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Safety and Efficacy Study of rEV131 in the Treatment of Ocular Inflammation After Cataract Surgery

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00353964
Enrollment
Unknown
Registered
2006-07-19
Start date
Unknown
Completion date
Unknown
Last updated
2006-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Inflammation

Brief summary

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.

Interventions

DRUGrEV131
DRUGPrenisolone sodium phosphate 1.0%
DRUGrEV131 vehicle

Sponsors

Evolutec Group
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Countries

United States

Contacts

Primary ContactSusan French, ORA Clinical Research & Development Inc.
sfrench@oraclinical.com978-685-8900

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026