SYSTANE® BALANCE Symptoms (OSDI) & Inflammatory Biomarkers

NCT ID: NCT01733732

Last Updated: 2018-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-10-31

Brief Summary

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

Conditions

Dry Eye Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Systane Balance

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

Group Type: EXPERIMENTAL

SYSTANE® BALANCE Lubricant Eye Drops

Intervention Type: OTHER

Systane Gel

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

Group Type: ACTIVE_COMPARATOR

SYSTANE® Gel

Intervention Type: OTHER

Interventions

SYSTANE® BALANCE Lubricant Eye Drops

Intervention Type: OTHER

SYSTANE® Gel

Intervention Type: OTHER

Other Intervention Names

SYSTANE® BALANCE

Eligibility Criteria

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;

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abayomi Ogundele, PharmD

Role: STUDY_DIRECTOR

Alcon Research

Penny A. Asbell, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Other Identifiers

A00976

Identifier Type: -

Identifier Source: org_study_id