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

Not Applicable

Completed

• Conditions: Astigmatism
• Interventions: Device: Sapphire contact lenses; Device: senofilcon A contact lenses

• Registration Number: NCT02555098
• Lead Sponsor: Coopervision, Inc.

Brief 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.

Detailed Description

This will be a randomized, bilateral, 2-week cross-over, double-masked, dispensing study comparing the investigational test lens against the Senofilcon A Toric for Astigmatism control lens.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-04
• Study First Submitted QC: 2015-09-17
• Study First Posted: 2015-09-21
• Primary Completion: 2016-02
• Study Completion: 2016-04
• Status Verified: 2020-09
• Results First Submitted: 2020-09-02
• Results First Submitted QC: 2020-09-02
• Last Update Submitted: 2020-09-22
• Results First Posted: 2020-09-23
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• A person is eligible for inclusion in the study if they:

  1. Are at least 18 years of age and have full legal capacity to volunteer;

  2. Have read and signed an information consent letter;

  3. Are willing and able to follow instructions and maintain the appointment schedule;

  4. Are an adapted soft contact lens wearer;

  5. Require spectacle lens powers in both eyes;

     1. Sphere: between -1.75 to -6.00 diopters and
     2. Astigmatism: between -1.00 to -2.25 and
     3. Axis: 180 ± 20 degrees

  6. Are willing to wear contact lenses in both eyes;

  7. 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;

  8. 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:

  1. Are participating in any concurrent clinical or research study;
  2. Have any known active* ocular disease and/or infection;
  3. Have a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  4. Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
  5. Have known sensitivity to the diagnostic pharmaceuticals to be used in the study;
  6. Are pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
  7. Are aphakic;
  8. Have undergone refractive error surgery;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sapphire contact lenses	Sapphire contact lenses	Each subject randomized to wear either the Investigational lenses (test) or senofilcon A contact lenses (control) as a matched pair and cross over to the second matched pair.
senofilcon A	senofilcon A contact lenses	Each subject randomized to wear either the Investigational lenses (test) or senofilcon A contact lenses (control) as a matched pair and cross over to the second matched pair.

Primary Outcome Measures

Name	Time	Method
Subjective Overall Preference	2 weeks	Subjective Overall Preference: Sapphire lens, senofilcon A lens, No preference
Subjective Assessment of Visual Quality	2 weeks	Subjective assessment of visual quality assessed on a Scale: 0-100 (0=Extremely poor vision all of the time; Cannot function; 100=Excellent vision all of the time)
Subjective Ratings for Comfort	2 weeks	Scale 0-100; (0=Cannot be worn; 100=Cannot be felt ever)
Subjective Ratings for Comfort Preference	2 weeks	Subjective Ratings for Comfort Preference: Sapphire lens, senofilcon A lens, No preference
Subjective Assessment of Overall Satisfaction	2 weeks	Subjective assessment of overall satisfaction on a Scale: 0-100: (0=Extremely dissatisfied; 100=Extremely satisfied)

Trial Locations

Locations (1)

Family Eye Care Center; 🇺🇸 Campbell, California, United States