Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Period 1
FID 114657 or SootheXP
FID114657
artificial tears
SootheXP Emollient (Lubricant) Eye Drops
artificial tears
Period 2
FID 114657 or SootheXP
FID114657
artificial tears
SootheXP Emollient (Lubricant) Eye Drops
artificial tears
Interventions
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FID114657
artificial tears
SootheXP Emollient (Lubricant) Eye Drops
artificial tears
Eligibility Criteria
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Inclusion Criteria
2. Patients (minimum age 18) with dry eye. Criteria for the diagnosis must include the following characteristics at Visit 1 (Screening): Patients' self-assessment of dry eye status (answer of at least Some of the time to the question, "How often have your eyes felt dry enough to want to use eye drops?");TFBUT \<5 seconds in at least one eye; \> Grade 1 for Meibomian Gland Expression in both eyes; Evidence of missing meibomian glands in both eyes.
3. Able and willing to follow study instructions.
4. Patients must have best-corrected visual acuity of 0.6 logMAR or better in each eye as assessed using an ETDRS chart at Visit 1.
5. Patients must not have used any topical ocular drops for approximately 24 hours prior to Visit 1.
Exclusion Criteria
2. History or evidence of serious ocular trauma in either eye within the past six months.
3. Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs).
4. History of intolerance or hypersensitivity to any component of the study medications.
5. 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.
6. Use of any concomitant topical ocular medications during the study period.
7. Patients using systemic medications that may contribute to dry eye (e.g. cold and allergy medications, tricyclic antidepressants, hormone replacement therapies) may not be enrolled in the study unless they have been on a stable dosing regimen for a minimum of 30 days prior to Visit 1. In addition, the dosing regimen must remain stable throughout the study.
8. Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude safe administration of the test article.
9. Individuals unwilling to discontinue contact lens wear during the study period. Contact lens wear must have been discontinued at least one week prior to Visit 1.
10. Enrollment of investigator's office staff, relatives, or members of their respective households; or enrollment of more than one member of the same household.
11. Participation in an investigational drug or device study within 30 days of entering this study.
18 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Countries
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References
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Benelli U. Systane lubricant eye drops in the management of ocular dryness. Clin Ophthalmol. 2011;5:783-90. doi: 10.2147/OPTH.S13773. Epub 2011 Jun 10.
Other Identifiers
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C-09-030
Identifier Type: -
Identifier Source: org_study_id