Vision Stability and Preference for Soft Toric vs. Soft Spherical Contact Lenses

NCT ID: NCT04536571

Last Updated: 2021-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-03
• Study Completion Date: 2021-06-07

Brief Summary

The principal hypothesis is to be tested in this work is that vision stability (the primary outcome measure) with a spherical contact lens correction vs. a toric contact lens correction will be the same.

Detailed Description

This will be a randomised, subject-masked, crossover, bilateral non-dispensing study, controlled by cross-comparison. Thirty subjects will use each lens type at a single visit in random sequence.

Conditions

Astigmatism; Myopia

Study Design

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

Study Groups

Test Contact lens

Subjects will be randomized to wear test lenses for 30 minutes, and then cross-over to control lenses.

Group Type: EXPERIMENTAL

Test Contact lens

Intervention Type: DEVICE

Subjects will be randomized to wear test lenses for 30 minutes, and then cross-over to control lenses.

Control Contact lens

Intervention Type: DEVICE

Subjects will be randomized to wear control lenses for 30 minutes, and then cross-over to test lenses.

Control Contact lens

Subjects will be randomized to wear control lenses for 30 minutes, and then cross-over to test lenses.

Group Type: ACTIVE_COMPARATOR

Test Contact lens

Intervention Type: DEVICE

Subjects will be randomized to wear test lenses for 30 minutes, and then cross-over to control lenses.

Control Contact lens

Intervention Type: DEVICE

Subjects will be randomized to wear control lenses for 30 minutes, and then cross-over to test lenses.

Interventions

Test Contact lens

Subjects will be randomized to wear test lenses for 30 minutes, and then cross-over to control lenses.

Intervention Type: DEVICE

Control Contact lens

Subjects will be randomized to wear control lenses for 30 minutes, and then cross-over to test lenses.

Intervention Type: DEVICE

Other Intervention Names

Soft comfilcon A toric contact lenses; Soft comfilcon A sphere contact lenses

Eligibility Criteria

Inclusion Criteria

1. They are aged 18-35 years and have capacity to volunteer.

2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.

3. They are willing and able to follow the protocol.

4. They are an existing wearer of soft spherical contact lenses in both eyes.

5. They have a spherical component of their spectacle refractive error between

-0.50DS and -6.50DS in both eyes.

6. They have a cylindrical component of their spectacle refractive error between

-0.75DC and -1.25DC in both eyes.

7. They can be fitted satisfactorily with both lens types.

8. They own an acceptable pair of spectacles.

9. They agree not to participate in other clinical research for the duration of the study.

Exclusion Criteria

1. They have an ocular disorder which would normally contra-indicate contact lens wear.

2. They have a systemic disorder which would normally contra-indicate contact lens wear.

3. They are using any topical medication such as eye drops (including comfort drops) or ointment on a regular basis.

4. They are aphakic.

5. They have had corneal refractive surgery.

6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.

7. They are pregnant or breastfeeding.

8. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.

9. They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.

10. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip Morgan, PhD.

Role: PRINCIPAL_INVESTIGATOR

University of Manchester

Locations

Eurolens Research

Manchester, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

C19-679 (EX-MKTG-115)

Identifier Type: -

Identifier Source: org_study_id