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

Alcon

Status and phase: Completed; Phase 2

Conditions: Acute Anterior Uveitis

Treatments: Drug: LME636 60 mg/mL ophthalmic solution; Drug: LME636 Vehicle; Drug: Dexamethasone 0.1% ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT02482129

LME636-2201

Details and patient eligibility

About

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).

Full description

Eligible subjects will be randomized to LME636 or Dexamethasone in a 3:1 ratio at the time they present to the trial site with the AAU flare and will enter treatment for 28 full days. Subjects with worsening disease from Visit 2/Day 4 onward or subjects without improvement after 14 days of treatment will be discontinued from treatment, unmasked and treated with a rescue regimen at the discretion of the investigator.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 2 patient groups

LME636

Experimental group

Description:

LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4)

Treatment:

Drug: LME636 60 mg/mL ophthalmic solution

Drug: LME636 Vehicle

Dexamethasone

Active Comparator group

Description:

Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)

Treatment:

Drug: Dexamethasone 0.1% ophthalmic solution