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

NCT01718028 | Completed Results

• 1 other identifier: RDG-11-262
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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

Keywords

Systane BALANCE; Dry eye; lipid deficiency; NITFBUT

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in NITFBUT at Day 30

  NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A positive change value indicates an improvement in tear film stability, which may improve dry eye symptoms in dry eye sufferers.

  Baseline (Day 0), Day 30

Secondary Outcomes (3)

• Mean Change From Baseline in NITFBUT at Day 14

  Baseline (Day 0), Day 14

• Mean NITFBUT by Visit

  Baseline (Day 0), Day 14, Day 30

• Percent Change From Baseline in NITFBUT by Visit

  Baseline (Day 0), Day 14, Day 30

Study Arms (2)

SYSTANE® BALANCE

EXPERIMENTAL

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

Other: Propylene glycol 0.6% ocular emulsion

LARMABAK®

ACTIVE COMPARATOR

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

Other: Sodium chloride 0.9% saline solution

Interventions

Propylene glycol 0.6% ocular emulsion OTHER

Also known as: SYSTANE® BALANCE

SYSTANE® BALANCE

Sodium chloride 0.9% saline solution OTHER

Also known as: LARMABAK®

LARMABAK®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Consultório Oftalmológico

Martínez, Buenos Aires, Argentina

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Propylene Glycol; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Propylene Glycols; Glycols; Alcohols; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Abayomi Ogundele, Pharm.D.
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2012
• First Posted: October 31, 2012
• Study Start: September 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: January 6, 2014
• Results First Posted: January 6, 2014

Record last verified: 2013-11

Locations

AR (1)