Astigmatism Clinical Trial
Official title:
A Bilateral Dispensing Clinical Trial of Sapphire Lens Against Senofilcon A Toric for Astigmatism Lens Over 2 Weeks
NCT number | NCT02555098 |
Other study ID # | CV-15-15 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2015 |
Est. completion date | April 2016 |
Verified date | September 2020 |
Source | Coopervision, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 23 |
Est. completion date | April 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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; |
Country | Name | City | State |
---|---|---|---|
United States | Family Eye Care Center | Campbell | California |
Lead Sponsor | Collaborator |
---|---|
Coopervision, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Subjective Ratings for Comfort | Scale 0-100; (0=Cannot be worn; 100=Cannot be felt ever) | Baseline (10 minutes post lens settling) | |
Primary | Subjective Ratings for Comfort | Scale 0-100; (0=Cannot be worn; 100=Cannot be felt ever) | 2 weeks | |
Primary | Subjective Ratings for Comfort Preference | Subjective Ratings for Comfort Preference: Sapphire lens, senofilcon A lens, No preference | Baseline (10 minutes post lens settling) | |
Primary | Subjective Ratings for Comfort Preference | Subjective Ratings for Comfort Preference: Sapphire lens, senofilcon A lens, No preference | 2 weeks | |
Primary | Subjective Assessment of Visual Quality | 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) | Baseline (10 minutes post lens settling) | |
Primary | Subjective Assessment of Visual Quality | 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) | 2 weeks | |
Primary | Subjective Assessment of Overall Satisfaction | Subjective assessment of overall satisfaction on a Scale: 0-100: (0=Extremely dissatisfied; 100=Extremely satisfied) | Baseline (10 minutes post lens settling) | |
Primary | Subjective Assessment of Overall Satisfaction | Subjective assessment of overall satisfaction on a Scale: 0-100: (0=Extremely dissatisfied; 100=Extremely satisfied) | 2 weeks | |
Primary | Subjective Overall Preference | Subjective Overall Preference: Sapphire lens, senofilcon A lens, No preference | Baseline (10 minutes post lens settling) | |
Primary | Subjective Overall Preference | Subjective Overall Preference: Sapphire lens, senofilcon A lens, No preference | 2 weeks |
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