ESBA105 in Patients With Severe Dry Eye

NCT ID: NCT01338610

Last Updated: 2013-04-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

334 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-02-29

Brief Summary

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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

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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.

Conditions

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Eyes Dry Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ESBA105

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

Group Type EXPERIMENTAL

ESBA105 ophthalmic solution

Intervention Type BIOLOGICAL

Vehicle

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

Group Type PLACEBO_COMPARATOR

ESBA105 vehicle

Intervention Type OTHER

Inactive ingredients used as Run-In and placebo comparator

Interventions

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ESBA105 ophthalmic solution

Intervention Type BIOLOGICAL

ESBA105 vehicle

Inactive ingredients used as Run-In and placebo comparator

Intervention Type OTHER

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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C-10-079

Identifier Type: -

Identifier Source: org_study_id

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