The Effect of SYSTANE® BALANCE on Tear Film Break Up Time in Dry Eye Subjects

NCT ID: NCT01718028

Last Updated: 2014-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2012-10-31

Brief Summary

The purpose of this study was to evaluate the ability of SYSTANE® BALANCE dosed 4 times a day for 30 days to increase non-invasive tear film break up time over baseline, compared to a saline control, in dry eye subjects with lipid deficiency.

Conditions

Dry Eye

Study Design

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

Study Groups

SYSTANE® BALANCE

Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days

Group Type: EXPERIMENTAL

Propylene glycol 0.6% ocular emulsion

Intervention Type: OTHER

LARMABAK®

Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days

Group Type: ACTIVE_COMPARATOR

Sodium chloride 0.9% saline solution

Intervention Type: OTHER

Interventions

Propylene glycol 0.6% ocular emulsion

Intervention Type: OTHER

Sodium chloride 0.9% saline solution

Intervention Type: OTHER

Other Intervention Names

SYSTANE® BALANCE; LARMABAK®

Eligibility Criteria

Inclusion Criteria

• Read, sign, and date an information consent;
• Willing and able to follow instructions and maintain the appointment schedule;
• Best-corrected visual acuity of 0.6 logMAR or better in each eye as assessed at Visit 1;
• Must not have used any topical ocular drops for approximately 24 hours prior to Visit 1;
• Meet protocol-specified criteria for dry eye at Visit 1;

Exclusion Criteria

• History or evidence of ocular or intraocular surgery or serious ocular trauma in either eye within the past six months;
• Current punctal occlusion of any type (e.g., collagen plugs, silicon plugs);
• History of intolerance or hypersensitivity to any component of the study medications;
• 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;
• 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;
• Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of either drop under investigation;
• Unwilling to discontinue contact lens wear during the study period. Contact lens wear must have been discontinued at least one week prior to Visit 1.
• Participation in an investigational drug or device study within 30 days of entering this study;

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

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Consultório Oftalmológico

Martínez, Buenos Aires, Argentina

Countries

Argentina

Other Identifiers

RDG-11-262

Identifier Type: -

Identifier Source: org_study_id