Safety and Efficacy Study of rEV131 in the Treatment of Ocular Inflammation After Cataract Surgery
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Contact: | Susan French, ORA Clinical Research & Development Inc. |
| Email: | sfrench@oraclinical.com |
| Phone: | 978-685-8900 |
A Multi-Center, Randomized, Double Masked, Placebo and Active Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of rEV131 2.5 Mg/mL, rEV131 1.25 Mg/mL, rEV131 0.625 Mg/mL, for the Treatment of Ocular Inflammation After Cataract Surgery
The purpose of this study is to evaluate the safety and effectiveness of three
concentrations of rEV131, a new investigational anti-inflammatory agent, compared to placebo
(an inactive substance) and an FDA approved anti-inflammatory agent in patients with ocular
inflammation who have undergone cataract extraction with intra-ocular lens implantation.
concentrations of rEV131, a new investigational anti-inflammatory agent, compared to placebo
(an inactive substance) and an FDA approved anti-inflammatory agent in patients with ocular
inflammation who have undergone cataract extraction with intra-ocular lens implantation.
Inclusion Criteria:
- be male or female who has undergone unilateral cataract extraction by
phacoemulsification (PHACO) method with implantation of a posterior chamber
intraocular lens
Exclusion Criteria:
- have unstable glaucoma
- have an active bacterial and/or viral infection
- use any ocular or systemic anti-inflammatory agents within 1 week prior to enrollment
and for the duration of the study.
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