Overview

This trial is active, not recruiting.

Condition inflammation and pain following ocular surgery
Treatments rta 408 0.5% ophthalmic suspension, rta 408 1.0% ophthalmic suspension
Phase phase 2
Sponsor Reata Pharmaceuticals, Inc.
Collaborator AbbVie
Start date February 2014
End date September 2014
Trial size 109 participants
Trial identifier NCT02065375, RTA 408-C-1307

Summary

This study assesses the efficacy and safety of two concentrations of RTA 408 Ophthalmic Suspension in the treatment of patients who have inflammation and pain following ocular 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 treatment
Arm
(Placebo Comparator)
Patients will be randomized to twice-daily dosing of ophthalmic suspension (RTA 408 0.5% or Placebo) in the study eye for 14 days
rta 408 0.5% ophthalmic suspension
(Placebo Comparator)
Patients will be randomized to twice-daily dosing of ophthalmic suspension (RTA 408 1.0% or Placebo) in the study eye for 14 days
rta 408 1.0% ophthalmic suspension

Primary Outcomes

Measure
Anterior Chamber Cell Count
time frame: 14 days

Secondary Outcomes

Measure
Pain
time frame: 14 days

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Be greater than or equal to 18 years of age of either sex or any race; 2. Have undergone unilateral cataract extraction via phacoemulsification on the day prior to study enrollment/randomization; 3. Have a grade of ≥2 in anterior chamber cell score on day after surgery (Day 1); 4. Have a potential post-operative pin-hole visual acuity (VA) of greater than 1.0 logarithm of the minimum angle of resolution (logMAR) in the operative eye and fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart; Exclusion Criteria: 1. Have any intraocular inflammation present in the study eye during the screening slit lamp examination; 2. Have a score greater than "0" on the Ocular Pain Assessment at Screening in the study eye; 3. Have an immunosuppressive disease or an autoimmune disease that in the opinion of the Investigator could affect the quality of the ocular surface; 4. Have active or chronic/recurrent ocular or systemic disease that is uncontrolled and will likely affect wound healing; 5. Have an IOP ≤ 5 mmHg in either eye; 6. Require the use of a contact lens or a collagen shield within 72 hours of investigational drug treatment or during the study period in the study eye; be unwilling to discontinue use of contact lenses during study period in the study eye; 7. Require use of non-diagnostic topical ophthalmic solutions (other than perioperative mydriatics, anesthetics and antiseptics, prophylactic antibiotics, lid scrubs for mild blepharitis, or artificial tears for the management of dry eye) in the study eye for the duration of the study;

Additional Information

Official title A Multicenter, Randomized, Dose-Ranging, Double-Masked, Placebo-Controlled Phase 2 Study Evaluating the Safety and Efficacy of RTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain Following Ocular Surgery
Description Following ophthalmic surgery, the current standard of care includes a topical ophthalmic corticosteroid or other anti-inflammatory agent to treat ocular inflammation and improve patient comfort. If left untreated, inflammation of the eye may result in further ocular complications including scarring, vision loss, or blindness. Although the exact dosing regimen is physician-dependent, patients are typically prescribed a topical corticosteroid for a period of 2-4 weeks following surgery, being tapered over the course of delivery as the inflammation subsides. Topical anti-inflammatory agents are usually administered multiple times per day, particularly in the early period following ophthalmic surgery. Continuing efforts in drug development aim to identify alternatives to ophthalmic corticosteroid use, due to their well-known local and systemic negative side effects.
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Reata Pharmaceuticals, Inc..