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

Not Applicable

Completed

• Conditions: Contact Lens Comfort; Visual Acuity
• Interventions: Device: Menicon Modified Lens Design

• Registration Number: NCT03454542
• Lead Sponsor: Menicon Co., Ltd.

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.

Study Timeline

• Study Start: 2018-02-14
• Study First Submitted: 2018-02-20
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-02
• Study First Posted: 2018-03-06
• Primary Completion: 2018-03-29
• Study Completion: 2018-03-29
• Last Update Submitted: 2018-10-04
• Last Update Posted: 2018-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Menicon DSRB Redesign	Menicon Modified Lens Design	Menicon DSRB Modified Lens Design is a single use contact lens with revised thickness specifications worn for 6 hours or more.
Menicon DSRB Original Design	Menicon Modified Lens Design	Menicon DSRB Initial Lens Design is a single use contact lens with the original thickness specifications worn for 6 hours or more.

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Waterloo; 🇨🇦 Waterloo, Ontario, Canada