1 Week Crossover Study Between Two Soft Contact Lenses

1 Week Crossover Dispensing Study: Buttermere Versus MiSight 1 Day Soft Contact Lenses

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

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Test Lenses (stenfilcon A); Device: Control Lenses (omafilcon A)

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Bloomington, Indiana, United States, 47405
      • Clinical Optics Research Lab (CORL)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Test Lenses (stenfilcon A); Daily disposable, soft contact lenses worn for one week.; Device: Control Lenses (omafilcon A); Daily disposable, soft contact lenses worn for one week.
Experimental: 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.	Device: Test Lenses (stenfilcon A); Daily disposable, soft contact lenses worn for one week.; Device: Control Lenses (omafilcon A); Daily disposable, soft contact lenses worn for one week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Vision Quality	Subjective vision quality on 0-100 Visual Analog Scale (where, 0=very poor and 100=very good)	At the end of one week wear

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Pete S Kollbaum, OD, PhD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2024
• Primary Completion (Actual): July 26, 2024
• Study Completion (Actual): July 26, 2024

Study Registration Dates

• First Submitted: September 23, 2024
• First Submitted That Met QC Criteria: September 23, 2024
• First Posted (Actual): September 25, 2024

Study Record Updates

• Last Update Posted (Estimated): October 15, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CV-23-59

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes