Status:
COMPLETED
Residence Time Evaluation of Marketed OTC Ophthalmic Products
Lead Sponsor:
Alcon Research
Conditions:
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this study is to measure ocular surface residence time (in minutes) of two marketed OTC ophthalmic products in dry eye patients.
Eligibility Criteria
Inclusion
- Informed consent and HIPAA read, signed and dated before conducting any procedures.
- Adult volunteers diagnosed with mild to moderate dry eye. Criteria for diagnosis must include 2 of the 3 following characteristics: composite symptom score \> or = to 5 on modified Schein questionnaire; NaFl TFBUT \< or = to 7 seconds in either eye; or NaFl corneal staining sum score \> or = to 3 (using 0-15 point grading system).
- Able and willing to follow study instructions. 4) Best-corrected V.A. of 0.6 logMAR or better OU.
Exclusion
- History or evidence of ocular or intraocular surgery in either eye w/i the past 6 months.
- History or evidence of serious ocular trauma in either eye w/i the past 6 months.
- History of intolerance or hypersensitivity to any component of the study medications.
- History or evidence of epithelial herpes simplex keratitis, vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva and/or eyelids, mycobacterial infection of the eye, and/or fungal disease of the eye.
- Use of concomitant topical ocular medications during the study period.
- Patients using systemic medications that may contribute to dry eye may not be enrolled unless they have been on a stable dosing regimen for a minimum of 30 days prior to Visit 1, and the dosing regimen must remain stable throughout the study period.
- Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude the safe admininstration of the test article.
- Individuals unwilling to d/c contact lens wear during the study period. CL wear must have been d/c at least one week prior to Visit 1.
- Participation in an investigational drug or device study w/i 30 days of entering this study.
- Additionally, any subject may be declared ineligible for a valid medical reason.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00804791
Start Date
November 1 2008
Last Update
February 2 2012
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