A Clinical Comparison of Two Soft Multifocal Contact Lenses

The study objective was to gather short-term clinical performance data for two soft multifocal contact lenses.

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Device: Lens 1; Device: Lens 2

Detailed Description

The aim of this subject-masked, non-randomized, non-dispensing study was to evaluate the short-term clinical performance of a soft multifocal hydrogel contact lens when compared to a soft silicone multifocal hydrogel lens after 15 minutes of daily wear each.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom
    • The University of Manchester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 42 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. They were at least 42 years of age and had capacity to volunteer.
2. They understood their rights as a research subject and were willing and able to sign a Statement of Informed Consent.
3. They had had a full eye examination within the past two years (by self-report).
4. They were willing and able to follow the protocol.
5. They habitually used vision correction for near vision (multifocal soft contact lenses, sphere lenses for monovision, sphere lenses for distance vision correction and spectacles for near vision correction, or had a different spectacle prescription for distance and near vision correction) and had done so for at least the past three months.
6. They had refractive astigmatism of no greater than -0.75DC.
7. They could be fitted with the study lenses within the power range available, and achieved binocular distance HCVA of +0.20 or better in the study lenses.

Exclusion Criteria:

Subjects were not eligible to take part in the study if:

1. They had an ocular disorder which would normally contra-indicate contact lens wear.
2. They had a systemic disorder which would normally contra-indicate contact lens wear.
3. They were using any topical medication such as eye drops or ointment.
4. They were aphakic.
5. They had had corneal refractive surgery.
6. They had any corneal distortion resulting from previous hard or rigid lens wear or had keratoconus.
7. They were pregnant or lactating.
8. They had an eye or health condition including an immunosuppressive or infectious disease which could, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lens 1; Participants wore Lens 1 for 15 minutes (Period 1)	Device: Lens 1; Soft multifocal hydrogel contact lens for 15 minutes
Experimental: Lens 2; Participants wore Lens 2 for 15 minutes (Period 2)	Device: Lens 2; Soft multifocal silicone hydrogel contact lens for 15 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Overall Score	Subjective Overall Score was assessed using the 0-100 visual analogue scale where 0=Extremely poor, cannot use lenses and 100=Excellent=Highly impressed with these lenses overall	15 Minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Comfort	Subjective Comfort Score was assessed using the 0-100 visual analogue scale where 0=Extremely uncomfortable, causes pain, cannot be tolerated and 100=Excellent, cannot be felt	15 Minutes
Subjective Vision	Subjective Vision Score (distance and near) was assessed using the 0-100 visual analogue scale where 0=Unacceptable, cannot be worn and 100=Excellent, unaware of any visual loss	15 Minutes

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Philip Morgan, PhD, MCOptom, Eurolens Research

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): March 23, 2023
• Study Completion (Actual): March 23, 2023

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: March 20, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: C22-726 (EX-MKTG-147)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes