Performance Evaluation of Two Silicone Hydrogel Toric Lens Designs in Habitual Soft Contact Lens Wearers

Astigmatism Clinical Trial

Official title:

Performance Evaluation of Two Silicone Hydrogel Toric Lens Designs in Habitual Soft Contact Lens Wearers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05933772
• Other study ID #: EX-MKTG-149
• Status: Completed
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2023
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to compare the clinical performance of two monthly toric silicone hydrogel contact lenses in habitual wearers, when worn for 1-month each.

Description:

This study is a prospective, bilateral eye, subjected-masked, randomized, 1-month cross-over, daily-wear design involving two different silicone hydrogel toric lens types. Each lens type will be worn bilaterally for approximately one month.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

1. Is between 18 and 39 years of age (inclusive) and has full legal capacity to volunteer;

2. Has read and signed an information consent letter;

3. Self-reports having a full eye examination in the previous two years;

4. Anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week;

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

6. Habitually wears of toric soft contact lenses binocularly.

1. No more than 1/3 of the participants should be wearing daily disposable soft toric lenses;

2. the remaining 2/3+ of the participants must be planned frequent replacement soft

toric lens wearers as follows:

• i. TOTAL30 for Astigmatism: maximum of 3 (~10%) (no target percentage
• ii. Biofinity toric: maximum of 13 (~40%) (PLUS a target of minimum 10 (~30%))
• iii. Air Optix for Astigmatism (inclusive of +Hydraglyde): maximum of 10 (~30%) (PLUS a target of minimum 7 (~20%))
• iv. ULTRA for Astigmatism: maximum of 5 (~15%) (no target percentage)
• v. Acuvue Vita for Astigmatism: maximum of 3 (~10%) (no target percentage)
• vi. Acuvue Oasys for Astigmatism: maximum of 10 (~30%) (no target percentage)
• vii. Other brands of frequent replacement: maximum of 7 (~20%) (no target percentage)

7. Has refractive astigmatism of at least -0.75DC but no more than -2.75DC in each eye that is correctable with a soft toric lens with a cylinder power of no greater than -2.25DC;

8. Is ammetropic and requires a spectacle spherical component of +8.00 to -10.00D inclusively;

9. Can be fit and achieve binocular distance vision of at least 20/32 Snellen with the available lens parameters

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study;

2. Has any known active ocular disease and/or infection that contraindicates contact lens wear;

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

4. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;

5. Has known sensitivity to the diagnostic sodium fluorescein used in the study;

6. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;

7. Has undergone refractive error surgery or intraocular surgery.

Related Conditions & MeSH terms

• Astigmatism

Intervention

Device:
• Lens A (comfilcon A toric lens)
One month wear
• Lens B (lehfilcon A toric lens)
One month wear

Locations

Country	Name	City	State
Canada	Eyes on Sheppard Clinic	Toronto	Ontario
Canada	Spadina Optometry	Toronto	Ontario
United States	ProCare Vision Center	Granville	Ohio
United States	Kannarr Eye Care	Pittsburg	Kansas
United States	Sacco Eye Group	Vestal	New York

Sponsors (2)

Lead Sponsor	Collaborator
Coopervision, Inc.	CORE

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lens Handling on Removal	Lens Handling on Removal, using a 0-100 scale (0= Worst, 100=Best)	One month of wear
Secondary	Distance Visual Acuity	Distance Visual Acuity, using Snellen converted to logMAR	One month wear