SYSTANE® Family - Meibomian Deficiency

Dry Eye Syndrome Clinical Trial

— M-12-077  

Official title:

SYSTANE® Family Efficacy in Meibomian Gland Functionality for Lipid Deficient Evaporative Dry Eye Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01733745
• Other study ID #: A00978
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: June 2013

Study information

• Verified date: September 2013
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Other:
• SYSTANE® Lid Wipes
Pre-moistened eyelid cleansing wipes for topical ocular external scrubbing of eyelids and eyelashes
• SYSTANE® BALANCE
Lubricant Eye Drops

Dietary Supplement:
• SYSTANE® Vitamins

Other:
• Microfiber towels (as warm compresses, with or without saline eye drops)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline, Month 1, Month 2, Month 3
Secondary	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.	Baseline, Month 1, Month 2, Month 3

External Links

•   Results from the Novartis Clinical Trial Results Website