To Evaluate The Performance Of Two Monthly Replacement Silicone Hydrogel Contact Lenses After 1-month Of Wear

Myopia Clinical Trial

Official title:

To Evaluate The Performance Of Two Monthly Replacement Silicone Hydrogel Contact Lenses After 1-month Of Wear

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05333965
• Other study ID #: EX-MKTG-132
• Status: Completed
• Phase: N/A
• Start date: April 27, 2022
• Est. completion date: September 13, 2022

Study information

• Verified date: April 2022
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the performance of two monthly replacement silicone hydrogel contact lenses in habitual FRP CL wearers when worn for 1-month.

Description:

This study will be a prospective, randomized, double-masked, single-site, 1-month cross-over design involving bilateral eye daily wear of two different monthly replacement CL types. Each lens will be worn bilaterally for approximately one month.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 13, 2022
• Est. primary completion date: September 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

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

2. Self-reports having had a full eye examination within the previous 2 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 a habitual wearer of frequent replacement contact lenses;

6. Anticipates no difficulty wearing the contact lenses for 6 days/week and 8 hours/day during the study;

7. Has refractive astigmatism no higher than -0.75DC in each eye;

8. Can be successfully fit with both study lens types;

9. Achieves at least 0.4 logMAR VA monocularly and at least 0.2 logMAR VA binocularly with each study lens type.

Exclusion Criteria:

1. Is participating in any concurrent clinical research study;

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

3. Has an unstable systemic condition that in the opinion of the investigator may affect vision or contact lens comfort across the 2-month study duration;

4. Is using any systemic or topical medications in an irregular routine that in the opinion of the investigator may affect vision or contact lens comfort across the 2-month study duration;

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

6. Is an employee of the Centre for Ocular Research & Education.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Lens A (lehfilcon A lens)
Daily wear for 1 month.
• Lens B (comfilcon A lens)
Daily wear for 1 month.

Locations

Country	Name	City	State
Canada	School of Optometry & Vision Science	Waterloo

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lens Handling on Lens Removal	Lens handling on removal will be measured on a scale of 0-10, 0.5 steps (0=Completely dissatisfied,10=Completely satisfied)	1 month