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N/A N=33 Randomized Double-blind Treatment

Bilateral Dispensing Study of Fanfilcon A Toric Versus Enfilcon A Toric Lenses

Myopia · Hyperopia · Astigmatism

Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Comfort (Subjective Rating Scale) — 87; 88; 79; 76 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
fanfilcon A (Device); enfilcon A (Device)
Age
Pediatric, Adult, Older Adult · 17+ yrs
Sex
All
Sponsor
CooperVision, Inc.
Primary completion
Jan 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Comfort (Subjective Rating Scale)
87; 88; 79; 76
PRIMARY
Comfort Preference
12; 14; 10; 12; 9; 5

Summary

Bilateral dispensing clinical trial of fanfilcon A toric lens verses enfilcon A toric lens over two weeks.

Eligibility Criteria

Inclusion Criteria

  • Are at least 17 years of age for Canada and 18 years of age for the USA and have full legal capacity to volunteer;
  • Have read and signed an information consent letter;
  • Are willing and able to follow instructions and maintain the appointment schedule;
  • Are an adapted soft contact lens wearer;
  • Require spectacle lens powers in both eyes;
  • Sphere: between -0.50 to -6.00 diopters and
  • Astigmatism: between -1.25 to -2.00 and
  • Axis: 180 ± 20 degrees
  • Are willing to wear contact lens in both eyes;
  • Have manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye;
  • To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit including toric orientation as acceptable;

Exclusion Criteria

  • Are participating in any concurrent clinical or research study;
  • Have any known active* ocular disease 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 known sensitivity to the diagnostic pharmaceuticals to be used in the study;
  • Are pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
  • Are aphakic;
  • Have undergone refractive error surgery;
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02423109). 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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