A Clinical Evaluation of Two Contact Lenses Used With Three Care Systems

NCT ID: NCT04195581

Last Updated: 2021-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-16
• Study Completion Date: 2020-05-07

Brief Summary

The objective of the study was to compare the clinical performance of the two contact lenses when used in combination with three care systems.

Detailed Description

This was a randomized, open-label, crossover study, controlled by cross-comparison. Subjects were randomized to wear each lens and solution combination for a month in random sequence; that is for a total of six months.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

comfilcon A with Hy-Care Multi-purpose solution

Subjects were randomized to wear each lens and solution combination for a month.

Group Type: EXPERIMENTAL

comfilcon A

Intervention Type: DEVICE

Subjects were randomized to wear each lens and solution combination for a month.

comfilcon A with All in One Light Multi-purpose solution

Subjects were randomized to wear each lens and solution combination for a month.

Group Type: EXPERIMENTAL

comfilcon A

Intervention Type: DEVICE

Subjects were randomized to wear each lens and solution combination for a month.

comfilcon A with Refine One Step Hydrogen Peroxide Solution

Subjects were randomized to wear each lens and solution combination for a month.

Group Type: EXPERIMENTAL

comfilcon A

Intervention Type: DEVICE

Subjects were randomized to wear each lens and solution combination for a month.

fanfilcon A with Hy-Care Multi-purpose solution

Subjects were randomized to wear each lens and solution combination for a month.

Group Type: ACTIVE_COMPARATOR

fanfilcon A

Intervention Type: DEVICE

Subjects were randomized to wear each lens and solution combination for a month.

fanfilcon A with All in One Light multi-purpose solution

Subjects were randomized to wear each lens and solution combination for a month.

Group Type: ACTIVE_COMPARATOR

fanfilcon A

Intervention Type: DEVICE

Subjects were randomized to wear each lens and solution combination for a month.

fanfilcon A with Refine One Step Hydrogen Peroxide Solution

Subjects were randomized to wear each lens and solution combination for a month.

Group Type: ACTIVE_COMPARATOR

fanfilcon A

Intervention Type: DEVICE

Subjects were randomized to wear each lens and solution combination for a month.

Interventions

comfilcon A

Subjects were randomized to wear each lens and solution combination for a month.

Intervention Type: DEVICE

fanfilcon A

Subjects were randomized to wear each lens and solution combination for a month.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. They are aged 18-50 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 reusable, single vision, spherical soft contact lenses.

5. They have a contact lens spherical prescription between -1.00 to - 6.50D (inclusive)

6. They have a spectacle cylindrical correction of -1.00D or less in each eye.

7. At dispensing, they can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.

8. They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).

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 or ointment.

4. They have had cataract surgery.

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: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip Morgan, MCOptom FAAO FBCLA

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

C19-658 EX-MKTG-108

Identifier Type: -

Identifier Source: org_study_id