- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01718028
The Effect of SYSTANE® BALANCE on Tear Film Break Up Time in Dry Eye Subjects
November 15, 2013 updated by: Alcon Research
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Buenos Aires
-
Martinez, Buenos Aires, Argentina
- Consultório Oftalmológico
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SYSTANE® BALANCE
Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
|
Other Names:
|
Active Comparator: LARMABAK®
Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change From Baseline in NITFBUT at Day 30
Time Frame: Baseline (Day 0), 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change From Baseline in NITFBUT at Day 14
Time Frame: Baseline (Day 0), 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
|
Mean NITFBUT by Visit
Time Frame: Baseline (Day 0), Day 14, 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 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
|
Percent Change From Baseline in NITFBUT by Visit
Time Frame: Baseline (Day 0), Day 14, 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.
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
October 29, 2012
First Submitted That Met QC Criteria
October 29, 2012
First Posted (Estimate)
October 31, 2012
Study Record Updates
Last Update Posted (Estimate)
January 6, 2014
Last Update Submitted That Met QC Criteria
November 15, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RDG-11-262
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dry Eye
-
Gordon Schanzlin New VisionCompletedDry Eye | Dry Eye Disease | Evaporative Dry Eye | Kerato Conjunctivitis Sicca | Evaporative Dry Eye Disease | Dry Eye, EvaporativeUnited States
-
Kao (Taiwan) CorporationChang Gung Memorial HospitalCompletedEye Fatigue | Dry Eye SymptomTaiwan
-
Senju Pharmaceutical Co., Ltd.CompletedDry Eye Syndrome | Dry Eye DiseaseUnited States
-
Alcon ResearchCompletedVisual Performance | Dry Eye Symptoms
-
Alcon ResearchCompletedModerate to Severe Dry Eye
-
Singapore National Eye CentreCompleted
-
Bausch & Lomb IncorporatedCompletedDry Eye Disease (DED)United States
-
AllerganCompletedDry Eye Syndrome | Dry Eye DiseaseUnited States
-
Centre for Contact Lens ResearchCoopervision, Inc.CompletedContact Lens Related Dry EyeCanada
-
Singapore National Eye CentreCompleted
Clinical Trials on Propylene glycol 0.6% ocular emulsion
-
Laboratorios Sophia S.A de C.V.Completed
-
Alcon ResearchCompleted
-
Alcon ResearchCompleted