This study compares contact lens comfortable wear duration, and signs and symptoms of contact lens discomfort, test versus control.
The clinical hypothesis is that CLM2 topical gel applied dermally on the forehead twice daily will be more effective than placebo (a) in reducing or eliminating ocular discomfort associated with contact lens wear, (b) prolong hours of comfortable wear, (c) prolong total hours of contact lens wear, (d) improve ease of insertion and removal of contact lens, and ( c) reduces friction between cornea/lens and lens/eyelid, without use of artificial eye drops or gels. One mechanism supporting this hypothesis is preliminary evidence of increased meibum secretion following CLM2 topical gel application.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Active topical gel for forehead dermal application
Placebo topical gel for forehead dermal application
UC Berkeley Clinical Research Center
Berkeley, California, United States
Hours of continuous comfortable contact lens wear
Change in total hours per day
Time frame: 21 days
Contact Lens Questionnaire-8 (CLDEQ-8)
Change in total score (0-37 worst)
Time frame: 21 days
Berkeley Dry Eye Flow Chart
Change in grade (1-5 worst)
Time frame: 21 days
Fluorescein corneal staining
Change in score (0-3 worst)
Time frame: 21 days
Eye discomfort from CLDEQ-8, frequency
Change in score (0-4 worst)
Time frame: 21 days
Eye discomfort from CLDEQ-8, intensity
Change in score (0-5 worst)
Time frame: 21 days
Glia contact lens symptoms questionnaire
Change in total score (0-64)
Time frame: 21 days
Fluorescein conjunctival staining
Change in conjunctival staining (0-3 worst)
Time frame: 21 days
Tear film examination by TearScan
Change in total score (0-3 best)
Time frame: 60-80 minutes
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Tear film examination by TearScan
Change in total score (0-3 best)
Time frame: 21 days
Tear film breakup time
Change in score (seconds)
Time frame: 60-80 minutes
Tear film breakup time
Change in score (seconds)
Time frame: 21 days
Tear meniscus height
Change in height (mm)
Time frame: 60-80 minutes
Tear meniscus height
Change in height (mm)
Time frame: 21 days
Visual acuity
Change in visual acuity
Time frame: 21 days
Tear osmolarity
Change in tear osmolarity (mOsm/L)
Time frame: 21 days
Schirmer test
Change in wetting length (mm)
Time frame: 21 days