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N/A N=30 Randomized Double-blind Treatment

Comparing a Monthly Replacement Lens Versus a Daily Disposable Lens

Myopia

Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Lens Handling at Insertion — 83; 93 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Control Lens (Device); Test Lens (Device)
Age
Pediatric, Adult · 17+ yrs
Sex
All
Sponsor
CooperVision, Inc.
Primary completion
Nov 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Lens Handling at Insertion
83; 93

Summary

The purpose of this study was to compare subjective ratings of lens handling at insertion for a monthly replacement lens versus a daily disposable lens in habitual soft lens wearers.

Eligibility Criteria

Inclusion Criteria

  • Were 17 to 40 years of age and have full legal capacity to volunteer;
  • Had read and signed an information consent letter;
  • Were willing and able to follow instructions and maintain the appointment schedule;
  • Were habitual daily wearers of spherical single vision soft contact lenses to correct for distance vision in each eye
  • Were correctable to a visual acuity of 20/20 or better (in each eye) with sphero-cylindrical subjective refraction;
  • Had an astigmatism of ≤ 0.75DC in subjective refraction;
  • Could be fit with the study contact lenses with a power between -1.00 and -6.00DS; this translates to best corrected vision sphere refraction that vertexes to a CL power between -1.00 and -6.00 (inclusive) at screening visit.
  • Demonstrated an acceptable fit with the study lenses.

Exclusion Criteria

  • Had taken part in another clinical research study within the last 14 days;
  • Were currently habitual wearers of toric, multifocal or monovision lenses.
  • Had worn any rigid contact lenses in the past 6 months
  • Were an extended lens wearer (i.e., sleeping with their lenses)
  • Had a difference of ≥1.5 D in best vision sphere subjective refraction between eyes;
  • Had amblyopia and/or distance strabismus/binocular vision problem;
  • Had any known active ocular disease, allergies and/or infection;
  • Had a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  • Were using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
  • Had a known sensitivity to the diagnostic pharmaceuticals to be used in the study;
  • Had undergone refractive error surgery or intraocular surgery;
  • Were a member of CORE directly involved in the study.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06046209). 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.

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