Back to resultsSYSTANE® Family - Meibomian Deficiency (M-12-077)
Primary Purpose
Dry Eye Syndrome
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SYSTANE® Lid Wipes
SYSTANE® BALANCE
SYSTANE® Vitamins
Microfiber towels (as warm compresses, with or without saline eye drops)
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndrome focused on measuring dry eye, lipid deficiency, meibomian gland
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;
- Other protocol-defined inclusion criteria may apply.
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;
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SYSTANE® Family
Standard of Care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01733745
Brief Title
SYSTANE® Family - Meibomian Deficiency
Acronym
M-12-077
Official Title
SYSTANE® Family Efficacy in Meibomian Gland Functionality for Lipid Deficient Evaporative Dry Eye Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome
Keywords
dry eye, lipid deficiency, meibomian gland
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SYSTANE® Family
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
SYSTANE® Lid Wipes
Intervention Description
Pre-moistened eyelid cleansing wipes for topical ocular external scrubbing of eyelids and eyelashes
Intervention Type
Other
Intervention Name(s)
SYSTANE® BALANCE
Intervention Description
Lubricant Eye Drops
Intervention Type
Dietary Supplement
Intervention Name(s)
SYSTANE® Vitamins
Other Intervention Name(s)
SYSTANE® Vitamin Omega-3 Supplement
Intervention Type
Other
Intervention Name(s)
Microfiber towels (as warm compresses, with or without saline eye drops)
Primary Outcome Measure Information:
Title
Number of Meibomian Glands Yielding Liquid Secretion (MGLYS)
Description
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.
Time Frame
Baseline, Month 1, Month 2, Month 3
Secondary Outcome Measure Information:
Title
Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses
Description
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.
Time Frame
Baseline, Month 1, Month 2, Month 3
Title
Dry Eye Ocular Surface Disease Index (OSDI) Questionnaire Responses
Description
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.
Time Frame
Baseline, Month 1, Month 2, Month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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;
Other protocol-defined inclusion criteria may apply.
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;
Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danyel C. Carr, MS, CCRA
Organizational Affiliation
Alcon Research
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Donald R Korb, O.D.
Organizational Affiliation
Korb and Associates
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
SYSTANE® Family - Meibomian Deficiency
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