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

Astigmatism Clinical Trial

Official title:

A Bilateral Dispensing Clinical Trial of Sapphire Lens Against Senofilcon A Toric for Astigmatism Lens Over 2 Weeks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02555098
• Other study ID #: CV-15-15
• Status: Completed
• Phase: N/A
• 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
• 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;

Related Conditions & MeSH terms

• Astigmatism

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