Comparing The Performance Of Two Different Daily Disposable Lenses (MIKI)

NCT04492397 | Completed Results FDA Device

• 1 other identifier: EX-MKTG-114
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to evaluate and compare the performance of study test lens to study control lens, when worn on a daily disposable modality over a period of approximately one week each

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Overall Lens Fit Acceptance

  Overall fit acceptance (0-4, 0.50 steps) (0 - lens should not be worn at all,1 - Borderline but unacceptable, 2 - Minimally acceptable, 3 - Not perfect but OK to dispense, 4 - Perfect)

  1 week

Secondary Outcomes (6)

• Lens Centration

  Baseline

• Lens Centration

  1 week

• Post-blink Movement

  Baseline

• Post-blink Movement

  1 week

• Push-up Tightness

  Baseline

Study Arms (2)

Test Contact lens

EXPERIMENTAL

Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week.

Device: Test Contact Lens; Device: Control Contact Lens

Control Contact Lens

ACTIVE COMPARATOR

Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week.

Device: Test Contact Lens; Device: Control Contact Lens

Interventions

Test Contact Lens DEVICE

Subjects will be randomized to wear test lenses.

Also known as: stenfilcon A

Control Contact Lens; Test Contact lens

Control Contact Lens DEVICE

Subjects will be randomized to wear control lenses.

Also known as: verofilcon A

Control Contact Lens; Test Contact lens

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Is at least 17 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;
• Habitually wears soft contact lenses in daily wear, for minimum of 6-months;
• Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses;
• Has an astigmatism of ≤ 1.00 D in subjective refraction;
• Can be fit with study contact lenses with a power between -2.00 and -5.00 DS;
• Demonstrates an acceptable fit with the study lenses;
• Habitually wears single vision soft contact lenses for at least 8 hours per day, 5 days a week, and is willing to wear contact lenses for at least 12 hours a day in the study.

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 because the associated hormonal changes cause changes in the tear layer which impact contact lens comfort. Verbal confirmation at the screening visit is sufficient;
• Is aphakic;
• Has undergone refractive error surgery;
• Is an employee of the Centre for Ocular Research \& Education;
• Has participated in the BOXER (i.e. EX-MKTG-107, phases 1 or 2) or BASSET (EXMKTG-113) Study;
• Has participated in any clinical trials within a week prior to the study.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Jose A. Vega, O.D., MSc, FAAO
• Organization: Coopervision

JVega2@coopervision.com

9256213761

Study Officials

• Lyndon Jones, PhD FCOptom

  University of Waterloo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: July 30, 2020
• Study Start: September 30, 2020
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: June 23, 2021
• Results First Posted: June 21, 2021

Record last verified: 2021-06

Locations

CA (1)