ESBA105 in Patients With Severe Dry Eye

Eyes Dry Chronic Clinical Trial

Official title:

Evaluation of ESBA105 in the Persistent Relief of Ocular Discomfort in Patients With Severe Dry Eye

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01338610
• Other study ID #: C-10-079
• Status: Completed
• Phase: Phase 2
• First received: April 18, 2011
• Last updated: April 18, 2013
• Start date: June 2011
• Est. completion date: February 2012

Study information

• Verified date: April 2013
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eyes Dry Chronic

Intervention

Biological:
• ESBA105 ophthalmic solution

Other:
• ESBA105 vehicle
Inactive ingredients used as Run-In and placebo comparator

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Up to 28 days	No