Clinical trial NCT03454542: Assessment of Comfort & Ocular Surface Parameters w Novel Designs of Daily Disposable Silicone Hydrogel Contact Lenses
Official title: Assessment of Comfort and Ocular Surface Parameters With Novel Designs of Daily Disposable Silicone Hydrogel Contact Lenses (BASS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Contact Lens Comfort
Lead sponsor: Menicon Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-03-06
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This will be a double-masked, cross-over, bilateral wear study design with five (5) study visits across three (3) study visit days. Participants will be dispensed and wear both the initial and modified lens design for a total of six (6) hours each on two (2) separate visit days, with the order of lens wear being randomized; participants will be allowed to leave the CCLR on their lens wearing days between dispense and follow-up visit.
Primary purpose: TREATMENT

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 compared to the initial design

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 modification of lens thickness in the optical zone results in increased comfort and reduced visual acuity fluctuations in Caucasian eyes.

Eligibility criteria: Inclusion Criteria:

1. Is at least 18 years of age and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Is willing and able to follow instructions and maintain the appointment schedule;
4. Is of Caucasian heritage;
5. Habitually wears soft spherical daily disposable contact lenses with a power between

   -0.50 to -2.75D (inclusive);
6. Demonstrates an acceptable fit with both study CL designs (initial \& modified);
7. Is correctable to a visual acuity of 0.20 LogMAR (approximately 20/30) or better (in each eye) with both study CL designs;
8. Has a manifest cylindrical spectacle refraction that does not exceed -1.00DC in either eye;
9. Should own a wearable pair of spectacles. -

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study;
2. Has any known active\* ocular disease and/or infection;
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by self-report);
7. Is aphakic;
8. Has undergone refractive error surgery; -

Primary outcomes:
measure: Participant's subjective rating of comfort, Questionnaire
timeFrame: 2 Days
measure: Participant's subjective rating of vision, Questionnaire
timeFrame: 2 Days
measure: Participant's subjective rating of lens handling, Questionnaire
timeFrame: 2 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: University of Waterloo
state: Ontario
Study officials:
References: