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
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, see Learn About Clinical Studies.

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

Additional relevant MeSH terms:
Ophthalmic Solutions
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014