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A Clinical Study of the Comfilcon A Asphere Soft Contact Lens in Users of Digital Devices

A Clinical Study of the Biofinity Energys Soft Contact Lens in Users of Digital Devices

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04067050
Enrollment
61
Registered
2019-08-26
Start date
2019-07-04
Completion date
2020-03-30
Last updated
2021-04-13

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

Conditions

Ametropia

Brief summary

The aim of this work is to investigate the clinical performance and subjective acceptance of the comfilcon A asphere contact lens when compared to single-vision spectacles in subjects who have never worn contact lenses and who use digital devices (such as phones, tablets, laptops, desktop computers) for at least 4 hours per day on at least 5 days per week.

Detailed description

The aim of this clinical work is to compare the clinical performance and subjective acceptance of comfilcon A asphere contact lens when compared to single-vision spectacles in subjects who use digital devices (phones, tablets, laptops, desktop computers) for at least 4 hours per day on at least 5 days per week. Subjects will be randomized to use either their habitual spectacles or the study contact lenses for two months.

Interventions

DEVICEcomfilcon A asphere

Contact Lens

DEVICESpectacles

Habitual spectacles

Sponsors

CooperVision, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* They are between 18 and 35 years of age (inclusive). * 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 a 'neophyte' (i.e. someone who has not worn contact lenses previously, with the exception for the purposes of a trial fitting, lasting up to one week). * They have a contact lens spherical prescription between -1.00 to -6.25D (inclusive) based on the ocular refraction. * They have a cylindrical correction of -0.875DC or less in each eye based on the ocular refraction * They own and habitually wear single vision spectacles used for both distance and near vision, including computer and digital device use. * Their single vision spectacles have a mean sphere equivalent within ±0.50D of that of the refraction found in the study for each eye (after having taken lens effectivity into account). * They are willing to be fitted with contact lenses and understand they may be randomized to either group. * They are willing to wear the contact lenses (if relevant) or spectacles for at least 8 hours per day, 5 days per week. * They typically use digital devices for a minimum of 4 hours per day, 5 days per week. * They agree not to change the spectacles they will wear for digital device use for the duration of the study. * They agree not to participate in other clinical research for the duration of the study.

Exclusion criteria

* 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 (including comfort drops) or ointment on a regular basis. * The spectacles they use for digital device viewing on the study have been made with specialist features for computer use, digital eye fatigue or are multifocal/bifocal. * They are aphakic. * 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 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 evidence of a heterotropia or decompensating heterotropia on cover test. * They have a history of having been prescribed prism in their spectacles (by self report). * 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
Symptom of Difficulty Focusing For Near VisionBaselineSymptom of difficulty focusing for near vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Symptom of BurningBaselineSymptom of burning measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Symptom of ItchingBaselineSymptom of itching measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Symptom of Feeling of Foreign BodyBaselineSymptom of feeling of foreign body measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Symptom of TearingBaselineSymptom of tearing measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Symptom of Excessive BlinkingBaselineSymptom of excessive blinking measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Symptom of Increased Sensitivity to LightBaselineSymptom of increased sensitivity to light measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Symptom of Eye RednessBaselineSymptom of eye redness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Symptom of Eye PainBaselineSymptom of eye pain measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Symptom of Heavy EyelidsBaselineSymptom of heavy eyelids measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Symptom of DrynessBaselineSymptom of dryness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Symptom of Blurred VisionBaselineSymptom of blurred vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Symptom of Double VisionBaselineSymptom of double vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Symptom of Colored Haloes Around ObjectsBaselineSymptom of colored haloes around objects measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Symptom of Colored Halos Around ObjectsTwo MonthsSymptom of colored halos around objects measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Symptom of Feeling That Sight is WorseningBaselineSymptom of feeling that sight is worsening measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Symptom of HeadacheBaselineSymptom of headache measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Countries

United Kingdom

Participant flow

Participants by arm

ArmCount
Comfilcon A Asphere
Subjects were randomized to use the study contact lenses for two months.
32
Habitual Spectacles
Subjects were randomized to wear habitual spectacles for two months.
29
Total61

