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N/A N=23 Randomized Double-blind Treatment

A Bilateral Dispensing Clinical Trial of an Sapphire Lens Against Senofilcon A Toric for Astigmatism Lens

Astigmatism

Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Subjective Ratings for Comfort — 89; 80 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Sapphire contact lenses (Device); senofilcon A contact lenses (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
CooperVision, Inc.
Primary completion
Feb 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Subjective Ratings for Comfort
85; 72
PRIMARY
Subjective Ratings for Comfort
85; 72
PRIMARY
Subjective Ratings for Comfort Preference
68; 27; 5
PRIMARY
Subjective Ratings for Comfort Preference
68; 27; 5
PRIMARY
Subjective Assessment of Visual Quality
81; 73
PRIMARY
Subjective Assessment of Visual Quality
81; 73
PRIMARY
Subjective Assessment of Overall Satisfaction
87; 73
PRIMARY
Subjective Assessment of Overall Satisfaction
87; 73
PRIMARY
Subjective Overall Preference
73; 4; 23
PRIMARY
Subjective Overall Preference
73; 4; 23

Summary

This study was conducted to evaluate the clinical performance of an investigational silicone-hydrogel lens against Senofilcon A toric lens. The study results were not used for design validation of the investigational product.

Eligibility Criteria

Inclusion Criteria

  • A person is eligible for inclusion in the study if they:
  • Are at least 18 years of age 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 -1.75 to -6.00 diopters and
  • Astigmatism: between -1.00 to -2.25 and
  • Axis: 180 ± 20 degrees
  • Are willing to wear contact lenses in both eyes;
  • Have manifest refraction visual acuities (VA) equal to or better than logMAR (log of the minimum angle of resolution) 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

  • A person will be excluded from the study if they:
  • 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 (NCT02555098). 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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