Clinical Evaluation of Systane® Gel Drops in Dry Eye Subjects

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-14

Study Completion Date

2016-06-01

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of Systane® Gel Drops in dry eye subjects following 90 days of QID (4 times/day) dosing.

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Detailed Description

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Conditions

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Dry Eye

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Systane

Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops, 1 drop QID in each eye for 90 days

Group Type EXPERIMENTAL

Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops

Intervention Type OTHER

Interventions

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Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops

Intervention Type OTHER

Other Intervention Names

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Systane® Gel Drops

Eligibility Criteria

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Inclusion Criteria

* Must give informed consent, and be willing and able to attend all study visits.
* Best-corrected visual acuity (BCVA) of ≥ 55 letters in each eye as measured by ETDRS (letters read method).
* Dry eye in both eyes diagnosed by an ophthalmologist.

Exclusion Criteria

* Women of childbearing potential who are pregnant, test positive on a pregnancy test, or breast-feeding.
* Any medical condition (systemic or ophthalmic) that may, in the opinion of the Investigator, preclude the safe administration of test article or safe participation in the study.
* Any contraindications or hypersensitivities to the study medications or their components.
* Ocular surgery (of any type, including PRK, LASIK, Epilasik, etc.) or ocular trauma requiring medical or pharmacological treatment within 1 year of Screening.
* Use of topical ocular prescription or non-prescription medications, RESTASIS or topical ocular steroids within 14 days of Screening.
* Chronic medications (over the counter, prescription, or vitamins) that have not been on a stable dose for at least 30 days prior to Screening.
* Contact lens wear within 1 week of Screening and/or unwillingness to discontinue contact lens wear for the duration of the study.
* Participation in any other clinical trial within 30 days prior to Screening.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No