Clinical trial NCT02555098: A Bilateral Dispensing Clinical Trial of an Sapphire Lens Against Senofilcon A Toric for Astigmatism Lens
Official title: A Bilateral Dispensing Clinical Trial of Sapphire Lens Against Senofilcon A Toric for Astigmatism Lens Over 2 Weeks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2015-09-21
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Subjective Ratings for Comfort
timeFrame: Baseline (10 minutes post lens settling)
measure: Subjective Ratings for Comfort
timeFrame: 2 weeks
measure: Subjective Ratings for Comfort Preference
timeFrame: Baseline (10 minutes post lens settling)
measure: Subjective Ratings for Comfort Preference
timeFrame: 2 weeks
measure: Subjective Assessment of Visual Quality
timeFrame: Baseline (10 minutes post lens settling)
measure: Subjective Assessment of Visual Quality
timeFrame: 2 weeks
measure: Subjective Assessment of Overall Satisfaction
timeFrame: Baseline (10 minutes post lens settling)
measure: Subjective Assessment of Overall Satisfaction
timeFrame: 2 weeks
measure: Subjective Overall Preference
timeFrame: Baseline (10 minutes post lens settling)
measure: Subjective Overall Preference
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Campbell
country: United States
facility: Family Eye Care Center
state: California
Study officials:
affiliation: Ocular Technology Group
name: Michel Guillon
role: PRINCIPAL_INVESTIGATOR
References: