Clinical Evaluation of Systane® Balance in Dry Eye Subjects

Clinical Evaluation of Systane® Balance on Corneal Staining in Indian Subjects With Dry Eye

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.

Study Overview

• Status: Terminated
• Conditions: Dry Eye
• Intervention / Treatment: Other: Propylene Glycol 0.6% eye drops

Detailed Description

This study was conducted in India.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: Propylene Glycol 0.6% eye drops; Other Names: Systane® Balance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Corneal Staining Total Score	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).	Baseline (Day 0), Day 45, Day 90

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Alcon Research, Ltd, Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2015
• Primary Completion (Actual): June 20, 2016
• Study Completion (Actual): June 20, 2016

Study Registration Dates

• First Submitted: July 28, 2015
• First Submitted That Met QC Criteria: July 28, 2015
• First Posted (Estimate): July 30, 2015

Study Record Updates

• Last Update Posted (Actual): October 31, 2018
• Last Update Submitted That Met QC Criteria: October 3, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: EXJ821-P001 (C-13-039); CTRI/2015/10/006320 (Registry Identifier: CTRI)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No