SYSTANE® Family - Meibomian Deficiency (M-12-077)
|ClinicalTrials.gov Identifier: NCT01733745|
Recruitment Status : Completed
First Posted : November 27, 2012
Results First Posted : July 3, 2014
Last Update Posted : July 15, 2014
|Condition or disease||Intervention/treatment||Phase|
|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)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||SYSTANE® Family Efficacy in Meibomian Gland Functionality for Lipid Deficient Evaporative Dry Eye Subjects|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
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 eyelashes
Other: SYSTANE® BALANCE
Lubricant Eye Drops
Dietary 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)
- Number of Meibomian Glands Yielding Liquid Secretion (MGLYS) [ Time Frame: Baseline, Month 1, Month 2, Month 3 ]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 ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01733745
|Study Director:||Danyel C. Carr, MS, CCRA||Alcon Research|
|Principal Investigator:||Donald R Korb, O.D.||Korb and Associates|