Systane Balance - Inflammatory Markers
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/30/2013 |
Start Date: | March 2013 |
End Date: | December 2013 |
Contact: | Alcon Call Center |
Phone: | 1-888-241-7629 |
Study to Evaluate the Efficacy of Systane Balance in Reducing Symptoms and Inflammatory Biomarker Expression of HLA-DR and Tear Film Cytokines in Dry Eye Subjects With Lipid Deficiency
The purpose of this study is to evaluate the ability of Systane Balance dosed four times a
day for 30 days to improve comfort over baseline compared to Systane gel.
Inclusion Criteria:
- Read, sign, and date the Informed Consent Document;
- Willing and able to follow instructions and maintain the appointment schedule;
- Must not have used any topical ocular drops for approximately 24 hours prior to Visit
1;
- Meet the protocol-specified dry eye criteria at Screening Visit (Visit 1);
- Willing to use study drugs 4 times per day in both eyes;
- Willing to discontinue use of other artificial tear products and other eyedrops;
- Intraocular pressure less than or equal to 22 mmHg in both eyes;
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- History or evidence of ocular or intraocular surgery or serious 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;
- Use of any concomitant topical ocular medications during the study period;
- Currently using Restasis and unwilling to discontinue its use 1 month prior to
screening and for the entire 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;
- Uncontrolled ocular conditions such as uveitis, glaucoma or any other ocular
condition 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;
- Pregnant or lactating women;
- Monocular or legally blind;
- Other protocol-defined exclusion criteria may apply.
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