Systane Family - Meibomian Deficiency

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01733745
First received: November 21, 2012
Last updated: September 26, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to assess the efficacy of the Systane family of products (Systane Lid Wipes, Systane Balance Lubricant Eye Drops, and Systane Vitamins) on meibomian gland functionality in subjects with lipid deficiency related to evaporative dry eye as compared to the standard of care warm compresses.


Condition Intervention
Dry Eye Syndrome
Other: Systane Lid Wipes
Other: SYSTANE BALANCE Lubricant Eye Drops
Dietary Supplement: Systane Vitamins
Other: Microfiber towels

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Systane Family Efficacy in Meibomian Gland Functionality for Lipid Deficient Evaporative Dry Eye Subjects

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Meibomian Glands Yielding Liquid Secretion (MGLYS) [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Meibomian gland functionality will be evaluated by the investigator using the Meibomian Gland Evaluator (MGE), a handheld instrument that provides a standardized method for applying consistent, gentle pressure to the outer skin of the lower eyelid. The number of meibomian gland orificies evidencing liquid secretion during expression with the MGE will be documented.


Secondary Outcome Measures:
  • Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    The Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire is a 16-question validated questionnaire that measures the frequency and severity of dry eye symptoms. The SPEED questionnaire will be completed by the patient with no assistance from the office staff, physician, or anyone else.

  • Dry Eye Ocular Surface Disease Index (OSDI) Questionnaire Responses [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    The Dry Eye OSDI Questionnaire is a 12-question validated questionnaire (resultant overall 0-100 score) that measures ocular symptoms, visual function, and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire will be completed by the patient with no assistance from the office staff, physician, or anyone else.


Enrollment: 26
Study Start Date: February 2013
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Systane Family
Systane Lid Wipes administered to treated eye(s) twice a day; Systane Balance lubricant eye drops administered to treated eye(s), one drop four times a day; Systane Vitamins, two softgels ingested daily. Duration of treatment is 3 months.
Other: Systane Lid Wipes
Systane Lid Wipes pre-moistened eyelid cleansing wipes for topical ocular external scrubbing of eyelids and eyelashes
Other Name: SYSTANE™ LID WIPES
Other: SYSTANE BALANCE Lubricant Eye Drops
Other Name: SYSTANE® BALANCE
Dietary Supplement: Systane Vitamins
Other Name: SYSTANE™ Vitamin Omega-3 Supplement
Active Comparator: Standard of Care
Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, one time a day. Duration of treatment is 3 months.
Other: Microfiber towels

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have a clinical diagnosis of lipid deficient Evaporative Dry Eye;
  • Meibomian Gland Functionality - Not more than 6 glands yielding liquid secretion;
  • Must be willing to discontinue the use of all other Meibomian Gland Dysfunction management prior to receiving the study test article at Visit 1, up until the end of the study period;
  • Must have best corrected visual acuity of 6/60 (20/20 Snellen, 1.0 logMAR) or better in each eye;
  • Must be able to follow instructions and be willing and able to attend required study visits;
  • Must read, sign, and date an Ethics Committee reviewed and approved informed consent form;
  • 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, silicone 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.
  • Pregnant or lactating at the time of enrollment;
  • Not willing to take adequate precautions not to become pregnant during the study;
  • 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 that may preclude the safe administration of either drop under investigation;
  • Unwilling to discontinue contact lens wear during the study period and for 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733745

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Beth Scott, O.D., MS, FAAO Alcon Research
Principal Investigator: Donald R Korb, O.D. Korb and Associates
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01733745     History of Changes
Other Study ID Numbers: A00978
Study First Received: November 21, 2012
Last Updated: September 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
dry eye
lipid deficiency
meibomian gland

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Tetrahydrozoline
Vitamins
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 17, 2014