SYSTANE® Family - Meibomian Deficiency (M-12-077)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01733745
First received: November 21, 2012
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

The purpose of this study was 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
Dietary Supplement: SYSTANE® Vitamins
Other: Microfiber towels (as warm compresses, with or without saline eye drops)

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:
  • Number of Meibomian Glands Yielding Liquid Secretion (MGLYS) [ Time Frame: Baseline, Month 1, Month 2, Month 3 ] [ Designated as safety issue: No ]
    Meibomian gland functionality was 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 total number of meibomian gland orificies evidencing liquid secretion during expression with the MGE, in both eyes, was recorded. A lower number of functioning meibomian glands may contribute to dry eye syndrome.


Secondary Outcome Measures:
  • Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses [ Time Frame: Baseline, Month 1, Month 2, Month 3 ] [ Designated as safety issue: No ]
    The Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire is a 16-question validated questionnaire (resultant overall score 0-28, with 0 being best and 28 being worst) that measures the frequency and severity of dry eye symptoms. The SPEED questionnaire was completed by the patient with no assistance from the office staff, physician, or anyone else. Both eyes contributed to the mean.

  • Dry Eye Ocular Surface Disease Index (OSDI) Questionnaire Responses [ Time Frame: Baseline, Month 1, Month 2, Month 3 ] [ Designated as safety issue: No ]
    The Dry Eye OSDI Questionnaire is a 12-question validated questionnaire [resultant overall 0-100 score, with 0 being none of the time (best) and 100 being all of the time (worst)] that measures ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The OSDI questionnaire was completed by the patient with no assistance from the office staff, physician, or anyone else. Both eyes contributed to the mean.


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) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.
Other: SYSTANE® Lid Wipes
Pre-moistened eyelid cleansing wipes for topical ocular external scrubbing of eyelids and eyelashes
Other: SYSTANE® BALANCE
Lubricant Eye Drops
Dietary Supplement: SYSTANE® Vitamins
Other Name: SYSTANE® Vitamin Omega-3 Supplement
Active Comparator: Standard of Care
Microfiber towels (as warm compresses, with or without saline eye drops) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
Other: Microfiber towels (as warm compresses, with or without saline eye drops)

  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 20/40 Snellen 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 6 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 1 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
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: NCT01733745

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Danyel C. Carr, MS, CCRA 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
Results First Received: June 2, 2014
Last Updated: July 2, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 16, 2014