Systane Family - Meibomian Deficiency
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/3/2013 |
Start Date: | February 2013 |
End Date: | September 2013 |
Contact: | Alcon Call Center |
Phone: | 1-888-451-3937 |
Systane Family Efficacy in Meibomian Gland Functionality for Lipid Deficient Evaporative Dry Eye Subjects
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.
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 6/60 (20/20 Snellen, 1.0 logMAR) 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 six 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
one 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.
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