SYSTANE® Family - Meibomian Deficiency

NCT01733745 | Completed Results

• 1 other identifier: A00978
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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

Keywords

dry eye; lipid deficiency; meibomian gland

Outcome Measures

Primary Outcomes (1)

• Number of Meibomian Glands Yielding Liquid Secretion (MGLYS)

  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.

  Baseline, Month 1, Month 2, Month 3

Secondary Outcomes (2)

• Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses

  Baseline, Month 1, Month 2, Month 3

• Dry Eye Ocular Surface Disease Index (OSDI) Questionnaire Responses

  Baseline, Month 1, Month 2, Month 3

Study Arms (2)

SYSTANE® Family

EXPERIMENTAL

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; Other: SYSTANE® BALANCE; Dietary Supplement: SYSTANE® Vitamins

Standard of Care

ACTIVE COMPARATOR

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)

Interventions

SYSTANE® Lid Wipes OTHER

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

SYSTANE® Family

SYSTANE® BALANCE OTHER

Lubricant Eye Drops

SYSTANE® Family

SYSTANE® Vitamins DIETARY_SUPPLEMENT

Also known as: SYSTANE® Vitamin Omega-3 Supplement

SYSTANE® Family

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

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Abayomi Ogundele, Pharm.D, Global Brand Medical Affairs Lead
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Danyel C. Carr, MS, CCRA

  Alcon Research

  STUDY DIRECTOR

• Donald R Korb, O.D.

  Korb and Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2012
• First Posted: November 27, 2012
• Study Start: February 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 29, 2018
• Results First Posted: July 3, 2014

Record last verified: 2013-09