Back to results

The Comparative Clinical Performance of Two Daily Disposable Toric Contact Lenses

Primary Purpose

Astigmatism, Myopia

Status

Active

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Lens A (Test)

Lens B (control)

About this trial

This is an interventional treatment trial for Astigmatism

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

They are aged between 18 and 40 years 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 are willing and able to follow the protocol.
They currently wear soft contact lenses or have done so in the past two years.
They have a spherical component of their contact lens prescription between Plano to - 6.00DS (inclusive).
They have a cylindrical component of their contact lens prescription between -0.75DC and -2.50DC (inclusive).
They can be satisfactorily fitted with the study lens types.
At dispensing, they can attain at least 6/12 distance high contrast visual acuity in each eye with the study lenses within the available power range.
They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
They own a wearable pair of spectacles.
They agree not to participate in other clinical research while enrolled on this study.

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 breastfeeding.
They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
They have eye or health conditions including immunosuppressive or infectious diseases, 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 are currently wearing one of the study contact lenses.
They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

Sites / Locations

Cameron Optometry
Simon Falk Eyecare
Phipps Opticians

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lens A (Test)

Lens B (Control)

Arm Description

Subjects will be randomized to wear Lens A (Test) toric lens for one week.

Subjects will be randomized to wear Lens B (control) toric lens for one week.

Outcomes

Primary Outcome Measures

Subjective handling ratings on lens removal

Subjective handling ratings on lens removal will be measured on a scale of 0-100 (0- Unmanageable, 20- Very poor , 40 - Poor, 60- Good, 80- Very good, 100- Excellent unsuccessful removal, 40 -

Secondary Outcome Measures

Lens Fit - Horizontal Centration

Lens Fit - Horizontal Centration will be measured on a five point scale -2 to +2 (-2 Extremely nasal, -1 Slightly nasal, 0 = Optimum, +1 Slightly temporal, +2 Extremely temporal)

Lens Fit - Vertical centration

Lens Fit - Vertical Centration will be measured on a five point scale of -2 to +2 (-2 Extremely inferior, -1 Slightly inferior, 0= Optimum, +1 Slightly Superior, +2 Extremely Superior)

Corneal Coverage

Corneal Coverage will be measured on a five point scale 0f -2 to +2 (-2 Extremely inadequate, -1 Slightly inadequate, 0- Optimum, +1 Slightly excessive, +2 Extremely excessive)

Lens Movement

Lens Movement will be measured on a five point scale of -2 to +2 (-2 Extremely inadequate, -1 Slightly inadequate, 0- Optimum, +1 Slightly excessive, +2 Extremely excessive)

Full Information

NCT ID

NCT05020990

First Posted

August 19, 2021

Last Updated

May 4, 2022

Sponsor

Coopervision, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05020990

Brief Title

The Comparative Clinical Performance of Two Daily Disposable Toric Contact Lenses

Official Title

The Comparative Clinical Performance of Two Daily Disposable Toric Contact Lenses

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 1, 2022 (Actual)

Primary Completion Date

September 30, 2022 (Anticipated)

Study Completion Date

October 31, 2022 (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

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study aims to compare the clinical performance of two daily disposable toric contact lenses.

Detailed Description

This will be a multi-centre, randomised, open-label, crossover, bilateral study, controlled by cross-comparison. Up to 55 subjects will use each lens type for a week in random sequence. Follow-up visits for each lens will be performed after one week of wear. Lenses will be worn on a daily wear, daily disposable wear schedule.

6. Conditions and Keywords

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

Astigmatism, Myopia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lens A (Test)

Arm Type

Experimental

Arm Description

Subjects will be randomized to wear Lens A (Test) toric lens for one week.

Arm Title

Lens B (Control)

Arm Type

Active Comparator

Arm Description

Subjects will be randomized to wear Lens B (control) toric lens for one week.

Intervention Type

Device

Intervention Name(s)

Lens A (Test)

Intervention Description

Test toric lens

Intervention Type

Device

Intervention Name(s)

Lens B (control)

Intervention Description

Control toric lens

Primary Outcome Measure Information:

Title

Subjective handling ratings on lens removal

Description

Subjective handling ratings on lens removal will be measured on a scale of 0-100 (0- Unmanageable, 20- Very poor , 40 - Poor, 60- Good, 80- Very good, 100- Excellent unsuccessful removal, 40 -

Time Frame

One week.

Secondary Outcome Measure Information:

Title

Lens Fit - Horizontal Centration

Description

Lens Fit - Horizontal Centration will be measured on a five point scale -2 to +2 (-2 Extremely nasal, -1 Slightly nasal, 0 = Optimum, +1 Slightly temporal, +2 Extremely temporal)

Time Frame

One Week

Title

Lens Fit - Vertical centration

Description

Lens Fit - Vertical Centration will be measured on a five point scale of -2 to +2 (-2 Extremely inferior, -1 Slightly inferior, 0= Optimum, +1 Slightly Superior, +2 Extremely Superior)

Time Frame

One week

Title

Corneal Coverage

Description

Corneal Coverage will be measured on a five point scale 0f -2 to +2 (-2 Extremely inadequate, -1 Slightly inadequate, 0- Optimum, +1 Slightly excessive, +2 Extremely excessive)

Time Frame

One week

Title

Lens Movement

Description

Lens Movement will be measured on a five point scale of -2 to +2 (-2 Extremely inadequate, -1 Slightly inadequate, 0- Optimum, +1 Slightly excessive, +2 Extremely excessive)

Time Frame

One week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: They are aged between 18 and 40 years 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 are willing and able to follow the protocol. They currently wear soft contact lenses or have done so in the past two years. They have a spherical component of their contact lens prescription between Plano to - 6.00DS (inclusive). They have a cylindrical component of their contact lens prescription between -0.75DC and -2.50DC (inclusive). They can be satisfactorily fitted with the study lens types. At dispensing, they can attain at least 6/12 distance high contrast visual acuity in each eye with the study lenses within the available power range. They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day). They own a wearable pair of spectacles. They agree not to participate in other clinical research while enrolled on this study. 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 breastfeeding. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear. They have eye or health conditions including immunosuppressive or infectious diseases, 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 are currently wearing one of the study contact lenses. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philip Morgan

Organizational Affiliation

Eurolens Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cameron Optometry

City

Edinburgh

State/Province

Edinburg

ZIP/Postal Code

EH3 6SW

Country

United Kingdom

Facility Name

Simon Falk Eyecare

City

Oakwood

State/Province

Leeds

ZIP/Postal Code

LS8 2HU

Country

United Kingdom

Facility Name

Phipps Opticians

City

Heckmondwike

ZIP/Postal Code

WF16 0EZ

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

The Comparative Clinical Performance of Two Daily Disposable Toric Contact Lenses

We'll reach out to this number within 24 hrs