A Clinical Comparison of Two Soft Multifocal Contact Lenses

NCT ID: NCT05794126

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2023-03-23

Brief Summary

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

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.

Conditions

Presbyopia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lens 1

Participants wore Lens 1 for 15 minutes (Period 1)

Group Type: EXPERIMENTAL

Lens 1

Intervention Type: DEVICE

Soft multifocal hydrogel contact lens for 15 minutes

Lens 2

Participants wore Lens 2 for 15 minutes (Period 2)

Group Type: EXPERIMENTAL

Lens 2

Intervention Type: DEVICE

Soft multifocal silicone hydrogel contact lens for 15 minutes.

Interventions

Lens 1

Soft multifocal hydrogel contact lens for 15 minutes

Intervention Type: DEVICE

Lens 2

Soft multifocal silicone hydrogel contact lens for 15 minutes.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 42 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip Morgan, PhD, MCOptom

Role: PRINCIPAL_INVESTIGATOR

Eurolens Research

Locations

The University of Manchester

Manchester, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

C22-726 (EX-MKTG-147)

Identifier Type: -

Identifier Source: org_study_id