Assessment of Comfort & Ocular Surface Parameters w Novel Designs of Daily Disposable Silicone Hydrogel Contact Lenses

Visual Acuity Clinical Trial

— BASS  

Official title:

Assessment of Comfort and Ocular Surface Parameters With Novel Designs of Daily Disposable Silicone Hydrogel Contact Lenses (BASS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03454542
• Other study ID #: P/626/17/M
• Status: Completed
• Phase: N/A
• Start date: February 14, 2018
• Est. completion date: March 29, 2018

Study information

• Verified date: March 2018
• Source: Menicon Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 29, 2018
• Est. primary completion date: March 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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; -

Related Conditions & MeSH terms

• Contact Lens Comfort
• Visual Acuity

Intervention

Device:
• Menicon Modified Lens Design
Randomized in a daily wear, single day (6 hours or more) evaluation

Locations

Country	Name	City	State
Canada	University of Waterloo	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Menicon Co., Ltd.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant's subjective rating of comfort, Questionnaire	Participants rate their eye comfort by subjective questionnaire (non-annotated scale, 0-100, 0=painful, 100=can't feel the lenses)	2 Days
Primary	Participant's subjective rating of vision, Questionnaire	Participants rate their vision by subjective questionnaire (non-annotated scale, 0-100, 0=not at all sharp/clear, 100=sharp/clear	2 Days
Primary	Participant's subjective rating of lens handling, Questionnaire	Participants rate their ability to handle the contact lens by subjective questionnaire (non-annotated scale, 0-100, 0=very difficult, 100=very easy	2 Days