SYSTANE® BALANCE Symptoms (OSDI) & Inflammatory Biomarkers

Alcon

Status: Completed

Conditions: Dry Eye Syndrome

Treatments: Other: SYSTANE® Gel; Other: SYSTANE® BALANCE Lubricant Eye Drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT01733732

A00976

Details and patient eligibility

About

The purpose of this study is to evaluate the ability of SYSTANE® BALANCE and SYSTANE® Gel to improve comfort in subjects with dry eyes.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Read, sign, and date the Informed Consent Document;
• Must not have used any topical ocular drops for approximately 24 hours prior to Visit 1;
• Meet the protocol-specified dry eye criteria at Screening Visit (Visit 1);
• Intraocular pressure (IOP) less than or equal to 22 millimeters of mercury (mmHg) in both eyes;
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• History or evidence of ocular or intraocular surgery or serious trauma in either eye within the past 6 months;
• Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs);
• History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye;
• Use of any concomitant topical ocular medications during the study period;
• Currently using Restasis but unwilling to discontinue its use 1 month prior to screening and for the entire study period;
• Use of systemic medications that may contribute to dry eye unless on a stable dosing regimen for a minimum of 30 days prior to Visit 1 and that remains stable throughout the study;
• Uncontrolled ocular conditions such as uveitis, glaucoma or any other ocular condition that may preclude the safe administration of either drop under investigation;
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 2 patient groups

Systane Balance

Experimental group

Description:

SYSTANE® BALANCE Lubricant Eye Drops, 1 drop in each eye 4 times a day for 30 days

Treatment:

Other: SYSTANE® BALANCE Lubricant Eye Drops

Systane Gel

Active Comparator group

Description:

SYSTANE® Gel, 1 drop in each eye 4 times a day for 30 days

Treatment:

Other: SYSTANE® Gel