SYSTANE® Family - Meibomian Deficiency (M-12-077)
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.
Dry Eye Syndrome
Other: SYSTANE® Lid Wipes
Other: SYSTANE® BALANCE
Dietary Supplement: SYSTANE® Vitamins
Other: Microfiber towels (as warm compresses, with or without saline eye drops)
|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|
- Number of Meibomian Glands Yielding Liquid Secretion (MGLYS) [ Time Frame: Baseline, Month 1, Month 2, Month 3 ] [ Designated as safety issue: No ]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.
- Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses [ Time Frame: Baseline, Month 1, Month 2, Month 3 ] [ Designated as safety issue: No ]The Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire is a 16-question validated questionnaire (resultant overall score 0-28, with 0 being best and 28 being worst) that measures the frequency and severity of dry eye symptoms. The SPEED questionnaire was completed by the patient with no assistance from the office staff, physician, or anyone else. Both eyes contributed to the mean.
- Dry Eye Ocular Surface Disease Index (OSDI) Questionnaire Responses [ Time Frame: Baseline, Month 1, Month 2, Month 3 ] [ Designated as safety issue: No ]The Dry Eye OSDI Questionnaire is a 12-question validated questionnaire [resultant overall 0-100 score, with 0 being none of the time (best) and 100 being all of the time (worst)] that measures ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The OSDI questionnaire was completed by the patient with no assistance from the office staff, physician, or anyone else. Both eyes contributed to the mean.
|Study Start Date:||February 2013|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: 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.
Other: SYSTANE® Lid Wipes
Pre-moistened eyelid cleansing wipes for topical ocular external scrubbing of eyelids and eyelashesOther: SYSTANE® BALANCE
Lubricant Eye DropsDietary Supplement: SYSTANE® Vitamins
Other Name: SYSTANE® Vitamin Omega-3 Supplement
Active Comparator: 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.
|Other: Microfiber towels (as warm compresses, with or without saline eye drops)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733745
|Study Director:||Danyel C. Carr, MS, CCRA||Alcon Research|
|Principal Investigator:||Donald R Korb, O.D.||Korb and Associates|