Title

Efficacy and Safety of RX-10045 Ophthalmic Solution for Ocular Inflammation and Pain in Cataract Surgery
A Multicenter, Double-Masked, Parallel-Group, Vehicle-Controlled Study to Assess the Efficacy and Safety of RX-10045 Nanomicellar Ophthalmic Solution for Treatment of Ocular Inflammation and Pain in Subjects Undergoing Cataract Surgery
  • Phase

    Phase 2
  • Study Type

    Interventional
  • Intervention/Treatment

    rx-10045 ...
  • Study Participants

    256
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.
Study Started
Dec 31
2014
Primary Completion
Sep 30
2015
Study Completion
Sep 30
2015
Results Posted
Feb 05
2019
Last Update
Feb 20
2019

Drug RX-10045

topical therapy

RX-10045 0.05% nanomicellar solution Experimental

topical eye drops

RX-10045 0.1% nanomicellar solution Experimental

topical eye drops

Vehicle Placebo Comparator

topical eye drops

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

Summary

RX-10045 0.05% Nanomicellar Solution

RX-10045 0.1% Nanomicellar Solution

Vehicle

All Events

Event Type Organ System Event Term

Proportion of Subjects With Clearing of Anterior Inflammation

score of zero for the Standardization of Uveitis Nomenclature scale

RX-10045 0.05% Nanomicellar Solution

RX-10045 0.1% Nanomicellar Solution

Vehicle

Proportion of Subjects Reporting no Ocular Pain

RX-10045 0.05% Nanomicellar Solution

RX-10045 0.1% Nanomicellar Solution

Vehicle

Total

236
Participants

Age, Continuous

66.5
years (Mean)
Standard Deviation: 9.2

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Sex: Female, Male

Overall Study

RX-10045 0.05% Nanomicellar Solution

RX-10045 0.1% Nanomicellar Solution

Vehicle

Drop/Withdrawal Reasons

RX-10045 0.05% Nanomicellar Solution

RX-10045 0.1% Nanomicellar Solution

Vehicle