In Vivo Measurement of Corneal Epithelial Changes in Dry Eye Patients

Alcon

Status: Completed

Conditions: Dry Eye Syndrome

Treatments: Other: SYSTANE® Gel Drop lubricant eye gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01483989

SMA-09-49

Details and patient eligibility

About

The purpose of this study is to measure corneal epithelial changes in dry eye subjects using a novel lubricant eye gel.

Full description

The purpose of this study is to measure corneal epithelial changes in dry eye (DE) subjects using a novel lubricant eye gel.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Subjects must have history of dry eye as determined by:

1. Questionnaire
2. Tear Film Break Up Time less than or equal to 10 seconds
3. Schirmer's score of less than or equal to 5 mm
4. Corneal staining greater than or equal to 3 in either eye, and
5. Positive for conjunctival staining (greater than or equal to 1)

Exclusion criteria

• Patients cannot wear contact lenses within 1 week prior nor during the study, and cannot have a history of hypersensitivity to any component of Systane Gel Drops.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

SYSTANE® Gel Drops Lubricant eye gel

Experimental group

Description:

SYSTANE Gel Drops Lubricant Eye gel dosed (bilaterally) 3 times per day for the 28 day period.

Treatment:

Other: SYSTANE® Gel Drop lubricant eye gel