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

NCT05333965 | Completed Results DMC FDA Device

• 1 other identifier: EX-MKTG-132
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Lens A, Then Lens B

EXPERIMENTAL

Participants wore Lens A for one month and then crossed over to wear Lens B for one month.

Device: Lens A (lehfilcon A lens); Device: Lens B (comfilcon A lens)

Lens B, Then Lens A

EXPERIMENTAL

Participants wore Lens B for one month and then crossed over to wear Lens A for one month.

Device: Lens A (lehfilcon A lens); Device: Lens B (comfilcon A lens)

Interventions

Lens A (lehfilcon A lens) DEVICE

Daily wear for 1 month.

Lens A, Then Lens B; Lens B, Then Lens A

Lens B (comfilcon A lens) DEVICE

Daily wear for 1 month.

Lens A, Then Lens B; Lens B, Then Lens A

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Is at least 17 years of age and has full legal capacity to volunteer;
• Self-reports having had a full eye examination within the previous 2 years;
• Has read and signed an information consent letter;
• Is willing and able to follow instructions and maintain the appointment schedule;
• Is a habitual wearer of frequent replacement contact lenses;
• Anticipates no difficulty wearing the contact lenses for 6 days/week and 8 hours/day during the study;
• Has refractive astigmatism no higher than -0.75DC in each eye;
• Can be successfully fit with both study lens types;
• Achieves at least 0.4 logMAR VA monocularly and at least 0.2 logMAR VA binocularly with each study lens type.

You may not qualify if:

• Is participating in any concurrent clinical research study;
• Has any known active ocular disease and/or infection;
• 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;
• 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;
• Has known sensitivity to the diagnostic sodium fluorescein to be used in the study;
• Is an employee of the Centre for Ocular Research \& Education.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

School of Optometry & Vision Science

Waterloo, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Jose A. Vega, OD, MSc, FAAO
• Organization: CooperVision

jvega2@coopervision.com

9256213761

Study Officials

• Lyndon Jones, PhD FCOptom

  Centre for Ocular Research and Education

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 19, 2022
• Study Start: April 27, 2022
• Primary Completion: September 13, 2022
• Study Completion: September 13, 2022
• Last Updated: October 23, 2023
• Results First Posted: October 23, 2023

Record last verified: 2022-04

Locations

CA (1)