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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-17

Study Completion Date

2016-03-21

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Acute Anterior Uveitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LME636

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)

Group Type EXPERIMENTAL

LME636 60 mg/mL ophthalmic solution

Intervention Type DRUG

LME636 Vehicle

Intervention Type DRUG

Inactive ingredients used for masking purposes

Dexamethasone

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

Group Type ACTIVE_COMPARATOR

Dexamethasone 0.1% ophthalmic solution

Intervention Type DRUG

Interventions

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LME636 60 mg/mL ophthalmic solution

Intervention Type DRUG

Dexamethasone 0.1% ophthalmic solution

Intervention Type DRUG

LME636 Vehicle

Inactive ingredients used for masking purposes

Intervention Type DRUG

Eligibility Criteria

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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.

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No