Trials / Completed
CompletedNCT02482129
Proof of Concept Study to Evaluate Safety and Efficacy of LME636 in the Treatment of Acute Anterior Uveitis
A Multicenter, Randomized, Double-Masked, Active-Controlled Study to Evaluate the Safety and Efficacy of LME636 in Patients With Acute Anterior Uveitis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Alcon Research · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LME636 60 mg/mL ophthalmic solution | |
| DRUG | Dexamethasone 0.1% ophthalmic solution | |
| DRUG | LME636 Vehicle | Inactive ingredients used for masking purposes |
Timeline
- Start date
- 2015-07-17
- Primary completion
- 2016-03-21
- Completion
- 2016-03-21
- First posted
- 2015-06-26
- Last updated
- 2018-07-02
- Results posted
- 2017-08-28
Source: ClinicalTrials.gov record NCT02482129. Inclusion in this directory is not an endorsement.