1 Week Crossover Study Between Two Soft Contact Lenses

NCT ID: NCT06611410

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-05
• Study Completion Date: 2024-07-26

Brief Summary

The objective of this investigation is to compare the visual clinical performance of two daily disposable soft contact lenses.

Detailed Description

This is a prospective, multiple day, double (investigator and subject) masked, randomized, bilateral crossover study comparing a Test lens against an appropriate Control lens. Main aim is to compare visual acuity and subjective vision ratings of vision quality between two lenses in habitual soft lens wearers.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Test Lenses, Then Control Lenses

Participants will wear the Test Lenses in both eyes for one week and then cross over to the Control Lenses in both eyes for one week.

Group Type: EXPERIMENTAL

Test Lenses (stenfilcon A)

Intervention Type: DEVICE

Daily disposable, soft contact lenses worn for one week.

Control Lenses (omafilcon A)

Intervention Type: DEVICE

Daily disposable, soft contact lenses worn for one week.

Control Lenses, Then Test Lenses

Participants will wear the Control Lenses in both eyes for one week and then cross over to the Test Lenses in both eyes for one week.

Group Type: EXPERIMENTAL

Test Lenses (stenfilcon A)

Intervention Type: DEVICE

Daily disposable, soft contact lenses worn for one week.

Control Lenses (omafilcon A)

Intervention Type: DEVICE

Daily disposable, soft contact lenses worn for one week.

Interventions

Test Lenses (stenfilcon A)

Daily disposable, soft contact lenses worn for one week.

Intervention Type: DEVICE

Control Lenses (omafilcon A)

Daily disposable, soft contact lenses worn for one week.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Are 8 to 18 years of age (inclusively)
• Have read, signed and dated:

• Age 18 - The Participant Informed Consent Form (participant only)
• Age 12-17 - The Parental Permission Form (participant and parent)
• Age 8-11 - The Parental Permission Form (parent) and Assent form (participant)
• Are willing and able to follow instructions and maintain the appointment schedule.
• Are habitual daily wearers of spherical single vision soft contact lenses to correct for distance vision in each eye, including myopia control soft contact lenses as below-
• Currently wears spherical soft contact lenses or myopia control soft contact lenses.
• Have a pair of wearable back-up spectacles.
• Are willing and able to wear contact lenses for at least 10 hours a day, 6 days a week while in the study.
• Are myopic with subjective refraction: -0.75D to -7.00D spherical, with an astigmatism ≤ -0.75D in each eye with maximum spherical equivalent anisometropia of 1.00D
• Are correctable to a visual acuity of +0.10 logMAR or better (in each eye) with sphero-cylindrical subjective refraction.
• Have clear corneas with no corneal scars or any active ocular disease.
• Can be fit with the study contact lenses with a power between -0.75 and -7.00 DS; this translates to best corrected vision sphere refraction that vertexes to a CL power between -0.75 and -7.00 (inclusive) at screening visit.
• Demonstrate an acceptable fit with the study contact lenses.
• Demonstrate that they can safely and independently insert and remove contact lenses at the screening/fitting visit.

Exclusion Criteria

• Have taken part in another clinical research study within the last 14 days.
• Are currently habitual wearers of toric contact lenses.
• Have worn any rigid contact lenses or ortho-keratology contact lenses in the past 30 days.
• Are an extended contact lens wearer (i.e., sleeping with their contact lenses).
• Are on ongoing atropine treatment for myopia control.
• Have a difference of > 1.0 D in best vision sphere subjective refraction between eyes.
• Have amblyopia and/or strabismus/binocular vision problem.
• Have any known active ocular disease, allergies and/or infection.
• Have a systemic condition that in the opinion of the investigator may affect a study outcome variable.
• Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable.
• Have a known sensitivity to the diagnostic pharmaceuticals to be used in the study.
• Have undergone refractive error surgery or intraocular surgery.
• Are a member of CORL directly involved in the study.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pete S Kollbaum, OD, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Clinical Optics Research Lab (CORL)

Bloomington, Indiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CV-23-59

Identifier Type: -

Identifier Source: org_study_id