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

Dry Eye Clinical Trial

Official title:

The Effect of SYSTANE® BALANCE on Non-Invasive Tear Film Break Up Time (NITFBUT) in Dry Eye Subjects With Lipid Deficiency Following 30 Days of Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01718028
• Other study ID #: RDG-11-262
• Status: Completed
• Phase: N/A
• First received: October 29, 2012
• Last updated: November 15, 2013
• Start date: September 2012
• Est. completion date: October 2012

Study information

• Verified date: November 2013
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Human Research Bioethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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;

• Other protocol-defined inclusion criteria may apply.

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;

• Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Other:
• Propylene glycol 0.6% ocular emulsion

• Sodium chloride 0.9% saline solution

Locations

Country	Name	City	State
Argentina	Consultório Oftalmológico	Martinez	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Mean Change From Baseline in NITFBUT at Day 14	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 14	No
Secondary	Mean NITFBUT by Visit	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 longer tear film break-up time indicates a more stable tear film, which may improve dry eye symptoms in dry eye sufferers.	Baseline (Day 0), Day 14, Day 30	No
Secondary	Percent Change From Baseline in NITFBUT by Visit	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. The percentage of participants with a lengthening in tear film break up time relative to baseline is reported. A positive value indicates an improvement in film stability, which may improve dry eye symptoms in dry eye sufferers.	Baseline (Day 0), Day 14, Day 30	No