Evaluation of the Performance of Different Daily Disposable Lens Designs in Habitual Soft Contact Lens Wearers

NCT04668989 | Completed Results DMC FDA Device

• 1 other identifier: EX-MKTG-118
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 4

Brief Summary

The main objective of the study is to refit existing soft lens wearers with two different daily disposable contact lens types, Lens A and Lens B, to determine their performance after one week of wear.

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• Lens Wettability

  Lens wettability on a 0 to 4 descriptive scale, 0.5 steps (0 - Very poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 - Poor: Irregular surface appearance, drying time \<\< blink time, 2 - Acceptable: Smooth surface appearance immediately after the blink becoming irregular after a while, drying time ≤ blink time, 3 - Good: Typical soft lens appearance with long drying time, 4 - Excellent: Appearance similar to a healthy cornea with very long drying time)

  Baseline - after 2 hours of lens wear

• Lens Wettability

  Lens wettability on a 0 to 4 descriptive scale, 0.5 steps (0 - Very poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 - Poor: Irregular surface appearance, drying time \<\< blink time, 2 - Acceptable: Smooth surface appearance immediately after the blink becoming irregular after a while, drying time ≤ blink time, 3 - Good: Typical soft lens appearance with long drying time, 4 - Excellent: Appearance similar to a healthy cornea with very long drying time)

  1 week

Study Arms (2)

stenfilcon A - (Test lens)

EXPERIMENTAL

Subjects will be randomized to wear test lenses for one week then cross-over to the control lenses for one week.

Device: stenfilcon A - (Test lens); Device: kalifilcon A - (Control Lens)

kalifilcon A - (Control Lens)

ACTIVE COMPARATOR

Subjects will be randomized to wear control lenses for one week then cross-over to the test lenses for one week.

Device: stenfilcon A - (Test lens); Device: kalifilcon A - (Control Lens)

Interventions

stenfilcon A - (Test lens) DEVICE

Subjects will be randomized to wear test lenses for one week.

kalifilcon A - (Control Lens); stenfilcon A - (Test lens)

kalifilcon A - (Control Lens) DEVICE

Subjects will be randomized to wear control lenses for one week.

kalifilcon A - (Control Lens); stenfilcon A - (Test lens)

Eligibility Criteria

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

You may qualify if:

• Is at least 18 years of age and has full legal capacity to volunteer;
• Has read and signed an information consent letter;
• Self reports having a full eye examination in the previous two years;
• Anticipates being able to wear the study lenses for at least 8 hours a day, 7 days a week;
• Is willing and able to follow instructions and maintain the appointment schedule;
• Habitually wears soft contact lenses, for the past 3 months minimum;
• 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 -1.00 to -6.00D, 0.25D steps).

You may not qualify if:

• Is participating in any concurrent clinical or research study;
• Habitually wears one of the study contact lenses;
• Has any known active\* ocular disease and/or infection that contraindicates contact lens wear;
• Has a systemic 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, PLLC

Vestal, New York, 13850, United States

Location

Athens Eye Care

Athens, Ohio, 45701, United States

Location

Nittany Eye Associates

College, Pennsylvania, 16801, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Jose A. Vega, O.D., MSc, FAAO
• Organization: Coopervision

jvega2@coopervision.com

9256213761

Study Officials

• Lyndon Jones, PhD

  Centre for Ocular Research & 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: December 4, 2020
• First Posted: December 16, 2020
• Study Start: November 1, 2020
• Primary Completion: February 5, 2021
• Study Completion: February 5, 2021
• Last Updated: September 16, 2021
• Results First Posted: September 16, 2021

Record last verified: 2021-09

Locations

US (4)