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A Clinical Performance of Two Soft Toric Contact Lenses

Primary Purpose

Astigmatism

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Lens 1
Lens 2
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Astigmatism

Eligibility Criteria

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

Inclusion Criteria: They are of legal age (18) and capacity to volunteer. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent. They are willing and able to follow the protocol. They currently wear soft contact lenses, or have done so within the past two years. They have ocular astigmatism in both eyes of between 0.75DC and 3.00DC. They are expected to be able to be fitted with the study lenses within the power range available. 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 a risk to study personnel; or a history of anaphylaxis or severe allergic reaction. They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.

Sites / Locations

  • Eurolens Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Lens 1

Lens 2

Arm Description

Subjects will wear Lens 1 for the first period of 15 minutes and Lens 2 for the second period of 15 minutes.

Subjects will wear Lens 2 for the second period of 15 minutes.

Outcomes

Primary Outcome Measures

Subjective Overall Score
Subjective Overall Score will be assessed using 0-100 visual analogue scales where 0=Extremely poor, 100=Excellent

Secondary Outcome Measures

Comfort
Comfort will be assessed using 0-100 visual analogue scales where 0=Causes pain,100=Excellent
Vision
Vision will be assessed using 0-100 visual analogue scales where 0=Unacceptable,100=Excellent

Full Information

First Posted
November 21, 2022
Last Updated
November 21, 2022
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05633082
Brief Title
A Clinical Performance of Two Soft Toric Contact Lenses
Official Title
A Clinical Performance of Two Soft Toric Contact Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 21, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

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 toric contact lenses.
Detailed Description
This subject-masked, non-randomized, controlled non-dispensing study was to compare the performance of two soft toric lenses, in a single study visit.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Lens 1
Arm Type
Active Comparator
Arm Description
Subjects will wear Lens 1 for the first period of 15 minutes and Lens 2 for the second period of 15 minutes.
Arm Title
Lens 2
Arm Type
Experimental
Arm Description
Subjects will wear Lens 2 for the second period of 15 minutes.
Intervention Type
Device
Intervention Name(s)
Lens 1
Other Intervention Name(s)
Toric Contact Lens
Intervention Description
Lens 1 - first period of 15 minutes
Intervention Type
Device
Intervention Name(s)
Lens 2
Other Intervention Name(s)
Toric Contact Lens
Intervention Description
Lens 2 - second period of 15 minutes
Primary Outcome Measure Information:
Title
Subjective Overall Score
Description
Subjective Overall Score will be assessed using 0-100 visual analogue scales where 0=Extremely poor, 100=Excellent
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Comfort
Description
Comfort will be assessed using 0-100 visual analogue scales where 0=Causes pain,100=Excellent
Time Frame
15 minutes
Title
Vision
Description
Vision will be assessed using 0-100 visual analogue scales where 0=Unacceptable,100=Excellent
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: They are of legal age (18) and capacity to volunteer. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent. They are willing and able to follow the protocol. They currently wear soft contact lenses, or have done so within the past two years. They have ocular astigmatism in both eyes of between 0.75DC and 3.00DC. They are expected to be able to be fitted with the study lenses within the power range available. 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 a risk to study personnel; or a history of anaphylaxis or severe allergic reaction. They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.
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
Eurolens Research
City
Manchester
ZIP/Postal Code
M13 9PL
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Clinical Performance of Two Soft Toric Contact Lenses

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