1 Week Crossover Dispensing Study Between Two Soft Contact Lenses

CooperVision, Inc.

Status: Completed

Conditions: Myopia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06170658

CV-23-58

Details and patient eligibility

About

The objective of this investigation is to compare the visual clinical performance of a silicone hydrogel daily disposable investigational contact lenses to a hydrogel daily disposable commercially available contact lenses.

Full description

This is a prospective, bilateral, double masked (participant and investigator), randomized, cross-over dispensing study with 1 week wearing period in each arm by comparing visual acuity and subjective vision quality.

Enrollment: 30 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Are 8 to 18 years of age inclusive and have full legal capacity to volunteer;
2. Have read and signed and dated the Parental Permission Form (for those aged 16 and younger); participant has read, signed and dated the study Information Consent Letter (if aged 17 or 18 years) or Assent (aged 16 and younger);
3. Are willing and able to follow instructions and maintain the appointment schedule;
4. Are habitual daily wearers of spherical single vision soft contact lenses to correct for distance vision in each eye;
5. Currently wears spherical soft contact lenses or myopia control soft lenses;
6. Have a pair of wearable back-up spectacles;
7. Are willing and able to wear contact lenses for at least 10 hours a day, 6 days a week while in the study;
8. 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
9. Are correctable to a visual acuity of +0.10 logMAR or better (in each eye) with sphero-cylindrical subjective refraction;
10. Have clear corneas with no corneal scars or any active ocular disease;
11. 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.
12. Demonstrate an acceptable fit with the study lenses.
13. Demonstrate that they can safely and independently insert and remove contact lenses at the screening/fitting visit;

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Test Lenses, Then Control Lenses

Experimental group

Description:

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.

Treatment:

Device: Test Lenses (stenfilcon A)

Device: Control Lenses (omafilcon A)

Control Lenses, Then Test Lenses

Experimental group

Description:

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.

Treatment:

Device: Test Lenses (stenfilcon A)

Device: Control Lenses (omafilcon A)