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

April 18, 2011
April 18, 2013
June 2011
February 2012   (final data collection date for primary outcome measure)
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).
Discomfort based on global visual analog scale scores [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01338610 on ClinicalTrials.gov Archive Site
Not Provided
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ESBA105 in Patients With Severe Dry Eye
Evaluation of ESBA105 in the Persistent Relief of Ocular Discomfort in Patients With Severe Dry Eye

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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Eyes Dry Chronic
  • Biological: ESBA105 ophthalmic solution
  • Other: ESBA105 vehicle
    Inactive ingredients used as Run-In and placebo comparator
  • Experimental: ESBA105
    ESBA105 ophthalmic solution, 1 drop in each eye 3 times per day for 4 weeks
    Intervention: Biological: ESBA105 ophthalmic solution
  • Placebo Comparator: Vehicle
    ESBA105 vehicle, 1 drop in each eye 3 times per day for 4 weeks
    Intervention: Other: ESBA105 vehicle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
334
February 2012
February 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01338610
C-10-079
No
Alcon Research
Alcon Research
Not Provided
Not Provided
Alcon Research
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP