Clinical Evaluation of Systane® Balance in Dry Eye Subjects

Not Applicable

Terminated

• Conditions: Dry Eye
• Interventions: Other: Propylene Glycol 0.6% eye drops

• Registration Number: NCT02511379
• Lead Sponsor: Alcon Research

Brief Summary

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.

Detailed Description

This study was conducted in India.

Study Timeline

• Study First Submitted: 2015-07-28
• Study First Submitted QC: 2015-07-28
• Study First Posted: 2015-07-30
• Study Start: 2015-11-26
• Primary Completion: 2016-06-20
• Study Completion: 2016-06-20
• Results First Submitted: 2017-12-15
• Results First Submitted QC: 2017-12-15
• Results First Posted: 2018-09-05
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-03
• Last Update Posted: 2018-10-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Corneal Staining Total Score	Baseline (Day 0), Day 45, Day 90	The type (severity) of staining was assessed for each of the 5 regions of the cornea (central, inferior, temporal, superior, and nasal) and graded on a 4-point scale, where 0 = Normal (No staining) and 3 = Severe (Numerous coalescent macropunctate areas and/or patches). The scores of the 5 regions were summed to obtain a corneal staining total score for each eye (minimum 0, maximum 15).