Proof of Concept Study to Evaluate Safety and Efficacy of LME636 in the Treatment of Acute Anterior Uveitis
| Status: | Completed |
|---|---|
| Conditions: | Ocular, Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2015 |
| End Date: | March 2016 |
A Multicenter, Randomized, Double-Masked, Active-Controlled Study to Evaluate the Safety and Efficacy of LME636 in Patients With Acute Anterior Uveitis
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 associated
(AC) with acute anterior uveitis (AAU).
mg/mL is efficacious in resolving the ocular inflammation in the anterior chamber associated
(AC) with acute anterior uveitis (AAU).
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.
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.
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 locally
administered corticosteroids as described in the protocol.
- Corneal abrasion or ulceration in either eye (past or present).
- Tuberculosis (past or present).
- Other protocol-specified exclusion criteria may apply.
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