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

Alcon

Status: Completed

Conditions: Dry Eye Syndrome

Treatments: Other: Microfiber towels (as warm compresses, with or without saline eye drops); Dietary Supplement: SYSTANE® Vitamins; Other: SYSTANE® Lid Wipes; Other: SYSTANE® BALANCE

Study type: Interventional

Funder types: Industry

Identifiers

NCT01733745

A00978

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups

SYSTANE® Family

Experimental group

Description:

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.

Treatment:

Dietary Supplement: SYSTANE® Vitamins

Other: SYSTANE® BALANCE

Other: SYSTANE® Lid Wipes

Standard of Care

Active Comparator group

Description:

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.

Treatment:

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