Status:
COMPLETED
1 Week Crossover Study Between Two Soft Contact Lenses
Lead Sponsor:
CooperVision, Inc.
Conditions:
Myopia
Eligibility:
All Genders
8-18 years
Phase:
NA
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 v...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 26 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06611410
Start Date
June 5 2024
End Date
July 26 2024
Last Update
October 15 2025
Active Locations (1)
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1
Clinical Optics Research Lab (CORL)
Bloomington, Indiana, United States, 47405