Visual Performance of Dailies Total1 Multifocal and Acuvue Oasys Max 1-Day Multifocal in Presbyopic Lens Wearers

Presbyopia Clinical Trial

— GIRAFFE  

Official title:

Visual Performance of Dailies Total1 Multifocal and Acuvue Oasys Max 1-Day Multifocal in Presbyopic Lens Wearers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06369987
• Other study ID #: 46238
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: October 2024

Study information

• Verified date: April 2024
• Source: University of Waterloo
• Contact: Jill Woods, MSc, MCOptom
• Phone: 519-888-4567
• Email: jwoods[@]uwaterloo.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to measure the logMAR visual acuity when presbyopic soft lens wearers are fit with Dailies Total1 Multifocal and ACUVUE OASYS MAX 1-DAY Multifocal.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 42 Years and older

Eligibility

Inclusion Criteria:

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

2. Have signed an information consent letter;

3. Are willing and able to follow instructions and maintain the appointment schedule;

4. Habitually wears soft contact lenses for the past 3 months (minimum);

5. Are presbyopic and require a reading addition of at least +0.75D and no more than +1.75D;

6. Can be refracted and achieve monocular spectacle distance vision of at least 20/25 Snellen (or +0.10logMAR) visual acuity;

7. Have contact lens power requirements that fall within the available study lens parameters (distance sphere: +6D to -9D; near addition as per each lens design);

8. Can be fit with the initial fitting guidelines provided by the lens manufacturer and use either Low or Medium Add (same add in both eyes).

Exclusion Criteria:

1. Are a current habitual wearer of Dailies Total1 Multifocal or ACUVUE OASYS MAX 1-DAY Multifocal;

2. Has refractive astigmatism higher than -0.75DC in either eye;

3. Are participating in any concurrent clinical or research study involving intervention or invasive ocular tests;

4. Have any known active ocular disease and/or infection;

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

6. Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;

7. Have known sensitivity to the diagnostic pharmaceuticals to be used in the study;

8. Have undergone refractive error surgery;

9. Are a member of the Centre for Ocular Research & Education (CORE) directly involved in the study.

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• Deleficon A (multifocal)
Daily disposable silicone hydrogel contact lenses indicated for presbyopia, in addition to myopia or hyperopia.
• Senofilcon A (multifocal)
Daily disposable silicone hydrogel contact lenses indicated for presbyopia, in addition to myopia or hyperopia

Locations

Country	Name	City	State
Canada	Centre for Ocular Research & Education (CORE)	Waterloo	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Waterloo	Alcon Research

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High contrast visual acuity (logMAR) at 6m	High contrast visual acuity (logMAR) for the dominant eye under photopic illumination at 6m	Day 1
Primary	High contrast visual acuity (logMAR) at 40cm	High contrast visual acuity (logMAR) for the dominant eye under photopic illumination at 40cm	Day 1