N/A
Completed N=9
1 Week Crossover Study Between Two Soft Contact Lenses
Source: ClinicalTrials.gov NCT06611410 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcomePrimary: High Contrast, Binocular, Distance Visual Acuity (logMAR) — -0.15; -0.15 logMAR
Summary
The objective of this investigation is to compare the visual clinical performance of two daily disposable soft contact lenses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY High Contrast, Binocular, Distance Visual Acuity (logMAR) |
-0.15; -0.15 | — |
| SECONDARY Subjective Vision Quality |
94.12; 87.12 | — |
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.
Data sourced from ClinicalTrials.gov (NCT06611410). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.