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

NCT02065375 | Completed Phase 2 Results

• 1 other identifier: RTA 408-C-1307
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 6

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.

Conditions

Inflammation and Pain Following Ocular Surgery

Keywords

RTA 408; Ocular surgery; Cataract surgery; Ocular inflammation; Ocular pain; Eye inflammation; omaveloxolone

Outcome Measures

Primary Outcomes (2)

• Absence of Anterior Chamber Cells at Day 15 (Visit 5)

  Count of participants who had absence of anterior chamber cells at Day 15. White blood cells were counted. In a healthy eye, the anterior chamber should not have any blood cells present. "Yes" indicates an absence of anterior chamber cells. Data for visits after a patient was discontinued for lack of efficacy were imputed as failures and missing data were imputed using last observation carried forward.

  15 days after the participant receives the first dose

• Absence of Ocular Pain at Day 4 (Visit 3)

  Participants were asked to report their pain on Day 4 using the Numerical Pain Rating Scale (NPRS) for patients receiving active drug compared to patients receiving placebo. The NPRS is an 11-point numeric scale, which ranges from "0" representing "no pain" to "10" representing the "worst pain imaginable". Lower scores indicate less pain. Participants reporting '0' were recorded as "Yes" while patients reporting any other pain score were recorded as "No". Data for visits after a patient was discontinued for lack of efficacy were imputed as failures and missing data were imputed using last observation carried forward.

  4 days after the participant receives the first dose

Study Arms (3)

Omaveloxolone Ophthalmic Suspension 1.0%

EXPERIMENTAL

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

Drug: Omaveloxolone Ophthalmic Suspension 1.0%

Omaveloxolone Ophthalmic Suspension 0.5%

EXPERIMENTAL

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

Drug: Omaveloxolone Opthalmic Suspension 0.5%

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Omaveloxolone Ophthalmic Suspension 1.0% DRUG

Also known as: RTA 408

Omaveloxolone Ophthalmic Suspension 1.0%

Omaveloxolone Opthalmic Suspension 0.5% DRUG

Also known as: RTA 408

Omaveloxolone Ophthalmic Suspension 0.5%

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be greater than or equal to 18 years of age of either sex or any race;
• Have undergone unilateral cataract extraction via phacoemulsification on the day prior to study enrollment/randomization;
• Have a grade of ≥2 in anterior chamber cell score on day after surgery (Day 1);
• 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;

You may not qualify if:

• Have any intraocular inflammation present in the study eye during the screening slit lamp examination;
• Have a score greater than "0" on the Ocular Pain Assessment at Screening in the study eye;
• Have an immunosuppressive disease or an autoimmune disease that in the opinion of the Investigator could affect the quality of the ocular surface;
• Have active or chronic/recurrent ocular or systemic disease that is uncontrolled and will likely affect wound healing;
• Have an intraocular pressure (IOP) ≤ 5 mmHg in either eye;
• 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;
• 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;

Sponsors & Collaborators

• Biogen: lead
• AbbVie: collaborator

Study Sites (6)

Unknown Facility

Garden Grove, California, 92843, United States

Location

Unknown Facility

Fort Myers, Florida, 33907, United States

Location

Unknown Facility

Kansas City, Missouri, 64133, United States

Location

Unknown Facility

Elizabeth City, North Carolina, 27909, United States

Location

Unknown Facility

Austin, Texas, 78731, United States

Location

Unknown Facility

Houston, Texas, 75022, United States

Location

MeSH Terms

Conditions

Inflammation; Eye Pain; Endophthalmitis

Interventions

omaveloxolone

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Eye Manifestations; Eye Diseases; Signs and Symptoms; Pain; Neurologic Manifestations; Eye Infections; Infections

Results Point of Contact

• Title: US Biogen Clinical Trial Center
• Organization: Biogen

clinicaltrials@biogen.com

866-633-4636

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2014
• First Posted: February 19, 2014
• Study Start: February 28, 2014
• Primary Completion: September 30, 2014
• Study Completion: September 30, 2014
• Last Updated: June 3, 2025
• Results First Posted: April 19, 2023

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (6)