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

NCT03454542 | Completed

• 1 other identifier: P/626/17/M
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Visual Acuity; Contact Lens Comfort

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Menicon DSRB Redesign

EXPERIMENTAL

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

Menicon DSRB Original Design

ACTIVE COMPARATOR

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

Interventions

Menicon Modified Lens Design DEVICE

Randomized in a daily wear, single day (6 hours or more) evaluation

Menicon DSRB Original Design; Menicon DSRB Redesign

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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. -

You may not qualify if:

• 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; -

Sponsors & Collaborators

• Menicon Co., Ltd.: lead

Study Sites (1)

University of Waterloo

Waterloo, Ontario, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This will be a double-masked study, with both the study participants and study investigators being masked to the order of lens wear for the initial and modified DD lens design. Study lenses will be dispensed to the participants at V2 and V4 by unmasked research assistants from paper cups. Lenses and blister-pack solution will be directly transferred into the paper cups, and only the paper cups will be taken to the examination room where lenses are being dispensed.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: March 6, 2018
• Study Start: February 14, 2018
• Primary Completion: March 29, 2018
• Study Completion: March 29, 2018
• Last Updated: October 5, 2018

Record last verified: 2018-03

Locations

CA (1)