SYSTANE® Family - Meibomian Deficiency

NCT ID: NCT01733745

Last Updated: 2018-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-06-30

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.

Conditions

Dry Eye Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

SYSTANE® Lid Wipes

Intervention Type: OTHER

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

SYSTANE® BALANCE

Intervention Type: OTHER

Lubricant Eye Drops

SYSTANE® Vitamins

Intervention Type: DIETARY_SUPPLEMENT

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

Interventions

SYSTANE® Lid Wipes

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

Intervention Type: OTHER

SYSTANE® BALANCE

Lubricant Eye Drops

Intervention Type: OTHER

SYSTANE® Vitamins

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: OTHER

Other Intervention Names

SYSTANE® Vitamin Omega-3 Supplement

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;

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Danyel C. Carr, MS, CCRA

Role: STUDY_DIRECTOR

Alcon Research

Donald R Korb, O.D.

Role: PRINCIPAL_INVESTIGATOR

Korb and Associates

Other Identifiers

A00978

Identifier Type: -

Identifier Source: org_study_id