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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04195581
Enrollment
33
Registered
2019-12-12
Start date
2019-09-16
Completion date
2020-05-07
Last updated
2021-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

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.

Interventions

DEVICEcomfilcon A

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

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

Sponsors

CooperVision, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Overall ComfortOne MonthOverall 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).
Comfort on InsertionOne MonthComfort 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).
Comfort Before RemovalOne MonthComfort 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).

Secondary

MeasureTime frameDescription
DrynessOne MonthDryness 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).
Ocular RednessOne MonthOcular 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).
VisionOne MonthVision 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)
Ease of Lens InsertionOne MonthEase 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).
Ease of Lens RemovalOne MonthEase 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).
Burning/StingingOne MonthBurning/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).
Variable VisionOne MonthVariable 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).
Vision at NightOne MonthVision 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)

Countries

United Kingdom

Participant flow

Participants by arm

ArmCount
Overall Study
Subjects were randomized to use each lens and solution combination for a month in random sequence; that is for a total of six months. Lenses (comfilcon A and fanfilcon A), Lens care solutions(Hy-Care, All in One Light and Refine One Step).
33
Total33

Withdrawals & dropouts

PeriodReasonFG000
Comfilcon A With All in One LightWithdrawal by Subject4
Comfilcon A With Hy-CareWithdrawal by Subject5
Comfilcon A With Refine One StepWithdrawal by Subject1
Fanfilcon A With All in One LightWithdrawal by Subject1
Fanfilcon A With Hy-CareWithdrawal by Subject3
Fanfilcon A With Refine One StepWithdrawal by Subject2

Baseline characteristics

CharacteristicOverall Study
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
33 Participants
Age, Continuous28.3 years
STANDARD_DEVIATION 7.4
Race and Ethnicity Not Collected— Participants
Region of Enrollment
United Kingdom
33 participants
Sex: Female, Male
Female
29 Participants
Sex: Female, Male
Male
4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
deaths
Total, all-cause mortality
0 / 300 / 280 / 250 / 280 / 280 / 29
other
Total, other adverse events
2 / 300 / 280 / 252 / 281 / 282 / 29
serious
Total, serious adverse events
1 / 300 / 280 / 250 / 281 / 280 / 29

Outcome results

Primary

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).

Time frame: One Month

ArmMeasureValue (MEAN)Dispersion
Comfilcon A With All in One Light Multi-purpose SolutionComfort Before Removal80.0 units on a scaleStandard Deviation 17.2
Comfilcon A With Hy-Care Multi-purpose SolutionComfort Before Removal72.8 units on a scaleStandard Deviation 17.8
Comfilcon A With Refine One Step Hydrogen Peroxide SolutionComfort Before Removal74.2 units on a scaleStandard Deviation 19.9
Fanfilcon A With All in One Light Multi-purpose SolutionComfort Before Removal79.1 units on a scaleStandard Deviation 17.2
Fanfilcon A With Hy-Care Multi-purpose SolutionComfort Before Removal82.4 units on a scaleStandard Deviation 14.2
Fanfilcon A With Refine One Step Hydrogen Peroxide SolutionComfort Before Removal76.1 units on a scaleStandard Deviation 19.9
Primary

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).

Time frame: One Month

ArmMeasureValue (MEAN)Dispersion
Comfilcon A With All in One Light Multi-purpose SolutionComfort on Insertion88.3 units on a scaleStandard Deviation 12.7
Comfilcon A With Hy-Care Multi-purpose SolutionComfort on Insertion85.8 units on a scaleStandard Deviation 15
Comfilcon A With Refine One Step Hydrogen Peroxide SolutionComfort on Insertion84.0 units on a scaleStandard Deviation 17.1
Fanfilcon A With All in One Light Multi-purpose SolutionComfort on Insertion88.6 units on a scaleStandard Deviation 14.9
Fanfilcon A With Hy-Care Multi-purpose SolutionComfort on Insertion90.3 units on a scaleStandard Deviation 10.6
Fanfilcon A With Refine One Step Hydrogen Peroxide SolutionComfort on Insertion87.3 units on a scaleStandard Deviation 11.8
Primary

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).

Time frame: One Month

ArmMeasureValue (MEAN)Dispersion
Comfilcon A With All in One Light Multi-purpose SolutionOverall Comfort86.0 units on a scaleStandard Deviation 12
Comfilcon A With Hy-Care Multi-purpose SolutionOverall Comfort81.6 units on a scaleStandard Deviation 14.9
Comfilcon A With Refine One Step Hydrogen Peroxide SolutionOverall Comfort81.0 units on a scaleStandard Deviation 17.1
Fanfilcon A With All in One Light Multi-purpose SolutionOverall Comfort87.7 units on a scaleStandard Deviation 11.7
Fanfilcon A With Hy-Care Multi-purpose SolutionOverall Comfort88.0 units on a scaleStandard Deviation 9.5
Fanfilcon A With Refine One Step Hydrogen Peroxide SolutionOverall Comfort82.7 units on a scaleStandard Deviation 16.7
Secondary

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).

Time frame: One Month

ArmMeasureValue (MEAN)Dispersion
Comfilcon A With All in One Light Multi-purpose SolutionBurning/Stinging93.4 units on a scaleStandard Deviation 13.1
Comfilcon A With Hy-Care Multi-purpose SolutionBurning/Stinging90.6 units on a scaleStandard Deviation 14.7
Comfilcon A With Refine One Step Hydrogen Peroxide SolutionBurning/Stinging85.7 units on a scaleStandard Deviation 16.4
Fanfilcon A With All in One Light Multi-purpose SolutionBurning/Stinging92.4 units on a scaleStandard Deviation 14.3
Fanfilcon A With Hy-Care Multi-purpose SolutionBurning/Stinging95.7 units on a scaleStandard Deviation 7.8
Fanfilcon A With Refine One Step Hydrogen Peroxide SolutionBurning/Stinging89.6 units on a scaleStandard Deviation 14.8
Secondary

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).

Time frame: One Month

ArmMeasureValue (MEAN)Dispersion
Comfilcon A With All in One Light Multi-purpose SolutionDryness85.5 units on a scaleStandard Deviation 18.2
Comfilcon A With Hy-Care Multi-purpose SolutionDryness81.4 units on a scaleStandard Deviation 17.4
Comfilcon A With Refine One Step Hydrogen Peroxide SolutionDryness81.5 units on a scaleStandard Deviation 20.5
Fanfilcon A With All in One Light Multi-purpose SolutionDryness86.6 units on a scaleStandard Deviation 11.3
Fanfilcon A With Hy-Care Multi-purpose SolutionDryness86.3 units on a scaleStandard Deviation 12.7
Fanfilcon A With Refine One Step Hydrogen Peroxide SolutionDryness83.3 units on a scaleStandard Deviation 16.3
Secondary

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).

Time frame: One Month

ArmMeasureValue (MEAN)Dispersion
Comfilcon A With All in One Light Multi-purpose SolutionEase of Lens Insertion93.5 units on a scaleStandard Deviation 9
Comfilcon A With Hy-Care Multi-purpose SolutionEase of Lens Insertion91.2 units on a scaleStandard Deviation 9.7
Comfilcon A With Refine One Step Hydrogen Peroxide SolutionEase of Lens Insertion91.7 units on a scaleStandard Deviation 12.4
Fanfilcon A With All in One Light Multi-purpose SolutionEase of Lens Insertion91.6 units on a scaleStandard Deviation 14.1
Fanfilcon A With Hy-Care Multi-purpose SolutionEase of Lens Insertion92.9 units on a scaleStandard Deviation 9.7
Fanfilcon A With Refine One Step Hydrogen Peroxide SolutionEase of Lens Insertion91.3 units on a scaleStandard Deviation 11.9
Secondary

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).

Time frame: One Month

ArmMeasureValue (MEAN)Dispersion
Comfilcon A With All in One Light Multi-purpose SolutionEase of Lens Removal92.1 units on a scaleStandard Deviation 13.7
Comfilcon A With Hy-Care Multi-purpose SolutionEase of Lens Removal92.2 units on a scaleStandard Deviation 12.6
Comfilcon A With Refine One Step Hydrogen Peroxide SolutionEase of Lens Removal91.6 units on a scaleStandard Deviation 14
Fanfilcon A With All in One Light Multi-purpose SolutionEase of Lens Removal90.9 units on a scaleStandard Deviation 10.7
Fanfilcon A With Hy-Care Multi-purpose SolutionEase of Lens Removal92.0 units on a scaleStandard Deviation 11.6
Fanfilcon A With Refine One Step Hydrogen Peroxide SolutionEase of Lens Removal89.7 units on a scaleStandard Deviation 12.5
Secondary

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).

Time frame: One Month

ArmMeasureValue (MEAN)Dispersion
Comfilcon A With All in One Light Multi-purpose SolutionOcular Redness96.2 units on a scaleStandard Deviation 8.6
Comfilcon A With Hy-Care Multi-purpose SolutionOcular Redness92.6 units on a scaleStandard Deviation 13.7
Comfilcon A With Refine One Step Hydrogen Peroxide SolutionOcular Redness94.2 units on a scaleStandard Deviation 10.9
Fanfilcon A With All in One Light Multi-purpose SolutionOcular Redness95.8 units on a scaleStandard Deviation 8.9
Fanfilcon A With Hy-Care Multi-purpose SolutionOcular Redness96.0 units on a scaleStandard Deviation 5.6
Fanfilcon A With Refine One Step Hydrogen Peroxide SolutionOcular Redness92.7 units on a scaleStandard Deviation 9.3
Secondary

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).

Time frame: One Month

Population: One subject was excluded from the analysis from fanfilcon A with All in One Light multipurpose solution and fanfilcon A with Refine One Step Hydrogen Peroxide Solution.

ArmMeasureValue (MEAN)Dispersion
Comfilcon A With All in One Light Multi-purpose SolutionVariable Vision92.5 units on a scaleStandard Deviation 9.5
Comfilcon A With Hy-Care Multi-purpose SolutionVariable Vision92.0 units on a scaleStandard Deviation 11.5
Comfilcon A With Refine One Step Hydrogen Peroxide SolutionVariable Vision91.8 units on a scaleStandard Deviation 13.2
Fanfilcon A With All in One Light Multi-purpose SolutionVariable Vision89.8 units on a scaleStandard Deviation 15.4
Fanfilcon A With Hy-Care Multi-purpose SolutionVariable Vision92.8 units on a scaleStandard Deviation 9.5
Fanfilcon A With Refine One Step Hydrogen Peroxide SolutionVariable Vision92.8 units on a scaleStandard Deviation 10.9
Secondary

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)

Time frame: One Month

Population: One subject was excluded from the analysis from fanfilcon A with All in One Light multipurpose solution and fanfilcon A with Refine One Step Hydrogen Peroxide Solution.

ArmMeasureValue (MEAN)Dispersion
Comfilcon A With All in One Light Multi-purpose SolutionVision94.8 units on a scaleStandard Deviation 7.7
Comfilcon A With Hy-Care Multi-purpose SolutionVision91.4 units on a scaleStandard Deviation 11.9
Comfilcon A With Refine One Step Hydrogen Peroxide SolutionVision93.3 units on a scaleStandard Deviation 9.3
Fanfilcon A With All in One Light Multi-purpose SolutionVision90.9 units on a scaleStandard Deviation 13.1
Fanfilcon A With Hy-Care Multi-purpose SolutionVision94.2 units on a scaleStandard Deviation 7.7
Fanfilcon A With Refine One Step Hydrogen Peroxide SolutionVision93.4 units on a scaleStandard Deviation 10.1
Secondary

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)

Time frame: One Month

Population: One subject was excluded from the analysis from fanfilcon A with All in One Light multipurpose solution and fanfilcon A with Refine One Step Hydrogen Peroxide Solution.

ArmMeasureValue (MEAN)Dispersion
Comfilcon A With All in One Light Multi-purpose SolutionVision at Night92.5 units on a scaleStandard Deviation 9.4
Comfilcon A With Hy-Care Multi-purpose SolutionVision at Night89.4 units on a scaleStandard Deviation 13.8
Comfilcon A With Refine One Step Hydrogen Peroxide SolutionVision at Night91.6 units on a scaleStandard Deviation 12.5
Fanfilcon A With All in One Light Multi-purpose SolutionVision at Night89.8 units on a scaleStandard Deviation 13
Fanfilcon A With Hy-Care Multi-purpose SolutionVision at Night91.3 units on a scaleStandard Deviation 9.2
Fanfilcon A With Refine One Step Hydrogen Peroxide SolutionVision at Night91.4 units on a scaleStandard Deviation 11

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026