Clinical trial NCT02482129: Proof of Concept Study to Evaluate Safety and Efficacy of LME636 in the Treatment of Acute Anterior Uveitis
Official title: A Multicenter, Randomized, Double-Masked, Active-Controlled Study to Evaluate the Safety and Efficacy of LME636 in Patients With Acute Anterior Uveitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Anterior Uveitis
Keywords: Acute anterior uveitis
LME636
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2015-06-26
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Number of Responders at Day 15
timeFrame: Baseline (Day 1), Day 15
measure: Mean Best Corrected Visual Acuity (BCVA) at Each Visit
timeFrame: Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29
measure: Mean Intraocular Pressure (IOP) at Each Visit
timeFrame: Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29
measure: Number of Subjects With Increase From Baseline in Slit Lamp Parameters at Any Post-Treatment Visit
timeFrame: Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29
measure: Number of Subjects With an Increase From Baseline in Dilated Fundus Parameters at Any Post-Treatment Visit
timeFrame: Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29
Secondary outcomes:
measure: Number of Subjects With IOP Change From Baseline to Last On-Treatment Assessment
timeFrame: Baseline (Day 1), Up to Day 29
measure: Mean Change From Baseline in BCVA at Each Visit
timeFrame: Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29
measure: Time-to-Response
timeFrame: Baseline (Day 1), Up to Day 15
measure: Use of Rescue Treatment
timeFrame: Day 4, Day 8, Day 15
measure: Mean Serum Concentration of Total LME636 at Each Visit
timeFrame: Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29
measure: Number of Subjects With Anti-LME636 Antibodies Present at Each Visit
timeFrame: Day 1, Day 4, Day 8, Day 15, Day 22, Day 29
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Clinical Scientist NIBR, Alcon
role: STUDY_DIRECTOR
References: