CompletedPhase 2

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

United States109 participantsStarted 2014-02-28

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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;

Exclusion criteria

✕. 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;

What they're measuring

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

Timeframe: 15 days after the participant receives the first dose

Absence of Ocular Pain at Day 4 (Visit 3)

Timeframe: 4 days after the participant receives the first dose

Trial details

NCT IDNCT02065375

SponsorBiogen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-09-30

Results submitted2023-03-28

View on ClinicalTrials.gov More Inflammation and Pain Following Ocular Surgery trials