Comparing the Performance of 1 Day Multifocal Contact Lenses

Presbyopia Clinical Trial

Official title:

Comparing the Performance of 1 Day Multifocal Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04449263
• Other study ID #: EX-MKTG-109
• Status: Completed
• Phase: N/A
• Start date: July 27, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: June 2021
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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. This was a prospective, randomized, participant-masked, crossover, bilateral dispensing study conducted at up to 5 clinical practice sites in the United States. Subjects were dispensed their habitual lenses for two weeks prior to randomization of Test Lens and Control Lens. Each lens type will be worn for 2 weeks after randomization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 30, 2020
• Est. primary completion date: December 7, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 42 Years and older

Eligibility

Inclusion Criteria:

1. Is at least 42 years of age and has full legal capacity to volunteer;

2. Has read and signed an information consent letter;

3. Self reports having a full eye examination in the previous two years;

4. Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week;

5. Is willing and able to follow instructions and maintain the appointment schedule;

6. Habitually wears multifocal soft contact lenses, for the past 3 months minimum;

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

8. Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D;

9. 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).

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study;

2. Habitually wears one of the study contact lenses;

3. Has any known active* ocular disease and/or infection that contraindicates contact lens wear;

4. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;

5. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;

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

7. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;

8. Has undergone refractive error surgery or intraocular surgery.

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• Lens A
Subjects will be randomized to wear Lens A (test) for 2 weeks.
• Lens B
Subjects will be randomized to wear Lens B (control) for 2 weeks.
• Habitual Lenses
All Subjects will wear their habitual lenses for 2 weeks prior to randomization of test lens and control lens.

Locations

Country	Name	City	State
United States	ProCare Vision Center	Granville	Ohio
United States	Kannarr Eye Care	Pittsburg	Kansas
United States	Scripps Poway Eyecare	San Diego	California
United States	Golden Vision	Sarasota	Florida
United States	Golden Optometric Group	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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