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A Clinical Comparison of Two Soft Multifocal Contact Lenses

Primary Purpose

Presbyopia

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Soft Multifocal Hydrogel Contact Lens 1
Soft Multifocal Silicone Hydrogel Contact Lens 2
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia

Eligibility Criteria

42 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: They are at least 42 years of age and have capacity to volunteer. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent. They have had a full eye examination within past two years (by self-report) They are willing and able to follow protocol. They habitually use 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 have a different spectacle prescription for distance and near vision correction) and have done so for at least the past three months. They have refractive astigmatism of no greater than -0.75DC. They are expected to be able to fitted with the study lenses within power range available, and to achieve binocular distance HCVA of +0.20 or better in the study lenses. Exclusion Criteria: They have an ocular disorder which would normally contra-indicate contact lens wear. They have a systemic disorder which would normally contra-indicate contact lens wear. They are using any topical medication such as eye drops or ointment. They are aphakic. They have had corneal refractive surgery. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. They are pregnant or lactating. They have an eye or health condition including an immunosuppressive or infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose risk to study personnel; or a history of anaphylaxis or severe allergic reaction.

Sites / Locations

  • The University of ManchesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Soft Multifocal Hydrogel Contact Lens 1

Soft Multifocal Silicone Hydrogel Contact Lens 2

Arm Description

Participants will wear soft multifocal hydrogel contact lens 1 for the first period of 15 minutes and soft multifocal silicone hydrogel contact lens 2 for the second period of 15 minutes.

Participants will wear soft multifocal silicone hydrogel contact lens 2 for the second period of 15 minutes.

Outcomes

Primary Outcome Measures

Subjective Overall Score
Subjective Overall Score will be assessed using the 0-100 visual analogue scale (0= Extremely poor. Cannot use lenses. and 100=Excellent. Highly impressed with these lenses overall.)

Secondary Outcome Measures

Subjective Comfort
Subjective Comfort Score will be assessed using the 0-100 visual analogue scale (0= Causes pain. Cannot be tolerated. and 100=Excellent. Cannot be felt.)
Subjective Vision
Subjective Vision Score will be assessed using the 0-100 visual analogue scale (0= Unacceptable. Cannot be worn. and 100=Excellent. Unaware of any visual loss.)

Full Information

First Posted
March 20, 2023
Last Updated
March 20, 2023
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05794126
Brief Title
A Clinical Comparison of Two Soft Multifocal Contact Lenses
Official Title
A Clinical Comparison of Two Soft Multifocal Contact Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
April 20, 2023 (Anticipated)
Study Completion Date
April 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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 study was to evaluate the short-term clinical performance of a soft multifocal hydrogel contact lens when compared to soft silicone multifocal hydrogel lens after 15 minutes of daily wear each.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
47 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Soft Multifocal Hydrogel Contact Lens 1
Arm Type
Experimental
Arm Description
Participants will wear soft multifocal hydrogel contact lens 1 for the first period of 15 minutes and soft multifocal silicone hydrogel contact lens 2 for the second period of 15 minutes.
Arm Title
Soft Multifocal Silicone Hydrogel Contact Lens 2
Arm Type
Experimental
Arm Description
Participants will wear soft multifocal silicone hydrogel contact lens 2 for the second period of 15 minutes.
Intervention Type
Device
Intervention Name(s)
Soft Multifocal Hydrogel Contact Lens 1
Intervention Description
soft multifocal hydrogel contact lens 1 - first period of 15 minutes
Intervention Type
Device
Intervention Name(s)
Soft Multifocal Silicone Hydrogel Contact Lens 2
Intervention Description
soft multifocal silicone hydrogel contact lens 2 - second period of 15 minutes.
Primary Outcome Measure Information:
Title
Subjective Overall Score
Description
Subjective Overall Score will be assessed using the 0-100 visual analogue scale (0= Extremely poor. Cannot use lenses. and 100=Excellent. Highly impressed with these lenses overall.)
Time Frame
15 Minutes
Secondary Outcome Measure Information:
Title
Subjective Comfort
Description
Subjective Comfort Score will be assessed using the 0-100 visual analogue scale (0= Causes pain. Cannot be tolerated. and 100=Excellent. Cannot be felt.)
Time Frame
15 Minutes
Title
Subjective Vision
Description
Subjective Vision Score will be assessed using the 0-100 visual analogue scale (0= Unacceptable. Cannot be worn. and 100=Excellent. Unaware of any visual loss.)
Time Frame
15 Minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: They are at least 42 years of age and have capacity to volunteer. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent. They have had a full eye examination within past two years (by self-report) They are willing and able to follow protocol. They habitually use 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 have a different spectacle prescription for distance and near vision correction) and have done so for at least the past three months. They have refractive astigmatism of no greater than -0.75DC. They are expected to be able to fitted with the study lenses within power range available, and to achieve binocular distance HCVA of +0.20 or better in the study lenses. Exclusion Criteria: They have an ocular disorder which would normally contra-indicate contact lens wear. They have a systemic disorder which would normally contra-indicate contact lens wear. They are using any topical medication such as eye drops or ointment. They are aphakic. They have had corneal refractive surgery. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. They are pregnant or lactating. They have an eye or health condition including an immunosuppressive or infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose risk to study personnel; or a history of anaphylaxis or severe allergic reaction.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jose A Vega, OD,MSc,FAAO
Phone
925-621-3761
Email
javega@coopervision.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Morgan, PhD, MCOptom
Organizational Affiliation
Eurolens Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Manchester
City
Manchester
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip Morgan
Phone
+441613064441
Email
philip.morgan@manchester.ac.uk
First Name & Middle Initial & Last Name & Degree
Philip Morgan, PhD, MCOptom

12. IPD Sharing Statement

Learn more about this trial

A Clinical Comparison of Two Soft Multifocal Contact Lenses

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