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Evaluation of SYSTANE® BALANCE in Dry Eye Subjects With Lipid Deficiency

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ClinicalTrials.gov Identifier: NCT01688726
Recruitment Status : Completed
First Posted : September 20, 2012
Results First Posted : November 18, 2014
Last Update Posted : November 19, 2014
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndrome Lipid Deficiency Other: SYSTANE® BALANCE eyedrops Other: Minims® Saline 0.9% eyedrops Not Applicable

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Sponsors and Collaborators
Alcon Research
Investigators
Principal Investigator: Michel Guillon, PhD, FCOptom, FAAO, CCTI OTG Research & Consultancy
More Information
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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