Clinical Trial: Evaluation of the Efficacy and Safety of PRX-100 in the Treatment of Early to Moderate Presbyopia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Single-Center, Double-Masked Evaluation of the Efficacy and Safety of PRX-100 (Aceclidine/Tropicamide) Ophthalmic Topical Formulation in the Treatment of Early to Moderate Pres
Brief Summary: This is a one-day, randomized, double-masked, single-center evaluation of the efficacy and safety of PRX-100 ophthalmic solution compared to placebo in 20 subjects (randomized 4:1, PRX-100:placebo) to evaluate the safety of PRX-100 and the magnitude and duration of effects on improving near-vision acuity.
Detailed Summary:
Sponsor: Presbyopia Therapies, LLC
Current Primary Outcome: binocular assessment of uncorrected near visual acuity [ Time Frame: day 1 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: pupil diameter [ Time Frame: day 1 ]
Original Secondary Outcome: Same as current
Information By: Presbyopia Therapies, LLC
Dates:
Date Received: September 16, 2015
Date Started: September 2015
Date Completion:
Last Updated: February 18, 2016
Last Verified: February 2016