Evaluation of SYSTANE® BALANCE in Dry Eye Subjects With Lipid Deficiency
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01688726 |
Recruitment Status
:
Completed
First Posted
: September 20, 2012
Results First Posted
: November 18, 2014
Last Update Posted
: November 19, 2014
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dry Eye Syndrome Lipid Deficiency | Other: SYSTANE® BALANCE eyedrops Other: Minims® Saline 0.9% eyedrops | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 91 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
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 Start Date : | December 2012 |
Actual Primary Completion Date : | November 2013 |
Actual Study Completion Date : | November 2013 |
Arm | Intervention/treatment |
---|---|
Experimental: SYSTANE BALANCE
SYSTANE® BALANCE eyedrops, 1 drop 4 times a day for a continuous period of 1 month
|
Other: SYSTANE® BALANCE eyedrops |
Active Comparator: Minims Saline
Minims® Saline 0.9% eyedrops, 1 drop 4 times a day for a continuous period of 1 month
|
Other: Minims® Saline 0.9% eyedrops |
- Mean Bulbar Conjunctival Staining [ Time Frame: Month 1 ]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.
- High Contrast logMAR Time Controlled Visual Acuity (TCVA) [ Time Frame: Month 1 ]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) [ Time Frame: Month 1 ]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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01688726
Principal Investigator: | Michel Guillon, PhD, FCOptom, FAAO, CCTI | OTG Research & Consultancy |
Responsible Party: | Alcon Research |
ClinicalTrials.gov Identifier: | NCT01688726 History of Changes |
Other Study ID Numbers: |
A00977 |
First Posted: | September 20, 2012 Key Record Dates |
Results First Posted: | November 18, 2014 |
Last Update Posted: | November 19, 2014 |
Last Verified: | November 2014 |
Keywords provided by Alcon Research:
Dry eye Ocular surface Vision complaint |
Tear film stability Time controlled functional visual acuity Tear film kinetics |
Additional relevant MeSH terms:
Keratoconjunctivitis Sicca Dry Eye Syndromes Keratoconjunctivitis Conjunctivitis Conjunctival Diseases Eye Diseases Keratitis Corneal Diseases Lacrimal Apparatus Diseases Ophthalmic Solutions |
Tetrahydrozoline Pharmaceutical Solutions Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Nasal Decongestants Vasoconstrictor Agents Respiratory System Agents |