Overview

This trial is active, not recruiting.

Conditions corneal endothelial cell loss, ocular pain, ocular inflammation, cataract surgery
Treatments placebo, 0.5% rta 408 ophthalmic suspension, 1% rta 408 ophthalmic suspension
Phase phase 2
Sponsor Reata Pharmaceuticals, Inc.
Collaborator AbbVie
Start date May 2014
End date February 2015
Trial size 300 participants
Trial identifier NCT02128113, RTA 408-C-1309

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Placebo Comparator)
Placebo ophthalmic suspension, one drop, applied twice daily for a maximum of 28 days
placebo
Opthalmic suspension manufactured to mimic RTA 408 suspension
(Experimental)
0.5% RTA 408 ophthalmic suspension, one drop applied twice daily for a maximum of 28 days
0.5% rta 408 ophthalmic suspension
0.5% ophthalmic suspension of RTA 408
(Experimental)
1% RTA 408 ophthalmic suspension, one drop applied twice daily for a maximum of 28 days
1% rta 408 ophthalmic suspension
1% ophthalmic suspension of RTA 408

Primary Outcomes

Measure
Count of corneal endothelial cells
time frame: 12 weeks

Secondary Outcomes

Measure
Measure of inflammation
time frame: 2 weeks
Measure of pain
time frame: 1 day

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: 1. Be male or female and ≥18 years of age and ≤80 years of age 2. Plan to undergo cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens 3. Have the potential, in the opinion of the investigator, to improve best-corrected visual acuity in the study eye after surgery 4. Have Grade 3, 4, or 5 nuclear cataract in the study eye, according to the LOCS III 5. Have corneal endothelium in the study eye that can be accurately assessed using specular microscopy 6. Have endothelial cell density of >1800 cells/mm2 in the study eye at the Screening Visit 7. Have a pinhole visual acuity (VA) of at least 1.0 logarithm of the minimum angle of resolution (logMAR) in the study eye and fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart Exclusion Criteria: 1. Have a score >0 on the ocular pain assessment at the Screening Visit or the Randomization Visit in the study eye 2. Have an active immunosuppressive disease or an autoimmune disease that, in the opinion of the investigator, could affect the quality of the ocular surface 3. Have active or chronic/recurrent ocular or systemic disease that is uncontrolled and will likely affect wound healing 4. Have an intraocular pressure (IOP) ≤5 mmHg in either eye 5. Have had corneal or retinal surgery (laser or incisional) within the past 6 months, or be planning to have laser or incisional surgery during the study period in the study eye 6. Have the presence of guttae Stage 2 or greater or other abnormality in the study eye that does not allow for accurate corneal endothelial cell assessments

Additional Information

Official title A Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group, Phase 2 Study of the Efficacy and Safety of RTA 408 For the Prevention of Corneal Endothelial Cell Loss in Patients Undergoing Cataract Surgery
Description Many ocular diseases are characterized by oxidative stress and/or inflammation. Oxidative stress is also known to adversely impact corneal endothelial cells, and may be a factor resulting in the acute decrease in corneal endothelial cell density following ocular surgery. While corticosteroids provide potent anti-inflammatory efficacy in a wide range of acute and chronic inflammatory ocular diseases, their use is limited by their side effect profile, which includes the potential to elevate IOP and induce cataract formation. In addition, most available ophthalmic anti-inflammatory treatments, including corticosteroids, do not directly protect against the underlying oxidative stress component of the disease process. Consequently, there is a clinical need for agents that protect against oxidative stress and provide anti-inflammatory efficacy without inducing steroid-like side effects. This study will assess the safety and efficacy of RTA 408 Ophthalmic Suspension (0.5% or 1%) versus vehicle for the prevention of corneal endothelial cell loss in patients undergoing cataract surgery.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Reata Pharmaceuticals, Inc..