- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01338610
ESBA105 in Patients With Severe Dry Eye
April 18, 2013 updated by: Alcon Research
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
334
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
-
Fort Worth, Texas, United States, 76134
- Contact Alcon Call Center for Trial Locations
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ESBA105
ESBA105 ophthalmic solution, 1 drop in each eye 3 times per day for 4 weeks
|
|
Placebo Comparator: Vehicle
ESBA105 vehicle, 1 drop in each eye 3 times per day for 4 weeks
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Inactive ingredients used as Run-In and placebo comparator
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Up to 28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
April 18, 2011
First Submitted That Met QC Criteria
April 18, 2011
First Posted (Estimate)
April 19, 2011
Study Record Updates
Last Update Posted (Estimate)
April 19, 2013
Last Update Submitted That Met QC Criteria
April 18, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C-10-079
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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