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RTA 408 Ophthalmic Suspension for the Prevention of Corneal Endothelial Cell Loss Following Cataract Surgery - GUARD

NCT02128113 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 307

Last updated 2025-06-03

Study results available
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Summary

This study assesses the efficacy and safety of two concentrations of omaveloxolone (RTA 408) ophthalmic suspension for the prevention of corneal endothelial cell loss following cataract surgery.

Conditions

  • Corneal Endothelial Cell Loss
  • Ocular Pain
  • Ocular Inflammation
  • Cataract Surgery

Interventions

DRUG

Vehicle Ophthalmic Solution

Opthalmic suspension manufactured to mimic RTA 408 suspension

DRUG

Omaveloxolone Ophthalmic Suspension 0.5%

0.5% ophthalmic suspension of RTA 408

DRUG

Omaveloxolone Ophthalmic Suspension 1%

1% ophthalmic suspension of RTA 408

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-02-28
Completion
2015-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02128113 on ClinicalTrials.gov