Withdrawals & dropouts

PeriodReasonFG000FG001
One MonthLost to Follow-up40
Two MonthAdverse Event10
Two MonthLost to Follow-up10

Baseline characteristics

CharacteristicHabitual SpectaclesTotalComfilcon A Asphere
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
29 Participants61 Participants32 Participants
Age, Continuous22.9 years
STANDARD_DEVIATION 4.4
23.7 years
STANDARD_DEVIATION 4.2
24.4 years
STANDARD_DEVIATION 3.9
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United Kingdom
29 participants61 participants32 participants
Sex: Female, Male
Female
18 Participants38 Participants20 Participants
Sex: Female, Male
Male
11 Participants23 Participants12 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 320 / 29
other
Total, other adverse events
1 / 320 / 29
serious
Total, serious adverse events
0 / 320 / 29

Outcome results

Primary

Symptom of Blurred Vision

Symptom of blurred vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: Baseline

Population: Intensity of symptom of blurred vision was measured only for subjects who had frequency of symptom of blurred vision on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of Blurred VisionFrequency0.34 units on a scaleStandard Deviation 0.48
Comfilcon A AsphereSymptom of Blurred VisionIntensity1.00 units on a scaleStandard Deviation 0
Habitual SpectaclesSymptom of Blurred VisionFrequency0.45 units on a scaleStandard Deviation 0.51
Habitual SpectaclesSymptom of Blurred VisionIntensity1.00 units on a scaleStandard Deviation 0
Primary

Symptom of Blurred Vision

Symptom of blurred vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: One Month

Population: One subject score was not measured for Habitual spectacles group. Intensity of symptom of blurred vision was measured only for subjects who had frequency of symptom of blurred vision on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of Blurred VisionFrequency0.54 units on a scaleStandard Deviation 0.58
Comfilcon A AsphereSymptom of Blurred VisionIntensity1.00 units on a scaleStandard Deviation 0
Habitual SpectaclesSymptom of Blurred VisionFrequency0.25 units on a scaleStandard Deviation 0.44
Habitual SpectaclesSymptom of Blurred VisionIntensity1.14 units on a scaleStandard Deviation 0.38
Primary

Symptom of Blurred Vision

Symptom of blurred vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: Two Months

Population: Intensity of symptom of blurred vision was measured only for subjects who had frequency of symptom of blurred vision on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of Blurred VisionFrequency0.35 units on a scaleStandard Deviation 0.49
Comfilcon A AsphereSymptom of Blurred VisionIntensity1.00 units on a scaleStandard Deviation 0
Habitual SpectaclesSymptom of Blurred VisionFrequency0.28 units on a scaleStandard Deviation 0.45
Habitual SpectaclesSymptom of Blurred VisionIntensity1.00 units on a scaleStandard Deviation 0
Primary

Symptom of Burning

Symptom of burning measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: Baseline

Population: Intensity of symptom of burning was measured only for subjects who had frequency of symptom of burning on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of BurningFrequency0.16 units on a scaleStandard Deviation 0.37
Comfilcon A AsphereSymptom of BurningIntensity1.00 units on a scaleStandard Deviation 0
Habitual SpectaclesSymptom of BurningFrequency0.21 units on a scaleStandard Deviation 0.49
Habitual SpectaclesSymptom of BurningIntensity1.00 units on a scaleStandard Deviation 0
Primary

Symptom of Burning

Symptom of burning measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: 1 month

Population: One subject scores was not measured for Habitual spectacles group. Intensity of symptom of burning was measured only for subjects who had frequency of symptom of burning on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of BurningFrequency0.11 units on a scaleStandard Deviation 0.31
Comfilcon A AsphereSymptom of BurningIntensity1.00 units on a scaleStandard Deviation 0
Habitual SpectaclesSymptom of BurningFrequency0.29 units on a scaleStandard Deviation 0.53
Habitual SpectaclesSymptom of BurningIntensity1.14 units on a scaleStandard Deviation 0.38
Primary

