Phase 2
Completed N=256
Efficacy and Safety of RX-10045 Ophthalmic Solution for Ocular Inflammation and Pain in Cataract Surgery
Source: ClinicalTrials.gov NCT02329743 ↗Enrolled (actual)
256
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcomePrimary: Proportion of Subjects With Clearing of Anterior Inflammation — 18; 18; 13 Participants
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.
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 | — |
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
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. Informational only — not medical advice.