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N/A Completed N=48 Randomized Double-blind Treatment

Performance Evaluation of Two Daily Disposable Toric Lens Designs in Habitual Soft Contact Lens Wearers

Astigmatism
Source: ClinicalTrials.gov NCT04831515 ↗
Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcomePrimary: Overall Ease of Lens Handling — 9.0; 8.8 units on a scale

Summary

The objective of the study is to compare the clinical performance of two different daily disposable, SiHy toric contact lens types, Lens A and Lens B, in existing soft lens wearers when worn for one week each.

Outcome Measures

OutcomeResultp-value
PRIMARY
Overall Ease of Lens Handling
9.0; 8.8
SECONDARY
Visual Acuity
-0.06; -0.05

Eligibility Criteria

Inclusion Criteria

  • Is at least 18 years of age 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 12 hours a day, 7 days a week;
  • Is willing and able to follow instructions and maintain the appointment schedule;
  • Habitually wears toric soft contact lenses binocularly, of any replacement frequency, for the past 3 months minimum;
  • Has refractive astigmatism at least -0.75DC in each eye, maximum -2.25DC;
  • Has refractive cylinder axis either between 155 to 25 or between 65 and 115 degrees;
  • Is myopic and requires a spectacle spherical component of -1.00D to -6.50D inclusively;
  • Can be fit and achieve binocular distance vision of at least 20/30 Snellen with the available lens parameters

Exclusion Criteria

  • Is participating in any concurrent clinical or research study;
  • Habitually wears one of the study contact lenses;
  • 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 (NCT04831515). 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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