Clinical trial NCT01733745: SYSTANE® Family - Meibomian Deficiency
Official title: SYSTANE® Family Efficacy in Meibomian Gland Functionality for Lipid Deficient Evaporative Dry Eye Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndrome
Keywords: dry eye
lipid deficiency
meibomian gland
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2012-11-27
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Number of Meibomian Glands Yielding Liquid Secretion (MGLYS)
timeFrame: Baseline, Month 1, Month 2, Month 3
Secondary outcomes:
measure: Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Dry Eye Ocular Surface Disease Index (OSDI) Questionnaire Responses
timeFrame: Baseline, Month 1, Month 2, Month 3
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Danyel C. Carr, MS, CCRA
role: STUDY_DIRECTOR
affiliation: Korb and Associates
name: Donald R Korb, O.D.
role: PRINCIPAL_INVESTIGATOR
References: