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

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

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: comfilcon A; Device: fanfilcon A

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom
    • The University of Manchester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: comfilcon A with Hy-Care Multi-purpose solution; Subjects were randomized to wear each lens and solution combination for a month.	Device: comfilcon A; Subjects were randomized to wear each lens and solution combination for a month.
Experimental: comfilcon A with All in One Light Multi-purpose solution; Subjects were randomized to wear each lens and solution combination for a month.	Device: comfilcon A; Subjects were randomized to wear each lens and solution combination for a month.
Experimental: comfilcon A with Refine One Step Hydrogen Peroxide Solution; Subjects were randomized to wear each lens and solution combination for a month.	Device: comfilcon A; Subjects were randomized to wear each lens and solution combination for a month.
Active Comparator: fanfilcon A with Hy-Care Multi-purpose solution; Subjects were randomized to wear each lens and solution combination for a month.	Device: fanfilcon A; Subjects were randomized to wear each lens and solution combination for a month.
Active Comparator: fanfilcon A with All in One Light multi-purpose solution; Subjects were randomized to wear each lens and solution combination for a month.	Device: fanfilcon A; Subjects were randomized to wear each lens and solution combination for a month.
Active Comparator: fanfilcon A with Refine One Step Hydrogen Peroxide Solution; Subjects were randomized to wear each lens and solution combination for a month.	Device: fanfilcon A; Subjects were randomized to wear each lens and solution combination for a month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vision	Vision will be assessed using vertical visual analogue scales (0-100) (0 - Unacceptable. Lens cannot be worn, 20 - Very poor. Marked and unacceptable reduction, 40 - Poor. Noticeable but acceptable reduction, 60 - Good. Occasional but acceptable reduction, 80 - Very good. Just noticeable and very occasional reduction, 100 -Excellent. Unaware of any visual loss)	One Month
Variable Vision	Variable Vision will be assessed using vertical visual analogue scales (0-100) (0 - Extremely poor. Intolerable levels of variation in vision, 20 - Very poor. Excessive variation in vision which definitely affects wearing my contact lenses, 40 - Poor. A level of variation in vision which is sometimes annoying, Good. Acceptable level of variation in vision, 80 - Very good. Very occasional or very slight sensation of variation in vision, 100 - Excellent. No variation in vision).	One Month
Vision at Night	Vision at night will be assessed using vertical visual analogue scales (0-100) (0 - Unacceptable. Lens cannot be worn, 20 - Very poor. Marked and unacceptable reduction, 40 - Poor. Noticeable but acceptable reduction, 60 - Good. Occasional but acceptable reduction, 80 - Very good. Just noticeable and very occasional reduction, 100 -Excellent. Unaware of any visual loss)	One Month
Dryness	Dryness will be assessed using vertical visual analogue scales (0-100) (0 - Extremely poor. Intolerable levels of dryness, 20 - Very poor. Dryness which definitely affects wearing my contact lenses, 40 - Poor. A level of dryness which is sometimes annoying, 60 - Good. Acceptable level of dryness, 80 - Very good. Very occasional or very slight sensation of dryness only, 100 - Excellent. I have no sensation of dryness whatsoever).	One Month
Ocular Redness	Ocular Redness will be assessed using vertical visual analogue scales (0-100) (0 - Extremely poor. Intolerable levels of redness, 20 - Very poor. Excessive redness which definitely affects wearing my contact lenses, 40 - Poor. A level of redness which is sometimes annoying, 60 - Good. Acceptable level of redness, 80 - Very good. Very occasional or very slight awareness of redness, 100 - Excellent. No redness).	One Month
Burning/Stinging	Burning/Stinging will be assessed using vertical visual analogue scales (0-100) (0 - Extremely poor. Intolerable levels of burning or stinging, 20 - Very poor. Excessive burning or stinging which definitely affects wearing my contact lenses, 40 - Poor. A level of burning or stinging which is sometimes annoying, 60 - Good. Acceptable level of burning or stinging, 80 - Very good. Very occasional or very slight sensation of burning or stinging, 100 - Excellent. No burning or stinging).	One Month
Ease of Lens Insertion	Ease of lens insertion will be assessed using vertical visual analogue scales 0-100. (0 - Unmanageable. Lenses impossible to insert, 20 - Very poor. Difficult and occasional unsuccessful insertion, 40 - Poor. Difficult with very occasional unsuccessful insertion, 60 - Good. Some problems but lens insertion usually successful, 80 - Very good. Occasional difficulty with lens insertion, 100 - Excellent. No problems with lens insertion).	One Month
Ease of Lens Removal	Ease of lens removal will be assessed using vertical visual analogue scales (0-100) ( 0 - Unmanageable. Lenses impossible to remove, 20 - Very poor. Difficult and occasional unsuccessful removal, 40 - Poor. Difficult with very occasional unsuccessful removal, 60 - Good. Some problems but lens removal usually successful, 80 - Very good. Occasional difficulty with lens removal, 100 - Excellent. No problems with lens removal).	One Month

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Philip Morgan, MCOptom FAAO FBCLA, Eurolens Research

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2019
• Primary Completion (Actual): May 7, 2020
• Study Completion (Actual): May 7, 2020

Study Registration Dates

• First Submitted: December 10, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (Actual): December 12, 2019

Study Record Updates

• Last Update Posted (Actual): June 11, 2021
• Last Update Submitted That Met QC Criteria: May 18, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: C19-658 EX-MKTG-108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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