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

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

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

Study Overview

• Status: Completed
• Conditions: Visual Acuity; Contact Lens Comfort
• Intervention / Treatment: Device: Menicon Modified Lens 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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada
      • University of Waterloo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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; -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Menicon DSRB Redesign; Menicon DSRB Modified Lens Design is a single use contact lens with revised thickness specifications worn for 6 hours or more.	Device: Menicon Modified Lens Design; Randomized in a daily wear, single day (6 hours or more) evaluation
Active Comparator: Menicon DSRB Original Design; Menicon DSRB Initial Lens Design is a single use contact lens with the original thickness specifications worn for 6 hours or more.	Device: Menicon Modified Lens Design; Randomized in a daily wear, single day (6 hours or more) evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Menicon Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2018
• Primary Completion (Actual): March 29, 2018
• Study Completion (Actual): March 29, 2018

Study Registration Dates

• First Submitted: February 20, 2018
• First Submitted That Met QC Criteria: March 2, 2018
• First Posted (Actual): March 6, 2018

Study Record Updates

• Last Update Posted (Actual): October 5, 2018
• Last Update Submitted That Met QC Criteria: October 4, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: P/626/17/M

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No