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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date September 2020
Source Coopervision, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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;

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Sapphire contact lenses
Each subject randomized to wear either the test or control contact lenses as a matched pair and cross over to the second matched pair
senofilcon A contact lenses
Each subject randomized to wear either the test or control contact lenses as a matched pair and cross over to the second matched pair

Locations

Country Name City State
United States Family Eye Care Center Campbell California

Sponsors (1)

Lead Sponsor Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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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