A Bilateral Dispensing Comparison of Comfilcon A Over Senofilcon C Contact Lenses

Astigmatism Bilateral Clinical Trial

Official title:

A Bilateral Dispensing Comparison of Biofinity Toric and Acuvue Vita for Astigmatism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03684928
• Other study ID #: EX-MKTG-94
• Status: Completed
• Phase: N/A
• Start date: July 23, 2018
• Est. completion date: February 1, 2019

Study information

• Verified date: April 2019
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the subjective acceptance of Comfilcon A contact lenses when worn on a daily wear modality over one month.

Description:

This study is a 30-subjects prospective, double-masked (investigator and participant), bilateral, randomized, one month cross-over dispensing study comparing subject acceptance of Comfilcon A against Senofilcon A contact lenses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 1, 2019
• Est. primary completion date: December 14, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

1. Is at least 17 years of age and has full legal capacity to volunteer;

2. Has had a self-reported oculo-visual examination in the last two years.

3. Has read and signed an information consent letter;

4. Is willing and able to follow instructions and maintain the appointment schedule;

5. Is an adapted soft contact lens wearer, who currently wears contact lenses for a minimum 3 days/week and 8 hours/day AND who anticipates no difficulty wearing CLs for 6 days/week, 10 hours /day.

6. Is willing to wear contact lens in both eyes for the duration of the study;

7. Has a minimum astigmatism of - 0.75, determined by refraction;

8. Can be fit with the two study contact lens types in the powers available;

9. Has a distance visual acuity of 0.20 logMAR (approx 20/30) or better, determined by refraction;

10. Can achieve a distance visual acuity of 0.20 logMAR (approx 20/30) or better in each eye with the study contact lenses.

11. Has clear corneas and no active* ocular disease;

Exclusion Criteria:

A person will be excluded from the study if he/she:

1. Is participating in any concurrent clinical trial;

2. Has any known active* ocular disease and/or infection;

3. Has a systemic condition that in the opinion of the investigator may affect a study measure;

4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study measure;

5. Has known sensitivity to fluorescein dye or products to be used in the study;

6. Appears to have any active* ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses;

7. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);

8. Is aphakic;

9. Has undergone refractive error surgery;

10. Has participated in the previous QUENA study.

Related Conditions & MeSH terms

• Astigmatism
• Astigmatism Bilateral

Intervention

Device:
• Comfilcon A (test)
Daily wear contact lenses
• Senofilcon C (control)
Daily wear contact lenses

Locations

Country	Name	City	State
Canada	University Of Waterloo	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ease of Insertion(Handling)	Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)	Baseline
Primary	Ease of Insertion (Handling)	Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)	2 weeks
Primary	Ease of Insertion(Handling)	Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)	1 month
Secondary	Rotational Recovery After Lens Mislocation	Lens relocation after 10 blinks, after 30º rotation mislocation	Baseline
Secondary	Rotational Recovery After Lens Mislocation	Lens relocation after 10 blinks, after 30º rotation mislocation.	1 month