ESBA105 in Patients With Severe Dry Eye

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01338610
First received: April 18, 2011
Last updated: April 18, 2013
Last verified: April 2013
  Purpose

The purpose of this study was to evaluate the efficacy of ESBA105 over vehicle in reducing the ocular symptoms of dry eye disease, as measured by a mean global Visual Analog Scale (VAS) discomfort score.


Condition Intervention Phase
Eyes Dry Chronic
Biological: ESBA105 ophthalmic solution
Other: ESBA105 vehicle
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of ESBA105 in the Persistent Relief of Ocular Discomfort in Patients With Severe Dry Eye

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Visual Analog Scale (VAS) Global Ocular Discomfort Score, Area Under the Curve, Day 0 to Day 28 [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]
    An electronic Visual Analog Scale (eVAS) was used by the subject to assess ocular discomfort, both frequency and severity, at Day 0 (pre-treatment) and daily thereafter for 28 days. Assessments were entered into a LogPad® (handheld electronic device). The VAS frequency score ranged from 0 (rarely) to 100 (all the time), and the VAS severity score ranged from 0 (very mildly uncomfortable) to 100 (very severely uncomfortable). The Global Ocular Discomfort Score is a composite of the frequency and severity VAS scores (0-100).


Enrollment: 334
Study Start Date: June 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ESBA105
ESBA105 ophthalmic solution, 1 drop in each eye 3 times per day for 4 weeks
Biological: ESBA105 ophthalmic solution
Placebo Comparator: Vehicle
ESBA105 vehicle, 1 drop in each eye 3 times per day for 4 weeks
Other: ESBA105 vehicle
Inactive ingredients used as Run-In and placebo comparator

Detailed Description:

Following Run-In, patients qualifying for treatment were randomized 2:1 to receive ESBA105 (experimental group) or Vehicle (control group) for 4 weeks. Patients not qualifying for treatment (based on global VAS discomfort score), were discontinued from the study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ongoing physician diagnosis of dry eye for at least 6 months.
  • Use of artificial tears, gels, lubricants, or re-wetting drops on a regular basis.
  • Experience persistent ocular discomfort.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Contact lens wearers.
  • Severe Sjogren's Syndrome.
  • History of corneal surgery including refractive surgeries.
  • Intraocular surgery within 6 months of Visit 1.
  • Intraocular or periocular injection within 6 months of Visit 1.
  • Lid function abnormalities.
  • Use of steroids, tetracycline, doxycycline, etc., within 30 days of Visit 1.
  • Any acute infectious or non-infectious ocular condition of the anterior or posterior segments in either eye within 30 days of Visit 1.
  • Diseases/conditions of ocular surface associated with clinically significant scarring/destruction of conjunctiva/cornea.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01338610

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01338610     History of Changes
Other Study ID Numbers: C-10-079
Study First Received: April 18, 2011
Results First Received: February 28, 2013
Last Updated: April 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
Ocular discomfort

ClinicalTrials.gov processed this record on April 17, 2014