Comparing the Performance of 1 Day Multifocal Contact Lenses

NCT04449263 | Completed Results FDA Device

• 1 other identifier: EX-MKTG-109
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

Brief Summary

The objective of the study was to compare the lens handling and performance of Lens A to habitually worn multifocal contact lenses and to the competitor Lens B.

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

• Subjective At-home Ratings for Ease of Lens Handling for Insertion

  Subjective at-home ratings for ease of Lens handling for insertion will be assessed using a 0-10 scale, (0=very difficult, 10=very easy)

  Day 13

Study Arms (3)

Lens A (Test)

EXPERIMENTAL

Subjects will be randomized to wear Lens A (test) the control Lens B for 2 weeks in this randomized, cross-over bilateral dispensing study.

Device: Lens A; Device: Lens B; Device: Habitual Lenses

Lens B (Control)

ACTIVE COMPARATOR

Subjects will be randomized to wear Lens B (control) and Lens A (Test) for 2 weeks in this randomized, cross-over bilateral dispensing study.

Device: Lens A; Device: Lens B; Device: Habitual Lenses

Habitual Lenses

ACTIVE COMPARATOR

All subjects will wear their habitual lenses for two weeks prior to randomization of Test lens A and control lens B.

Device: Habitual Lenses

Interventions

Lens A DEVICE

Subjects will be randomized to wear Lens A (test) for 2 weeks.

Also known as: FDA Approved, non-marketed, daily disposable multifocal lens

Lens A (Test); Lens B (Control)

Lens B DEVICE

Subjects will be randomized to wear Lens B (control) for 2 weeks.

Also known as: FDA Approved, daily disposable multifocal lens

Lens A (Test); Lens B (Control)

Habitual Lenses DEVICE

All Subjects will wear their habitual lenses for 2 weeks prior to randomization of test lens and control lens.

Habitual Lenses; Lens A (Test); Lens B (Control)

Eligibility Criteria

• Age: 42 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is at least 42 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, 5 days a week;
• Is willing and able to follow instructions and maintain the appointment schedule;
• Habitually wears multifocal soft contact lenses, for the past 3 months minimum;
• Has refractive astigmatism no higher than -0.75DC;
• Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D;
• Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (sphere +4 to -6; near addition or LOW, MEDIUM, HIGH).

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 (5)

Scripps Poway Eyecare

San Diego, California, 92131, United States

Location

Golden Optometric Group

Whittier, California, 90606, United States

Location

Golden Vision

Sarasota, Florida, 34237, United States

Location

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

Location

ProCare Vision Center

Granville, Ohio, 43023, United States

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Jose Vega, OD, MSc, FAAO
• Organization: CooperVision, Inc

javega2@coopervision.com

9256402964

Study Officials

• Wayne Golden

  Golden Vision

  PRINCIPAL INVESTIGATOR

• Keith Wan

  Scripps Poway Eyecare

  PRINCIPAL INVESTIGATOR

• Shane Kannarr

  Kannarr Eye Care

  PRINCIPAL INVESTIGATOR

• David Ardaya

  Golden Optometric Group

  PRINCIPAL INVESTIGATOR

• Katherine Bickle

  ProCare Vision Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: June 26, 2020
• Study Start: July 27, 2020
• Primary Completion: December 7, 2020
• Study Completion: December 30, 2020
• Last Updated: June 22, 2021
• Results First Posted: June 21, 2021

Record last verified: 2021-06

Locations

US (5)