Symptom of Burning

Symptom of burning measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: 2 months

Population: Intensity of symptom of burning was measured only for subjects who had frequency of symptom of burning on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of BurningFrequency0.00 units on a scaleStandard Deviation 0
Habitual SpectaclesSymptom of BurningFrequency0.17 units on a scaleStandard Deviation 0.38
Habitual SpectaclesSymptom of BurningIntensity1.00 units on a scaleStandard Deviation 0
Primary

Symptom of Colored Haloes Around Objects

Symptom of colored haloes around objects measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: One Month

Population: One subject score was not measured for Habitual spectacles group. Intensity of symptom of colored haloes around objects was measured only for subjects who had frequency of symptom of colored haloes around objects on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of Colored Haloes Around ObjectsFrequency0.11 units on a scaleStandard Deviation 0.31
Comfilcon A AsphereSymptom of Colored Haloes Around ObjectsIntensity1.00 units on a scaleStandard Deviation 0
Habitual SpectaclesSymptom of Colored Haloes Around ObjectsFrequency0.07 units on a scaleStandard Deviation 0.26
Habitual SpectaclesSymptom of Colored Haloes Around ObjectsIntensity1.00 units on a scaleStandard Deviation 0
Primary

Symptom of Colored Haloes Around Objects

Symptom of colored haloes around objects measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: Baseline

Population: Intensity of symptom of colored haloes around objects was measured only for subjects who had frequency of symptom of colored haloes around objects on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of Colored Haloes Around ObjectsFrequency0.16 units on a scaleStandard Deviation 0.45
Comfilcon A AsphereSymptom of Colored Haloes Around ObjectsIntensity1.25 units on a scaleStandard Deviation 0.5
Habitual SpectaclesSymptom of Colored Haloes Around ObjectsFrequency0.17 units on a scaleStandard Deviation 0.47
Habitual SpectaclesSymptom of Colored Haloes Around ObjectsIntensity1.00 units on a scaleStandard Deviation 0
Primary

Symptom of Colored Halos Around Objects

Symptom of colored halos around objects measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: Two Months

Population: Intensity of symptom of colored haloes around objects was measured only for subjects who had frequency of symptom of colored haloes around objects on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of Colored Halos Around ObjectsFrequency0.10 units on a scaleStandard Deviation 0.31
Comfilcon A AsphereSymptom of Colored Halos Around ObjectsIntensity1.00 units on a scaleStandard Deviation 0
Habitual SpectaclesSymptom of Colored Halos Around ObjectsFrequency0.07 units on a scaleStandard Deviation 0.26
Habitual SpectaclesSymptom of Colored Halos Around ObjectsIntensity1.00 units on a scaleStandard Deviation 0
Primary

Symptom of Difficulty Focusing For Near Vision

Symptom of difficulty focusing for near vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: Two Months

Population: Intensity of symptom of difficulty focusing for near vision was measured only for subjects who had frequency of symptom of difficulty focusing for near vision on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of Difficulty Focusing For Near VisionFrequency0.45 units on a scaleStandard Deviation 0.51
Comfilcon A AsphereSymptom of Difficulty Focusing For Near VisionIntensity1.00 units on a scaleStandard Deviation 0
Habitual SpectaclesSymptom of Difficulty Focusing For Near VisionFrequency0.14 units on a scaleStandard Deviation 0.35
Habitual SpectaclesSymptom of Difficulty Focusing For Near VisionIntensity1.00 units on a scaleStandard Deviation 0
Primary

Symptom of Difficulty Focusing For Near Vision

Symptom of difficulty focusing for near vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: One Month

Population: One subject score was not measured for Habitual spectacles group. Intensity of symptom of difficulty focusing for near vision was measured only for subjects who had frequency of symptom of difficulty focusing for near vision on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of Difficulty Focusing For Near VisionFrequency0.18 units on a scaleStandard Deviation 0.39
Comfilcon A AsphereSymptom of Difficulty Focusing For Near VisionIntensity1.00 units on a scaleStandard Deviation 0
Habitual SpectaclesSymptom of Difficulty Focusing For Near VisionFrequency0.29 units on a scaleStandard Deviation 0.46
Habitual SpectaclesSymptom of Difficulty Focusing For Near VisionIntensity1.00 units on a scaleStandard Deviation 0
Primary

Symptom of Difficulty Focusing For Near Vision

Symptom of difficulty focusing for near vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: Baseline

Population: Intensity of symptom of difficulty focusing for near vision was measured only for subjects who had frequency of symptom of difficulty focusing for near vision on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of Difficulty Focusing For Near VisionFrequency0.28 units on a scaleStandard Deviation 0.46
Comfilcon A AsphereSymptom of Difficulty Focusing For Near VisionIntensity1.10 units on a scaleStandard Deviation 0.32
Habitual SpectaclesSymptom of Difficulty Focusing For Near VisionFrequency0.41 units on a scaleStandard Deviation 0.57
Habitual SpectaclesSymptom of Difficulty Focusing For Near VisionIntensity1.00 units on a scaleStandard Deviation 0
Primary

Symptom of Double Vision

Symptom of double vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: Baseline

Population: Intensity of symptom of double vision was measured only for subjects who had frequency of symptom of double vision on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of Double VisionFrequency0.06 units on a scaleStandard Deviation 0.25
Comfilcon A AsphereSymptom of Double VisionIntensity1.00 units on a scaleStandard Deviation 0
Habitual SpectaclesSymptom of Double VisionFrequency0.07 units on a scaleStandard Deviation 0.37
Habitual SpectaclesSymptom of Double VisionIntensity1.00 units on a scaleStandard Deviation 0
Primary

Symptom of Double Vision

Symptom of double vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: One Month

Population: One subject score was not measured for Habitual spectacles group. Intensity of symptom of double vision was measured only for subjects who had frequency of symptom of double vision on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of Double VisionFrequency0.11 units on a scaleStandard Deviation 0.31
Comfilcon A AsphereSymptom of Double VisionIntensity1.00 units on a scaleStandard Deviation 0
Habitual SpectaclesSymptom of Double VisionFrequency0.07 units on a scaleStandard Deviation 0.26
Habitual SpectaclesSymptom of Double VisionIntensity1.00 units on a scaleStandard Deviation 0
Primary

Symptom of Double Vision

Symptom of double vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: Two Months

Population: Intensity of symptom of double vision was measured only for subjects who had frequency of symptom of double vision on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of Double VisionFrequency0.05 units on a scaleStandard Deviation 0.22
Comfilcon A AsphereSymptom of Double VisionIntensity1.00 units on a scaleStandard Deviation 0
Habitual SpectaclesSymptom of Double VisionFrequency0.07 units on a scaleStandard Deviation 0.26
Habitual SpectaclesSymptom of Double VisionIntensity1.00 units on a scaleStandard Deviation 0
Primary

Symptom of Dryness

Symptom of dryness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: Baseline

Population: Intensity of symptom of dryness was measured only for subjects who had frequency of symptom of dryness on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of DrynessFrequency0.38 units on a scaleStandard Deviation 0.55
Comfilcon A AsphereSymptom of DrynessIntensity1.18 units on a scaleStandard Deviation 0.4
Habitual SpectaclesSymptom of DrynessFrequency0.48 units on a scaleStandard Deviation 0.51
Habitual SpectaclesSymptom of DrynessIntensity1.00 units on a scaleStandard Deviation 0
Primary

Symptom of Dryness

Symptom of dryness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: One Month

Population: One subject score was not measured for Habitual spectacles group. Intensity of symptom of dryness was measured only for subjects who had frequency of symptom of dryness on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of DrynessFrequency0.75 units on a scaleStandard Deviation 0.7
Comfilcon A AsphereSymptom of DrynessIntensity1.06 units on a scaleStandard Deviation 0.24
Habitual SpectaclesSymptom of DrynessFrequency0.43 units on a scaleStandard Deviation 0.5
Habitual SpectaclesSymptom of DrynessIntensity1.00 units on a scaleStandard Deviation 0
Primary

Symptom of Dryness

Symptom of dryness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: Two Months

Population: Intensity of symptom of dryness was measured only for subjects who had frequency of symptom of dryness on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of DrynessFrequency0.75 units on a scaleStandard Deviation 0.55
Comfilcon A AsphereSymptom of DrynessIntensity1.07 units on a scaleStandard Deviation 0.27
Habitual SpectaclesSymptom of DrynessFrequency0.48 units on a scaleStandard Deviation 0.57
Habitual SpectaclesSymptom of DrynessIntensity1.15 units on a scaleStandard Deviation 0.38
Primary

Symptom of Excessive Blinking

Symptom of excessive blinking measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: Two Months

Population: Intensity of symptom of excessive blinking was measured only for subjects who had frequency of symptom of excessive blinking on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of Excessive BlinkingFrequency0.35 units on a scaleStandard Deviation 0.49
Comfilcon A AsphereSymptom of Excessive BlinkingIntensity1.00 units on a scaleStandard Deviation 0
Habitual SpectaclesSymptom of Excessive BlinkingFrequency0.17 units on a scaleStandard Deviation 0.38
Habitual SpectaclesSymptom of Excessive BlinkingIntensity1.20 units on a scaleStandard Deviation 0.45
Primary

Symptom of Excessive Blinking

Symptom of excessive blinking measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: One Month

Population: One subject score was not measured for Habitual spectacles group. Intensity of symptom of excessive blinking was measured only for subjects who had frequency of symptom of excessive blinking on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of Excessive BlinkingFrequency0.46 units on a scaleStandard Deviation 0.51
Comfilcon A AsphereSymptom of Excessive BlinkingIntensity1.00 units on a scaleStandard Deviation 0
Habitual SpectaclesSymptom of Excessive BlinkingFrequency0.29 units on a scaleStandard Deviation 0.53
Habitual SpectaclesSymptom of Excessive BlinkingIntensity1.14 units on a scaleStandard Deviation 0.38
Primary

Symptom of Excessive Blinking

Symptom of excessive blinking measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: Baseline

Population: Intensity of symptom of excessive blinking was measured only for subjects who had frequency of symptom of excessive blinking on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of Excessive BlinkingIntensity1.00 units on a scaleStandard Deviation 0
Comfilcon A AsphereSymptom of Excessive BlinkingFrequency0.25 units on a scaleStandard Deviation 0.51
Habitual SpectaclesSymptom of Excessive BlinkingIntensity1.10 units on a scaleStandard Deviation 0.32
Habitual SpectaclesSymptom of Excessive BlinkingFrequency0.38 units on a scaleStandard Deviation 0.56
Primary

Symptom of Eye Pain

Symptom of eye pain measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: One Month

Population: One subject score was not measured for Habitual spectacles group. Intensity of symptom of eye pain was measured only for subjects who had frequency of symptom of eye pain on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of Eye PainFrequency0.14 units on a scaleStandard Deviation 0.36
Comfilcon A AsphereSymptom of Eye PainIntensity1.00 units on a scaleStandard Deviation 0
Habitual SpectaclesSymptom of Eye PainFrequency0.25 units on a scaleStandard Deviation 0.44
Habitual SpectaclesSymptom of Eye PainIntensity1.00 units on a scaleStandard Deviation 0
Primary

Symptom of Eye Pain

Symptom of eye pain measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: Two Months

Population: Intensity of symptom of eye pain was measured only for subjects who had frequency of symptom of eye pain on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of Eye PainFrequency0.00 units on a scaleStandard Deviation 0
Habitual SpectaclesSymptom of Eye PainIntensity1.00 units on a scaleStandard Deviation 0
Habitual SpectaclesSymptom of Eye PainFrequency0.31 units on a scaleStandard Deviation 0.54
Primary

