Clinical trial NCT02065375: RTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain Following Ocular Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Inflammation and Pain Following Ocular Surgery
Keywords: RTA 408
Ocular surgery
Cataract surgery
Ocular inflammation
Ocular pain
Eye inflammation
omaveloxolone
Lead sponsor: Biogen
Sponsor class: INDUSTRY
Collaborators: name: AbbVie
First posted: 2014-02-19
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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 intraocular pressure (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;

Primary outcomes:
measure: Absence of Anterior Chamber Cells at Day 15 (Visit 5)
timeFrame: 15 days after the participant receives the first dose
measure: Absence of Ocular Pain at Day 4 (Visit 3)
timeFrame: 4 days after the participant receives the first dose
Secondary outcomes:
Other outcomes:
Locations:
city: Garden Grove
country: United States
state: California
city: Fort Myers
country: United States
state: Florida
city: Kansas City
country: United States
state: Missouri
city: Elizabeth City
country: United States
state: North Carolina
city: Austin
country: United States
state: Texas
city: Houston
country: United States
state: Texas
Study officials:
References: