Phase 2 N=256 Randomized Quadruple-blind Treatment

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

Inflammation · Pain · Cataract

Bottom Line

View on ClinicalTrials.gov: NCT02329743 ↗

Enrolled (actual)

256

Serious AEs

0.0%

Results posted

Feb 2019

Primary outcome: Primary: Proportion of Subjects With Clearing of Anterior Inflammation — 18; 18; 13 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: RX-10045 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: A.T. Resolve SARL
Primary completion: Sep 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Subjects With Clearing of Anterior Inflammation	18; 18; 13	—
SECONDARY Proportion of Subjects Reporting no Ocular Pain	25; 21; 33	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02329743). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.