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N/A N=49 Randomized Single-blind Treatment

Performance Evaluation of Two Silicone Hydrogel Toric Lens Designs in Habitual Soft Contact Lens Wearers

Astigmatism

Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Lens Handling on Removal — 89; 91 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Lens A (comfilcon A toric lens) (Device); Lens B (lehfilcon A toric lens) (Device)
Age
Adult · 18+ yrs
Sex
All
Sponsor
CooperVision International Limited (CVIL)
Primary completion
Dec 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Lens Handling on Removal
89; 91
SECONDARY
Distance Visual Acuity
-0.06; -0.06

Summary

The objective of the study was to compare the clinical performance of two monthly toric silicone hydrogel contact lenses in habitual wearers, when worn for 1-month each.

Eligibility Criteria

Inclusion Criteria

  • Is between 18 and 39 years of age (inclusive) and has full legal capacity to volunteer;
  • Has read and signed an information consent letter;
  • Self-reports having a full eye examination in the previous two years;
  • Anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week;
  • Is willing and able to follow instructions and maintain the appointment schedule;
  • Habitually wears of toric soft contact lenses binocularly.
  • No more than 1/3 of the participants should be wearing daily disposable soft toric lenses;
  • the remaining 2/3+ of the participants must be planned frequent replacement soft toric lens wearers as follows:
  • i. TOTAL30 for Astigmatism: maximum of 3 (∼10%) (no target percentage)
  • ii. Biofinity toric: maximum of 13 (∼40%) (PLUS a target of minimum 10 (∼30%))
  • iii. Air Optix for Astigmatism (inclusive of +Hydraglyde): maximum of 10 (∼30%) (PLUS a target of minimum 7 (∼20%))
  • iv. ULTRA for Astigmatism: maximum of 5 (∼15%) (no target percentage)
  • v. Acuvue Vita for Astigmatism: maximum of 3 (∼10%) (no target percentage)
  • vi. Acuvue Oasys for Astigmatism: maximum of 10 (∼30%) (no target percentage)
  • vii. Other brands of frequent replacement: maximum of 7 (∼20%) (no target percentage)
  • Has refractive astigmatism of at least -0.75DC but no more than -2.75DC in each eye that is correctable with a soft toric lens with a cylinder power of no greater than -2.25DC;
  • Is ammetropic and requires a spectacle spherical component of +8.00 to -10.00D inclusively;
  • Can be fit and achieve binocular distance vision of at least 20/32 Snellen with the available lens parameters

Exclusion Criteria

  • Is participating in any concurrent clinical or research study;
  • Has any known active ocular disease and/or infection that contraindicates contact lens wear;
  • Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  • Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
  • Has known sensitivity to the diagnostic sodium fluorescein used in the study;
  • Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
  • Has undergone refractive error surgery or intraocular surgery.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05933772). 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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