Efficacy and Safety of RX-10045 Ophthalmic Solution for Ocular Inflammation and Pain in Cataract Surgery
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain, Ocular |
| Therapuetic Areas: | Musculoskeletal, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/22/2019 |
| Start Date: | December 2014 |
| End Date: | September 2015 |
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
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.
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.
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
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