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N/A Completed N=9 Randomized Double-blind Treatment

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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