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

NCT04195581 | Completed Results FDA Device

• 1 other identifier: C19-658 EX-MKTG-108
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (3)

• Overall Comfort

  Overall Comfort will be assessed using vertical visual analogue scales (0-100) (0 - Causes Pain. Cannot be tolerated, 20 -Very uncomfortable, very irritating or annoying, 40 - Slightly uncomfortable, just irritating or annoying, 60 - Comfortable. Noticeable but not irritating, 80 - Very comfortable. Just felt occasionally, 100 - Excellent. Cannot be felt).

  One Month

• Comfort on Insertion

  Comfort on insertion will be assessed using vertical visual analogue scales (0-100) (0 - Causes Pain. Cannot be tolerated, 20 -Very uncomfortable, very irritating or annoying, 40 - Slightly uncomfortable, just irritating or annoying, 60 - Comfortable. Noticeable but not irritating, 80 - Very comfortable. Just felt occasionally, 100 - Excellent. Cannot be felt).

  One Month

• Comfort Before Removal

  Comfort before removal will be assessed using vertical visual analogue scales (0-100) (0 - Causes Pain. Cannot be tolerated, 20 -Very uncomfortable, very irritating or annoying, 40 - Slightly uncomfortable, just irritating or annoying, 60 - Comfortable. Noticeable but not irritating, 80 - Very comfortable. Just felt occasionally, 100 - Excellent. Cannot be felt).

  One Month

Secondary Outcomes (8)

• Vision

  One Month

• Variable Vision

  One Month

• Vision at Night

  One Month

• Dryness

  One Month

• Ocular Redness

  One Month

Study Arms (6)

comfilcon A with Hy-Care Multi-purpose solution

EXPERIMENTAL

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

Device: comfilcon A

comfilcon A with All in One Light Multi-purpose solution

EXPERIMENTAL

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

Device: comfilcon A

comfilcon A with Refine One Step Hydrogen Peroxide Solution

EXPERIMENTAL

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

Device: comfilcon A

fanfilcon A with Hy-Care Multi-purpose solution

ACTIVE COMPARATOR

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

Device: fanfilcon A

fanfilcon A with All in One Light multi-purpose solution

ACTIVE COMPARATOR

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

Device: fanfilcon A

fanfilcon A with Refine One Step Hydrogen Peroxide Solution

ACTIVE COMPARATOR

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

Device: fanfilcon A

Interventions

comfilcon A DEVICE

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

comfilcon A with All in One Light Multi-purpose solution; comfilcon A with Hy-Care Multi-purpose solution; comfilcon A with Refine One Step Hydrogen Peroxide Solution

fanfilcon A DEVICE

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

fanfilcon A with All in One Light multi-purpose solution; fanfilcon A with Hy-Care Multi-purpose solution; fanfilcon A with Refine One Step Hydrogen Peroxide Solution

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• They are aged 18-50 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 are an existing wearer of reusable, single vision, spherical soft contact lenses.
• They have a contact lens spherical prescription between -1.00 to - 6.50D (inclusive)
• They have a spectacle cylindrical correction of -1.00D or less in each eye.
• 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.
• They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
• They agree not to participate in other clinical research for the duration of the study.

You may not qualify if:

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

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

The University of Manchester

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Jose Vega, OD, MSc, FAAO
• Organization: CooperVision, Inc

JVega2@coopervision.com

925-621-3761

Study Officials

• Philip Morgan, MCOptom FAAO FBCLA

  Eurolens Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will use each lens and solution combination for a month in random sequence for a total of six months.

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 12, 2019
• Study Start: September 16, 2019
• Primary Completion: May 7, 2020
• Study Completion: May 7, 2020
• Last Updated: June 11, 2021
• Results First Posted: June 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)