Evaluation of the Performance of Monthly Replacement Sphere Lens Designs in Habitual Soft Contact Lens Wearers

NCT05114564 | Completed Results FDA Device

• 1 other identifier: EX-MKTG-129
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 4

Brief Summary

The objective of the study is to evaluate the clinical performance of two monthly silicone hydrogel contact lenses in habitual wearers of frequent replacement (FRP) lenses when worn for one month.

Conditions

Myopia; Hyperopia

Outcome Measures

Primary Outcomes (1)

• Subjective Ratings on Lens Handling on Removal

  Subjective Ratings on Lens handling on removal (0-10 scale, 0.5 steps; 10=very easy, 0=very difficult)

  Day 27

Study Arms (2)

Lens A, Then Lens B

EXPERIMENTAL

Participants will wear Lens A for one month and then cross over to wear Lens B for one month.

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

Lens B, Then Lens A

EXPERIMENTAL

Participants will wear Lens B for one month and then cross over to wear Lens A for one month.

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

Interventions

Lens A (comfilcon A lens) DEVICE

1 month

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

Lens B (lehfilcon A lens) DEVICE

1 month

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

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is at least 18 years of age and no older than 35 years, and has full legal capacity to volunteer;
• Has read and signed an information consent letter;
• Is willing and able to follow instructions and maintain the appointment schedule;
• Self-reports having a full eye examination in the previous two years;
• Self-reports spending on most days at least 6 hours cumulative (not necessarily in one single stretch) using digital devices such as a computer, laptop, tablet, e-reader, smartphone;
• Has healthy eyes with no health condition or medication that contra-indicate contact lens wear, in the opinion of the investigator;
• Anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week;
• Habitually wears soft frequent replacement contact lenses, for the past 3 months minimum (NOTE: the habitual contact lens brand is restricted such that no more than one third are to be the Biofinity brand (or their equivalent private label brand name) and no more than one third are to be an Alcon brand;
• Has refractive astigmatism no higher than -0.75DC in each eye;
• Can be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere +6.00 to -6.00D, 0.25D steps).

You may not qualify if:

• Is participating in any concurrent clinical or research study;
• Has any known active ocular disease and/or infection that contraindicates contact lens wear;
• Has a systemic or ocular condition that in the opinion of the investigator may affect a study outcome variable;
• Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
• Has known sensitivity to the diagnostic sodium fluorescein used in the study;
• Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
• Has undergone refractive error surgery or intraocular surgery.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (4)

Complete Eye Care of Medina

Medina, Minnesota, 55340, United States

Location

Sacco Eye Group

Vestal, New York, 13850, United States

Location

Athens Eye Care

Athens, Ohio, 45701, United States

Location

ProCare Vision Center

Granville, Ohio, 43023, United States

Location

MeSH Terms

Conditions

Myopia; Hyperopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: José A. Vega, O.D., MSc., FAAO
• Organization: CooperVision

JVega2@coopervision.com

925-621-3761

Study Officials

• Lyndon Jones, PhD FCOptom

  Centre for Ocular Research and Education

  STUDY DIRECTOR

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: October 29, 2021
• First Posted: November 10, 2021
• Study Start: November 19, 2021
• Primary Completion: April 22, 2022
• Study Completion: April 22, 2022
• Last Updated: April 4, 2023
• Results First Posted: April 4, 2023

Record last verified: 2023-03

Locations

US (4)