Back to resultsESBA105 in Patients With Severe Dry Eye
Primary Purpose
Eyes Dry Chronic
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ESBA105 ophthalmic solution
ESBA105 vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Eyes Dry Chronic focused on measuring Ocular discomfort
Eligibility 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.
Sites / Locations
- Contact Alcon Call Center for Trial Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ESBA105
Vehicle
Arm Description
ESBA105 ophthalmic solution, 1 drop in each eye 3 times per day for 4 weeks
ESBA105 vehicle, 1 drop in each eye 3 times per day for 4 weeks
Outcomes
Primary Outcome Measures
Visual Analog Scale (VAS) Global Ocular Discomfort Score, Area Under the Curve, Day 0 to Day 28
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01338610
Brief Title
ESBA105 in Patients With Severe Dry Eye
Official Title
Evaluation of ESBA105 in the Persistent Relief of Ocular Discomfort in Patients With Severe Dry Eye
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eyes Dry Chronic
Keywords
Ocular discomfort
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
334 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ESBA105
Arm Type
Experimental
Arm Description
ESBA105 ophthalmic solution, 1 drop in each eye 3 times per day for 4 weeks
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
ESBA105 vehicle, 1 drop in each eye 3 times per day for 4 weeks
Intervention Type
Biological
Intervention Name(s)
ESBA105 ophthalmic solution
Intervention Type
Other
Intervention Name(s)
ESBA105 vehicle
Intervention Description
Inactive ingredients used as Run-In and placebo comparator
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS) Global Ocular Discomfort Score, Area Under the Curve, Day 0 to Day 28
Description
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).
Time Frame
Up to 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Contact Alcon Call Center for Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
Learn more about this trial
ESBA105 in Patients With Severe Dry Eye
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