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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01688726
First received: September 17, 2012
Last updated: November 18, 2014
Last verified: November 2014
  Purpose

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 Intervention
Dry Eye Syndrome
Lipid Deficiency
Other: SYSTANE® BALANCE eyedrops
Other: Minims® Saline 0.9% eyedrops

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Bulbar Conjunctival Staining [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 91
Study Start Date: December 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01688726

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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01688726     History of Changes
Other Study ID Numbers: A00977
Study First Received: September 17, 2012
Results First Received: November 11, 2014
Last Updated: November 18, 2014
Health Authority: United Kingdom: Research Ethics Committee

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:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Conjunctival Diseases
Conjunctivitis
Corneal Diseases
Eye Diseases
Keratitis
Keratoconjunctivitis
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Tetrahydrozoline
Autonomic Agents
Cardiovascular Agents
Nasal Decongestants
Peripheral Nervous System Agents
Pharmaceutical Solutions
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sympathomimetics
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on November 20, 2014