Comparison of Comfilcon A Toric Contact Lenses and Samfilcon A Toric Contact Lenses

Astigmatism Clinical Trial

Official title:

A Bilateral Dispensing Comparison of Biofinity Toric and Ultra for Astigmatism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03519932
• Other study ID #: EX-MKTG-91
• Status: Completed
• Phase: N/A
• Start date: April 30, 2018
• Est. completion date: February 1, 2019

Study information

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

Clinical Trial Summary

The objective of this study is to evaluate the subjective acceptance of comfilcon A toric contact lens, compared to samfilcon A toric lens.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: February 1, 2019
• Est. primary completion date: October 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

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

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

• Has read and signed an information consent letter;

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

• 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.

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

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

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

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

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

• Has clear corneas and no active* ocular disease

Exclusion Criteria:

• Is participating in any concurrent clinical trial;

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

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

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

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

• 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;

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

• Is aphakic;

• Has undergone refractive error surgery.

• Has participated in the PIANO (i.e. EX-MKTG-83) Study.

Related Conditions & MeSH terms

• Astigmatism

Intervention

Device:
• comfilcon A toric lens
Contact lens
• samfilcon A toric lens
Contact lens

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	Comfort at Insertion	Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)	Dispense
Primary	Comfort	Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)	2 weeks
Primary	Comfort	Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)	1-month
Primary	Lens Preference Based on Overall Comfort	Lens preference with respect to comfort (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference)	1 month
Primary	Lens Preference Based on Overall Dryness	Lens preference with respect to dryness (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference)	1 month
Primary	Dryness	Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness)	2 weeks
Primary	Dryness	Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness)	1-month
Secondary	Ease of Insertion	Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)	Dispense
Secondary	Ease of Insertion	Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)	2-weeks
Secondary	Ease of Insertion	Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)	1-month
Secondary	Ease of Removal	Subjective rating of ease of removing the lens from the eye (scale 0-10; 0=very difficult, 10=very easy)	2-weeks
Secondary	Ease of Removal	Subjective rating of ease of removing the lens from the eye (scale 0-10; 0=very difficult, 10=very easy)	1 month