ESBA105 in Patients With Severe Dry Eye

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01338610
Recruitment Status : Completed
First Posted : April 19, 2011
Results First Posted : April 19, 2013
Last Update Posted : April 19, 2013
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
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 or disease Intervention/treatment Phase
Eyes Dry Chronic Biological: ESBA105 ophthalmic solution Other: ESBA105 vehicle Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of ESBA105 in the Persistent Relief of Ocular Discomfort in Patients With Severe Dry Eye
Study Start Date : June 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Visual Analog Scale (VAS) Global Ocular Discomfort Score, Area Under the Curve, Day 0 to Day 28 [ Time Frame: Up to 28 days ]
    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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01338610

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

Responsible Party: Alcon Research Identifier: NCT01338610     History of Changes
Other Study ID Numbers: C-10-079
First Posted: April 19, 2011    Key Record Dates
Results First Posted: April 19, 2013
Last Update Posted: April 19, 2013
Last Verified: April 2013

Keywords provided by Alcon Research:
Ocular discomfort

Additional relevant MeSH terms:
Ophthalmic Solutions
Pharmaceutical Solutions