Clinical Trial: Lotemax® Gel 0.5% and Restasis 0.05% in Subjects With Mild or Moderate Keratoconjunctivitis Sicca

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

Official Title: A Randomized, Multi-Center, Parallel-Group, Safety and Efficacy Study of Lotemax® Gel 0.5% and Restasis 0.05% for 12 Weeks in Subjects With Mild or Moderate Keratoconjunctiv

Brief Summary: This study is being conducted to investigate the safety, comfort, and tolerability of 3 treatments: Lotemax® gel 0.5% administered twice daily (BID)with or without Restasis 0.05% administered BID, and Restasis 0.05% treatment alone for 12 weeks and at a follow-up safety visit 1 week post-treatment. This study will also investigate the relative efficacy of Lotemax gel 0.5% administered BID with or without Restasis 0.05% treatment administered BID and of Restasis 0.05% treatment alone for the reduction of clinical signs or symptoms of keratoconjunctivitis sicca (DED) over the first 4 weeks of a 12-week Treatment Period and at the end of a 12-week Treatment Period.

Detailed Summary:
Sponsor: Bausch & Lomb Incorporated

Current Primary Outcome:

• Corneal fluorescein staining [ Time Frame: Mean change from baseline to Visit 4(day 28) ]
• Ocular Surface Disease Index [ Time Frame: Visit 4(day 28) ]
  Ocular Surface Disease Index (OSDI) Questionnaire to measure severity of dry eye. Total score through Visit 4.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Worst Symptom Selection and Scoring [ Time Frame: Visit 2 (Day 0) - Visit 5 (Day 84) ]
  Participants will rate the severity of dry eye symptoms at on a 5-point grading scale for each of 8 symptoms and will then select their most bothersome symptom.
• Ocular Comfort [ Time Frame: Visit 2 (Day 0) - Visit 5 (Day 84) ]
  Subject self-assessment questionnaire of ocular comfort after drug instillation. Graded on a 4 point scale where 0=comfortable and 3=severly uncomfortable
• Tear Osmolarity [ Time Frame: Visit 2 (day 0) - Visit 5 (day 84) ]
  50nL tear sample collected from each eye. Tear osmolarity for each sample will be read with the TearLab instrument in milliosmoles. Average values will be calculated.
• Tear film break-up time (TFBUT) [ Time Frame: Visit 2 (day 0) - Visit 5 ( day 84) ]
  A measure of eye dryness; the cornea and conjunctiva are stained with fluorescein and tear film breakup time is determined.
• Fluorescein Staining [ Time Frame: Visit 2 (day 0) - Visit 5 (day 84) ]
  Corneal total fluorescein stain scoring for punctate keratopathy
• Lissamine green (LG) stain [ Time Frame: Visit 2 (day 0) - Visit 5 (day 84) ]
  LG stain is for monitoring eye dryness in conjunctival tissue.
• Dry eye signs and symptoms [ Time Frame: Visit 2 (day 0) - Visit 5 (day 84) ]
  Subjects and Investigators will grade the overall improvement for change from baseline(Visit 2) in dry eye signs and symptoms for each subject at Visit 5
• Eye Redness [ Time Frame: Visit 2 (day 0) - Visit 5 (day 84) ]
  Degree of eye redness on a 4-point grading scale. Where 0=none and 3=severe
• Anesthetized Schirmer's Test [ Time Frame: Visit 1 (day -14) and Visit 6 (day 84) ]
  The Schirmer's test is a measure of the tonic secretion of the aqueous component of tears. The Schirmer's test will be conducted for both eyes.
• Global Improvement in Dry Eye [ Time Frame: Visit 2 (day 0) and Visit 5 (day 84) ]
  Subjects and Investigators will grade the overall global improvement for change from baseline in dry eye signs and symptoms.

Original Secondary Outcome: Same as current

Information By: Bausch & Lomb Incorporated

Dates:
Date Received: March 21, 2013
Date Started: May 2013
Date Completion:
Last Updated: August 20, 2014
Last Verified: August 2014