ESBA105 in Patients With Severe Dry Eye

NCT01338610 | Completed Phase 2 Results

• 1 other identifier: C-10-079
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 1

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.

Conditions

Eyes Dry Chronic

Keywords

Ocular discomfort

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

ESBA105

EXPERIMENTAL

ESBA105 ophthalmic solution, 1 drop in each eye 3 times per day for 4 weeks

Biological: ESBA105 ophthalmic solution

Vehicle

PLACEBO COMPARATOR

ESBA105 vehicle, 1 drop in each eye 3 times per day for 4 weeks

Other: ESBA105 vehicle

Interventions

ESBA105 ophthalmic solution BIOLOGICAL

ESBA105

ESBA105 vehicle OTHER

Inactive ingredients used as Run-In and placebo comparator

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Interventions

ESBA105

Results Point of Contact

• Title: Christian Leisner
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2011
• First Posted: April 19, 2011
• Study Start: June 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: April 19, 2013
• Results First Posted: April 19, 2013

Record last verified: 2013-04

Locations

US (1)