Comparing a Monthly Replacement Lens Versus a Daily Disposable Lens

NCT06046209 | Completed Results FDA Device

• 1 other identifier: CV-23-36
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to compare subjective ratings of lens handling at insertion for a monthly replacement lens versus a daily disposable lens in habitual soft lens wearers.

Conditions

Myopia

Keywords

Refractive Errors; Eye Diseases

Outcome Measures

Primary Outcomes (1)

• Lens Handling at Insertion

  Participants completed subjective ratings of the ease of application of the study lenses to eye immediately after lens application on a 0-100 integer scale, where 100=very easy and 0=very difficult.

  Immediately after lens application

Study Arms (2)

Control Lens, then Test Lens

EXPERIMENTAL

Participants wore the Control Lens for 90 minutes, then the Test Lens for 90 minutes.

Device: Control Lens; Device: Test Lens

Test Lens, then Control Lens

EXPERIMENTAL

Participants wore the Test Lens for 90 minutes, then the Control Lens for 90 minutes.

Device: Control Lens; Device: Test Lens

Interventions

Control Lens DEVICE

Daily disposable contact lens for 90 minutes

Control Lens, then Test Lens; Test Lens, then Control Lens

Test Lens DEVICE

Monthly replacement contact lens for 90 minutes

Control Lens, then Test Lens; Test Lens, then Control Lens

Eligibility Criteria

• Age: 17 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Were 17 to 40 years of age and have full legal capacity to volunteer;
• Had read and signed an information consent letter;
• Were willing and able to follow instructions and maintain the appointment schedule;
• Were habitual daily wearers of spherical single vision soft contact lenses to correct for distance vision in each eye
• Were correctable to a visual acuity of 20/20 or better (in each eye) with sphero-cylindrical subjective refraction;
• Had an astigmatism of ≤ 0.75DC in subjective refraction;
• Could be fit with the study contact lenses with a power between -1.00 and -6.00DS; this translates to best corrected vision sphere refraction that vertexes to a CL power between -1.00 and -6.00 (inclusive) at screening visit.
• Demonstrated an acceptable fit with the study lenses.

You may not qualify if:

• Had taken part in another clinical research study within the last 14 days;
• Were currently habitual wearers of toric, multifocal or monovision lenses.
• Had worn any rigid contact lenses in the past 6 months
• Were an extended lens wearer (i.e., sleeping with their lenses)
• Had a difference of ≥1.5 D in best vision sphere subjective refraction between eyes;
• Had amblyopia and/or distance strabismus/binocular vision problem;
• Had any known active ocular disease, allergies and/or infection;
• Had a systemic condition that in the opinion of the investigator may affect a study outcome variable;
• Were using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
• Had a known sensitivity to the diagnostic pharmaceuticals to be used in the study;
• Had undergone refractive error surgery or intraocular surgery;
• Were a member of CORE directly involved in the study.

Sponsors & Collaborators

• CooperVision, Inc.: lead
• Centre for Ocular Research & Education, Canada: collaborator

Study Sites (1)

University of Waterloo School of Optometry & Vision Science

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Myopia; Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Lee Hall
• Organization: CooperVision, Inc.

lhall@coopervision.com

+19252516684

Study Officials

• Lyndon Jones, PhD FCOptom

  Centre for Ocular Research and Education (CORE)

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

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: September 14, 2023
• First Posted: September 21, 2023
• Study Start: September 28, 2023
• Primary Completion: November 22, 2023
• Study Completion: November 22, 2023
• Last Updated: December 12, 2024
• Results First Posted: December 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)