ESBA105 in Patients With Severe Dry Eye

Phase 2

Completed

• Conditions: Eyes Dry Chronic
• Interventions: Biological: ESBA105 ophthalmic solution; Other: ESBA105 vehicle

• Registration Number: NCT01338610
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-04-18
• Study First Submitted QC: 2011-04-18
• Study First Posted: 2011-04-19
• Study Start: 2011-06
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Results First Submitted: 2013-02-28
• Status Verified: 2013-04
• Results First Submitted QC: 2013-04-18
• Last Update Submitted: 2013-04-18
• Results First Posted: 2013-04-19
• Last Update Posted: 2013-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 334

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESBA105	ESBA105 ophthalmic solution	ESBA105 ophthalmic solution, 1 drop in each eye 3 times per day for 4 weeks
Vehicle	ESBA105 vehicle	ESBA105 vehicle, 1 drop in each eye 3 times per day for 4 weeks

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) Global Ocular Discomfort Score, Area Under the Curve, Day 0 to Day 28	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).

Trial Locations

Locations (1)

Contact Alcon Call Center for Trial Locations; 🇺🇸 Fort Worth, Texas, United States