Residence Time Evaluation of Marketed OTC Ophthalmic Products
Status
Completed
Conditions
Dry Eye
Treatments
Other: Systane Ultra Lubricant Eye Drops
Other: Unisol 4 Saline Solution
Details and patient eligibility
About
The objective of this study is to measure ocular surface residence time (in minutes) of two marketed OTC ophthalmic products in dry eye patients.
Enrollment
25 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- 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 criteria
- 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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Double Blind
25 participants in 2 patient groups
Systane
Active Comparator group
Description:
One drop dispensed into each eye
Treatment:
Other: Systane Ultra Lubricant Eye Drops
Unisol
Active Comparator group
Description:
One drop dispensed into each eye
Treatment:
Other: Unisol 4 Saline Solution
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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