiers

NCT02329743

ATR-45-1401

Details and patient eligibility

About

The primary objective of this study is to assess the efficacy and safety of 2 concentrations of RX-10045 ophthalmic solution, 0.05% and 0.1%, compared to placebo for the treatment of ocular inflammation and pain in subjects undergoing cataract surgery.

Enrollment: 256 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation in the capsular bag.

Exclusion criteria

• Any additional surgical procedures at the time of the cataract surgery
• Refractive surgery in the study eye within the past 2 years
• History or presence of noninfectious inflammatory ocular disease (e.g., episcleritis, scleritis, uveitis) in either eye
• Intraocular pressure of > 21 mm Hg in either eye
• Proliferative or severe nonproliferative diabetic retinopathy in either eye
• Neovascular/wet age-related macular degeneration in either eye

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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256 participants in 3 patient groups, including a placebo group

RX-10045 0.05% nanomicellar solution

Experimental group

Description:

topical eye drops

Treatment:

Drug: RX-10045

RX-10045 0.1% nanomicellar solution

Experimental group

Description:

topical eye drops

Treatment:

Drug: RX-10045

Vehicle

Placebo Comparator group

Description:

topical eye drops

Treatment:

Drug: RX-10045