Clinical Evaluation of Systane® Balance in Dry Eye Subjects

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-26

Study Completion Date

2016-06-20

Brief Summary

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

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Detailed Description

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This study was conducted in India.

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 Balance

Propylene Glycol 0.6% eye drops, 1 drop QID (with the last dose of each day at bedtime) in each eye for 90 days

Group Type EXPERIMENTAL

Propylene Glycol 0.6% eye drops

Intervention Type OTHER

Interventions

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Propylene Glycol 0.6% eye drops

Intervention Type OTHER

Other Intervention Names

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Systane® Balance

Eligibility Criteria

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Inclusion Criteria

* Sign informed consent and willing and able to attend all study visits;
* Dry eye in both eyes diagnosed by an ophthalmologist;

Exclusion Criteria

* Women of childbearing potential who are pregnant or breastfeeding;
* Any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in the study;
* Ocular surgery 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;
* Use of any artificial tears/gels/lubricants/rewetting drops within 4 hours of Screening;
* Contact lens wear within 1 week of Screening and/or unwillingness to discontinue contact lens wear for the duration of the study;

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No