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OpenTrials
Completed

NCT Number: NCT01338610

ESBA105 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.

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Key information

Conditions

Eyes Dry Chronic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ESBA105 ophthalmic solution

Biological

ESBA105 vehicle

Other

Inactive ingredients used as Run-In and placebo comparator

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 19, 2011
Registry last updated
Apr 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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