1 Week Crossover Study Between Two Soft Contact Lenses

NCT06611410 | Completed Results FDA Device

• 1 other identifier: CV-23-59
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• High Contrast, Binocular, Distance Visual Acuity (logMAR)

  High contrast, binocular, distance visual acuity (logMAR) will be measured at 1-week visit.

  At the end of one week wear

Secondary Outcomes (1)

• Subjective Vision Quality

  At the end of one week wear

Study Arms (2)

Test Lenses, Then Control Lenses

EXPERIMENTAL

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.

Device: Test Lenses (stenfilcon A); Device: Control Lenses (omafilcon A)

Control Lenses, Then Test Lenses

EXPERIMENTAL

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.

Device: Test Lenses (stenfilcon A); Device: Control Lenses (omafilcon A)

Interventions

Test Lenses (stenfilcon A) DEVICE

Daily disposable, soft contact lenses worn for one week.

Control Lenses, Then Test Lenses; Test Lenses, Then Control Lenses

Control Lenses (omafilcon A) DEVICE

Daily disposable, soft contact lenses worn for one week.

Control Lenses, Then Test Lenses; Test Lenses, Then Control Lenses

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

Clinical Optics Research Lab (CORL)

Bloomington, Indiana, 47405, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Lee Hall
• Organization: CooperVision

LHall@coopervision.com

+19256604365

Study Officials

• Pete S Kollbaum, OD, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• 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 23, 2024
• First Posted: September 25, 2024
• Study Start: June 5, 2024
• Primary Completion: July 26, 2024
• Study Completion: July 26, 2024
• Last Updated: October 15, 2025
• Results First Posted: October 15, 2025

Record last verified: 2025-08

Locations

US (1)