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N/A N=26 Randomized Double-blind Treatment

To Evaluate The Performance Of Two Monthly Replacement Silicone Hydrogel Contact Lenses After 1-month Of Wear

Myopia

Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Lens Handling on Lens Removal — 8.4; 8.9 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Lens A (lehfilcon A lens) (Device); Lens B (comfilcon A lens) (Device)
Age
Pediatric, Adult, Older Adult · 17+ yrs
Sex
All
Sponsor
CooperVision, Inc.
Primary completion
Sep 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Lens Handling on Lens Removal
8.4; 8.9

Summary

To evaluate the performance of two monthly replacement silicone hydrogel contact lenses in habitual FRP CL wearers when worn for 1-month.

Eligibility Criteria

Inclusion Criteria

  • Is at least 17 years of age and has full legal capacity to volunteer;
  • Self-reports having had a full eye examination within the previous 2 years;
  • Has read and signed an information consent letter;
  • Is willing and able to follow instructions and maintain the appointment schedule;
  • Is a habitual wearer of frequent replacement contact lenses;
  • Anticipates no difficulty wearing the contact lenses for 6 days/week and 8 hours/day during the study;
  • Has refractive astigmatism no higher than -0.75DC in each eye;
  • Can be successfully fit with both study lens types;
  • Achieves at least 0.4 logMAR VA monocularly and at least 0.2 logMAR VA binocularly with each study lens type.

Exclusion Criteria

  • Is participating in any concurrent clinical research study;
  • Has any known active ocular disease and/or infection;
  • Has an unstable systemic condition that in the opinion of the investigator may affect vision or contact lens comfort across the 2-month study duration;
  • Is using any systemic or topical medications in an irregular routine that in the opinion of the investigator may affect vision or contact lens comfort across the 2-month study duration;
  • Has known sensitivity to the diagnostic sodium fluorescein to be used in the study;
  • Is an employee of the Centre for Ocular Research & Education.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05333965). 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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