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OpenTrials
Completed

NCT Number: NCT01733745

SYSTANE® Family - Meibomian Deficiency

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Systane® Lid Wipes

Other

Pre-moistened eyelid cleansing wipes for topical ocular external scrubbing of eyelids and eyelashes

SYSTANE® BALANCE

Other

Lubricant Eye Drops

SYSTANE® Vitamins

Dietary Supplement

Other names: SYSTANE® Vitamin Omega-3 Supplement

Microfiber towels (as warm compresses, with or without saline eye drops)

Other

Primary outcomes

  1. Number of Meibomian Glands Yielding Liquid Secretion (MGLYS)

    Time frame: Baseline, Month 1, Month 2, Month 3

    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 outcomes

  1. Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses

    Time frame: Baseline, Month 1, Month 2, Month 3

    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.

  2. Dry Eye Ocular Surface Disease Index (OSDI) Questionnaire Responses

    Time frame: Baseline, Month 1, Month 2, Month 3

    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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

SYSTANE® Family Efficacy in Meibomian Gland Functionality for Lipid Deficient Evaporative Dry Eye Subjects

Acronym: M-12-077

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Nov 27, 2012
Registry last updated
Jun 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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