Conditions: Acute Anterior Uveitis
Keywords: Acute anterior uveitis LME636
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 45
Healthy volunteers: no

Brief 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).

Detailed 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.

Arms:
arm 1: 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) arm 2: Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)

Interventions: intervention 1: LME636 60 mg/mL ophthalmic solution intervention 2: Dexamethasone 0.1% ophthalmic solution intervention 3: LME636 Vehicle
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Inactive ingredients used for masking purposes

Protocol document: