Clinical Evaluation of Systane® Balance in Dry Eye Subjects

Alcon

Status

Terminated

Conditions

Dry Eye

Treatments

Other: Propylene Glycol 0.6% eye drops

Study type

Interventional

Funder types

Industry

Identifiers

NCT02511379

EXJ821-P001 (C-13-039)

CTRI/2015/10/006320 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

This study was conducted in India.

Enrollment

14 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Sign informed consent and willing and able to attend all study visits;
Dry eye in both eyes diagnosed by an ophthalmologist;
Other protocol-specified inclusion criteria may apply.

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;
Other protocol-specified exclusion criteria may apply.