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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter, Randomized, Double-Masked, Active-Controlled Study to Evaluate the Safety and Efficacy of LME636 in Patients With Acute Anterior Uveitis

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 associated (AC) with acute anterior uveitis (AAU).

Detailed Summary: 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.
Sponsor: Alcon Research

Current Primary Outcome:

• Number of Subjects with Reduction from Baseline in AC cell grade of ≥2 at Day 15 [ Time Frame: Baseline (Day 1), Day 15 ]
  Anterior chamber cells will be graded as per Standardization of Uveitis Nomenclature (SUN).
• Mean Best Corrected Visual Acuity (BCVA) at Each Visit [ Time Frame: Up to Day 29 ]
  Visual Acuity (VA) will be measured with the subject's best spectacles or other visual corrective device in place using an ETDRS or Snellen visual acuity chart.
• Mean Intraocular Pressure (IOP) at Each Visit [ Time Frame: Up to Day 29 ]
  IOP (fluid pressure inside the eye) will be assessed using Goldmann applanation tonometry or Tonopen.
• Number of Subjects with a 1 Grade or More Worsening Score from Baseline in Slit Lamp Parameters at Each Visit [ Time Frame: Baseline (Day 1), Up to Day 29 ]
  Ocular signs (lids/lashes, conjunctiva, cornea, anterior chamber, iris, and lens) will be assessed by slit-lamp biomicroscopy.
• Number of Subjects with a 1 Grade or More Worsening Score from Baseline in Dilated Fundus Parameters at Each Visit [ Time Frame: Baseline (Day 1), Up to Day 29 ]
  Fundus parameters (vitreous, retina, macula, and optic nerve) will be analyzed by dilated examination.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Number of Subjects with IOP Elevation at Each Visit [ Time Frame: Baseline (Day 1), Up to Day 29 ]
  IOP will be assessed using Goldmann applanation tonometry or Tonopen. IOP elevation is defined as an increase of ≥10 mmHg from baseline and ≥21 mmHg.
• Mean Change from Baseline in BCVA at Each Visit [ Time Frame: Baseline (Day 1), Up to Day 29 ]
  Visual Acuity (VA) will be measured with the subject's best spectacles or other visual corrective device in place using an ETDRS or Snellen visual acuity chart.
• Time-to-Response [ Time Frame: Baseline (Day 1), Up to Day 29 ]
  Response is defined as reduction from Baseline in AC cell grade of ≥2. Time-to-response will be presented as the number of subjects with first response by visit.
• Use of Rescue Treatment [ Time Frame: Up to Day 29 ]
  Use of rescue treatment will be presented as the number of patients with first use of rescue treatment by visit.
• Mean Serum Concentration of Total LME636 at Each Visit [ Time Frame: Up to Day 29 ]
  Determination of the concentration of total LME636 in serum will be performed using an immunoassay.
• Number of Subjects with Anti-LME636 Antibodies Present at Each Visit [ Time Frame: Up to Day 29 ]
  Serum samples will be collected and assessed for anti-LME636 antibodies.

Original Secondary Outcome: Same as current

Information By: Alcon Research

Dates:
Date Received: June 23, 2015
Date Started: July 2015
Date Completion:
Last Updated: January 13, 2017
Last Verified: April 2016