Systane Family - Meibomian Deficiency
The purpose of this study is 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.
Dry Eye Syndrome
Other: Systane Lid Wipes
Other: SYSTANE BALANCE Lubricant Eye Drops
Dietary Supplement: Systane Vitamins
Other: Microfiber towels
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||Systane Family Efficacy in Meibomian Gland Functionality for Lipid Deficient Evaporative Dry Eye Subjects|
- Meibomian Glands Yielding Liquid Secretion (MGLYS) [ Time Frame: Month 3 ] [ Designated as safety issue: No ]Meibomian gland functionality will be 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 number of meibomian gland orificies evidencing liquid secretion during expression with the MGE will be documented.
- Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses [ Time Frame: Month 3 ] [ Designated as safety issue: No ]The Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire is a 16-question validated questionnaire that measures the frequency and severity of dry eye symptoms. The SPEED questionnaire will be completed by the patient with no assistance from the office staff, physician, or anyone else.
- Dry Eye Ocular Surface Disease Index (OSDI) Questionnaire Responses [ Time Frame: Month 3 ] [ Designated as safety issue: No ]The Dry Eye OSDI Questionnaire is a 12-question validated questionnaire (resultant overall 0-100 score) that measures ocular symptoms, visual function, and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire will be completed by the patient with no assistance from the office staff, physician, or anyone else.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: Systane Family
Systane Lid Wipes administered to treated eye(s) twice a day; Systane Balance lubricant eye drops administered to treated eye(s), one drop four times a day; Systane Vitamins, two softgels ingested daily. Duration of treatment is 3 months.
Other: Systane Lid Wipes
Systane Lid Wipes pre-moistened eyelid cleansing wipes for topical ocular external scrubbing of eyelids and eyelashes
Other Name: SYSTANE™ LID WIPESOther: SYSTANE BALANCE Lubricant Eye Drops
Other Name: SYSTANE® BALANCEDietary Supplement: Systane Vitamins
Other Name: SYSTANE™ Vitamin Omega-3 Supplement
Active Comparator: Standard of Care
Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, one time a day. Duration of treatment is 3 months.
|Other: Microfiber towels|
|Contact: Alcon Call Center||1-888-451-3937|
|United States, Texas|
|Contact Alcon Call Center for Trial Locations||Recruiting|
|Fort Worth, Texas, United States, 76134|
|Study Director:||Beth Scott, O.D., MS, FAAO||Alcon Research|
|Principal Investigator:||Donald R Korb, O.D.||Korb and Associates|