ESBA105 in Patients With Severe Dry Eye

Alcon Research334 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

334

Conditions

Eyes Dry Chronic

Interventions

ESBA105 ophthalmic solutionBIOLOGICAL

ESBA105 vehicleOTHER

Inactive ingredients used as Run-In and placebo comparator

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Outcomes

Primary Outcomes

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).

Time frame: Up to 28 days

Data from ClinicalTrials.gov

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