Proof of Concept Study to Evaluate Safety and Efficacy of LME636 in the Treatment of Acute Anterior Uveitis

• Status: Completed
• Trial end date: 2016-03-21
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine whether topical ocular administration of LME636 60 mg/mL is efficacious in resolving the ocular inflammation in the anterior chamber (AC) associated with acute anterior uveitis (AAU).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Provide written informed consent.

• Diagnosis of non-infectious AAU in at least 1 eye.

• Anterior chamber cell score of 2+ or 3+ as per Standardization of Uveitis Nomenclature (SUN) in at least one eye.

• Able to communicate well with the Investigator, to understand and comply with the requirements of the study.

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Women of child-bearing potential unwilling to use effective contraception methods as defined in the protocol.

• AC cell score of 4+ (SUN) or hypopyon.

• Onset of anterior uveitis more than 2 weeks prior to enrollment in the study.

• Presence of intermediate-, posterior-, or panuveitis in either eye.

• Administration of stable doses >10 mg daily systemic prednisone or corticosteroids as described in the protocol.

• Recurrent corneal abrasion or ulceration in either eye (past or present).

• Tuberculosis (past or present).

• Other protocol-specified exclusion criteria may apply.