RTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain Following Ocular Surgery

Biogen

Status and phase: Completed; Phase 2

Conditions: Inflammation and Pain Following Ocular Surgery

Treatments: Drug: Placebo; Drug: Omaveloxolone Ophthalmic Suspension 1.0%; Drug: Omaveloxolone Opthalmic Suspension 0.5%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02065375

RTA 408-C-1307

Details and patient eligibility

About

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.

Full 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.

Enrollment: 109 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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109 participants in 3 patient groups, including a placebo group

Omaveloxolone Ophthalmic Suspension 1.0%

Experimental group

Description:

Patients will receive a single drop of Omaveloxolone Ophthalmic suspension 1.0% instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery

Treatment:

Drug: Omaveloxolone Ophthalmic Suspension 1.0%

Omaveloxolone Ophthalmic Suspension 0.5%

Experimental group

Description:

Patients will receive a single drop of Omaveloxolone Ophthalmic suspension 0.5% instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery

Treatment:

Drug: Omaveloxolone Opthalmic Suspension 0.5%

Placebo

Placebo Comparator group

Description:

Patients will receive a single drop of vehicle for Omaveloxolone Ophthalmic suspension was instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery

Treatment:

Drug: Placebo