Evaluating Two Multifocal Daily Disposable Contact Lenses

Not Applicable

Completed

• Conditions: Presbyopia
• Interventions: Device: Control Lens; Device: Test Lens

• Registration Number: NCT05579886
• Lead Sponsor: Coopervision, Inc.

Brief Summary

The objective of the study was to adapt existing multifocal soft lens wearers to a Control Lens for at least 2 weeks and then evaluate the success of switching them to the Test Lens, with a review after 2 weeks.

Detailed Description

This prospective, bilateral eye, open label, non-randomized study compared the performance of 2 different designs of daily disposable multifocal contact lenses.

Study Timeline

• Study Start: 2022-10-10
• Study First Submitted: 2022-10-11
• Study First Submitted QC: 2022-10-11
• Study First Posted: 2022-10-14
• Primary Completion: 2023-02-07
• Study Completion: 2023-02-07
• Status Verified: 2024-01
• Results First Submitted: 2024-01-25
• Results First Submitted QC: 2024-01-25
• Last Update Submitted: 2024-01-25
• Results First Posted: 2024-02-20
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

A person was eligible for inclusion in the study if he/she:

1. Was at least 42 years of age and had full legal capacity to volunteer;
2. Had read and signed an information consent letter;
3. Self-reported having had a full eye examination in the previous two years;
4. Anticipated being able to wear the study lenses for at least 8 hours a day, 5 days a week;
5. Was willing and able to follow instructions and maintain the appointment schedule;
6. Habitually wore multifocal soft contact lenses, for the past 3 months minimum (NOTE: the habitual contact lens type was restricted such that no more than one third were to be the clariti 1 day multifocal and no more than one third were to be MyDay multifocal (this included their equivalent private label brand name);
7. Had refractive astigmatism no higher than -0.75DC in each eye;
8. Was presbyopic and required a reading addition of at least +0.75D and no more than +2.50D in each eye;
9. Could be fit and achieved binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deemed to be 'acceptable', with the available study lens parameters (powers +4.00 to -6.00DS)

Exclusion Criteria

A person was excluded from the study if he/she:

1. Was participating in any concurrent clinical or research study;
2. Had any known active ocular disease and/or infection that contraindicated contact lens wear;
3. Had a systemic condition that in the opinion of the investigator may have affected a study outcome variable;
4. Was using any systemic or topical medications that in the opinion of the investigator may have affected contact lens wear or a study outcome variable;
5. Had known sensitivity to the diagnostic sodium fluorescein to be used in the study;
6. Self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment;
7. Had undergone refractive error surgery or interocular surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control Lens	Control Lens	All participants wore the Control Lens for 2 weeks (Period 1)
Test Lens	Test Lens	All participants wore the Test Lens for 2 weeks (Period 2)

Primary Outcome Measures

Name	Time	Method
Comfort Just After Lens Insertion	2 weeks	Subjective rating measured on a scale of 0-10, 0.5 steps, where 0=Painful, 10=Can't feel the lenses.

Trial Locations

Locations (5)

Nittany Eye Associates; 🇺🇸 State College, Pennsylvania, United States

Sacco Eye Group; 🇺🇸 Vestal, New York, United States

Coan Eye Care & Optical Boutique; 🇺🇸 Ocoee, Florida, United States

ProCare Vision Center; 🇺🇸 Granville, Ohio, United States

Kannarr Eye Care; 🇺🇸 Pittsburg, Kansas, United States