Status:
COMPLETED
Assessment of Comfort & Ocular Surface Parameters w Novel Designs of Daily Disposable Silicone Hydrogel Contact Lenses
Lead Sponsor:
Menicon Co., Ltd.
Conditions:
Visual Acuity
Contact Lens Comfort
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A comparison of two lens designs manufactured in the same material. The hypothesis is the subjectively rated performance of comfort, vision and lens handling will be better with the modified design co...
Detailed Description
The objectives of the study are 1. to identify possible reasons for the different comfort and vision experience in Japanese CL wearers compared to Caucasian CL wearers and 2. to assess whether the mo...
Eligibility Criteria
Inclusion
- Is at least 18 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Is of Caucasian heritage;
- Habitually wears soft spherical daily disposable contact lenses with a power between
- 50 to -2.75D (inclusive);
- Demonstrates an acceptable fit with both study CL designs (initial \& modified);
- Is correctable to a visual acuity of 0.20 LogMAR (approximately 20/30) or better (in each eye) with both study CL designs;
- Has a manifest cylindrical spectacle refraction that does not exceed -1.00DC in either eye;
- Should own a wearable pair of spectacles. -
Exclusion
- Is participating in any concurrent clinical or research study;
- Has any known active\* ocular disease and/or infection;
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- Is pregnant, lactating or planning a pregnancy at the time of enrolment (by self-report);
- Is aphakic;
- Has undergone refractive error surgery; -
Key Trial Info
Start Date :
February 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 29 2018
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03454542
Start Date
February 14 2018
End Date
March 29 2018
Last Update
October 5 2018
Active Locations (1)
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1
University of Waterloo
Waterloo, Ontario, Canada