Back to resultsEvaluation of SYSTANE® BALANCE in Dry Eye Subjects With Lipid Deficiency
Primary Purpose
Dry Eye Syndrome, Lipid Deficiency
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SYSTANE® BALANCE eyedrops
Minims® Saline 0.9% eyedrops
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndrome focused on measuring Dry eye, Ocular surface, Vision complaint, Tear film stability, Time controlled functional visual acuity, Tear film kinetics
Eligibility Criteria
Inclusion Criteria:
- Non-contact lens wearer;
- Symptomatology as defined by the Ocular Surface Disease Index (OSDI) questionnaire;
- Lipid deficiency;
- Best visual acuity of 6/9 or better in each eye;
- Willingness to adhere to the instructions set in the clinical protocol;
- Signature of the subject informed consent form;
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Use of systemic medication which might produce dry eye side effects;
- Systemic disease which might produce dry eye side effects;
- Active or recent ocular inflammation or infection;
- Use of ocular medication;
- Significant ocular anomaly;
- Previous ocular surgery;
- Previous use of Restasis;
- Any medical condition that might be prejudicial to the study;
- Pregnant or lactating;
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SYSTANE BALANCE
Minims Saline
Arm Description
SYSTANE® BALANCE eyedrops, 1 drop 4 times a day for a continuous period of 1 month
Minims® Saline 0.9% eyedrops, 1 drop 4 times a day for a continuous period of 1 month
Outcomes
Primary Outcome Measures
Mean Bulbar Conjunctival Staining
The conjunctival staining present in the bulbar area was evaluated 120 minutes post eyedrop instillation using a slit lamp with digital image capture and lissamine green strips. Staining coverage as a percentage of the exposed bulbar conjunctiva is reported. A lower percentage in staining area represents a better outcome.
Secondary Outcome Measures
High Contrast logMAR Time Controlled Visual Acuity (TCVA)
TCVA (functional visual performance) was measured with both eyes together under controlled lighting, contrast and temporal conditions using the OTG computerized vision testing system prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation with the subject's up-to-date vision correction in place. TCVA is measured in logarithm of the minimum angle of resolution (logMAR), with logMAR acuity of 0.0 considered normal distance eyesight. A negative logMAR value denotes better visual acuity.
Non Invasive Tear Film Break-up-time (NIBUT)
NIBUT was measured prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation. The time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film as observed with a specialized illumination source was recorded. A higher number represents a lengthening in the tear film break up time and greater perceived ocular comfort.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01688726
Brief Title
Evaluation of SYSTANE® BALANCE in Dry Eye Subjects With Lipid Deficiency
Official Title
Evaluation of SYSTANE® BALANCE on Conjunctival Staining (CS) Visual Performance (VP) and Tear Film Kinetics (TFK) in Dry Eye Subjects With Lipid Deficiency
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the repeated use of SYSTANE® BALANCE on stabilizing the tear film of dry eye patients with an unstable tear film.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome, Lipid Deficiency
Keywords
Dry eye, Ocular surface, Vision complaint, Tear film stability, Time controlled functional visual acuity, Tear film kinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SYSTANE BALANCE
Arm Type
Experimental
Arm Description
SYSTANE® BALANCE eyedrops, 1 drop 4 times a day for a continuous period of 1 month
Arm Title
Minims Saline
Arm Type
Active Comparator
Arm Description
Minims® Saline 0.9% eyedrops, 1 drop 4 times a day for a continuous period of 1 month
Intervention Type
Other
Intervention Name(s)
SYSTANE® BALANCE eyedrops
Intervention Type
Other
Intervention Name(s)
Minims® Saline 0.9% eyedrops
Primary Outcome Measure Information:
Title
Mean Bulbar Conjunctival Staining
Description
The conjunctival staining present in the bulbar area was evaluated 120 minutes post eyedrop instillation using a slit lamp with digital image capture and lissamine green strips. Staining coverage as a percentage of the exposed bulbar conjunctiva is reported. A lower percentage in staining area represents a better outcome.
Time Frame
Month 1
Secondary Outcome Measure Information:
Title
High Contrast logMAR Time Controlled Visual Acuity (TCVA)
Description
TCVA (functional visual performance) was measured with both eyes together under controlled lighting, contrast and temporal conditions using the OTG computerized vision testing system prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation with the subject's up-to-date vision correction in place. TCVA is measured in logarithm of the minimum angle of resolution (logMAR), with logMAR acuity of 0.0 considered normal distance eyesight. A negative logMAR value denotes better visual acuity.
Time Frame
Month 1
Title
Non Invasive Tear Film Break-up-time (NIBUT)
Description
NIBUT was measured prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation. The time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film as observed with a specialized illumination source was recorded. A higher number represents a lengthening in the tear film break up time and greater perceived ocular comfort.
Time Frame
Month 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Non-contact lens wearer;
Symptomatology as defined by the Ocular Surface Disease Index (OSDI) questionnaire;
Lipid deficiency;
Best visual acuity of 6/9 or better in each eye;
Willingness to adhere to the instructions set in the clinical protocol;
Signature of the subject informed consent form;
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Use of systemic medication which might produce dry eye side effects;
Systemic disease which might produce dry eye side effects;
Active or recent ocular inflammation or infection;
Use of ocular medication;
Significant ocular anomaly;
Previous ocular surgery;
Previous use of Restasis;
Any medical condition that might be prejudicial to the study;
Pregnant or lactating;
Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Guillon, PhD, FCOptom, FAAO, CCTI
Organizational Affiliation
OTG Research & Consultancy
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Evaluation of SYSTANE® BALANCE in Dry Eye Subjects With Lipid Deficiency
We'll reach out to this number within 24 hrs