Symptom of Eye Pain

Symptom of eye pain measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: Baseline

Population: Intensity of symptom of eye pain was measured only for subjects who had frequency of symptom of eye pain on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of Eye PainFrequency0.34 units on a scaleStandard Deviation 0.55
Comfilcon A AsphereSymptom of Eye PainIntensity1.10 units on a scaleStandard Deviation 0.32
Habitual SpectaclesSymptom of Eye PainFrequency0.34 units on a scaleStandard Deviation 0.61
Habitual SpectaclesSymptom of Eye PainIntensity1.13 units on a scaleStandard Deviation 0.35
Primary

Symptom of Eye Redness

Symptom of eye redness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: Two Months

Population: Intensity of symptom of eye redness was measured only for subjects who had frequency of symptom of eye redness on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of Eye RednessFrequency0.20 units on a scaleStandard Deviation 0.41
Comfilcon A AsphereSymptom of Eye RednessIntensity1.00 units on a scaleStandard Deviation 0
Habitual SpectaclesSymptom of Eye RednessFrequency0.24 units on a scaleStandard Deviation 0.44
Habitual SpectaclesSymptom of Eye RednessIntensity1.00 units on a scaleStandard Deviation 0
Primary

Symptom of Eye Redness

Symptom of eye redness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: Baseline

Population: Intensity of symptom of eye redness was measured only for subjects who had frequency of symptom of eye redness on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of Eye RednessFrequency0.28 units on a scaleStandard Deviation 0.46
Comfilcon A AsphereSymptom of Eye RednessIntensity1.11 units on a scaleStandard Deviation 0.33
Habitual SpectaclesSymptom of Eye RednessIntensity1.00 units on a scaleStandard Deviation 0
Habitual SpectaclesSymptom of Eye RednessFrequency0.21 units on a scaleStandard Deviation 0.41
Primary

Symptom of Eye Redness

Symptom of eye redness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: One Month

Population: One subject score was not measured for Habitual spectacles group. Intensity of symptom of eye redness was measured only for subjects who had frequency of symptom of eye redness on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of Eye RednessFrequency0.36 units on a scaleStandard Deviation 0.56
Comfilcon A AsphereSymptom of Eye RednessIntensity1.00 units on a scaleStandard Deviation 0
Habitual SpectaclesSymptom of Eye RednessFrequency0.18 units on a scaleStandard Deviation 0.39
Habitual SpectaclesSymptom of Eye RednessIntensity1.00 units on a scaleStandard Deviation 0
Primary

Symptom of Feeling of Foreign Body

Symptom of feeling of foreign body measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: One Month

Population: One subject score was not measured for Habitual spectacles group. Intensity of feeling of foreign body was measured only for subjects who had frequency of feeling of foreign body on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of Feeling of Foreign BodyFrequency0.75 units on a scaleStandard Deviation 0.59
Comfilcon A AsphereSymptom of Feeling of Foreign BodyIntensity1.00 units on a scaleStandard Deviation 0
Habitual SpectaclesSymptom of Feeling of Foreign BodyFrequency0.11 units on a scaleStandard Deviation 0.31
Habitual SpectaclesSymptom of Feeling of Foreign BodyIntensity1.00 units on a scaleStandard Deviation 0
Primary

Symptom of Feeling of Foreign Body

Symptom of feeling of foreign body measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: Baseline

Population: Intensity of feeling of foreign body was measured only for subjects who had frequency of feeling of foreign body on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of Feeling of Foreign BodyFrequency0.19 units on a scaleStandard Deviation 0.4
Comfilcon A AsphereSymptom of Feeling of Foreign BodyIntensity1.33 units on a scaleStandard Deviation 0.52
Habitual SpectaclesSymptom of Feeling of Foreign BodyFrequency0.17 units on a scaleStandard Deviation 0.38
Habitual SpectaclesSymptom of Feeling of Foreign BodyIntensity1.20 units on a scaleStandard Deviation 0.45
Primary

Symptom of Feeling of Foreign Body

Symptom of feeling of foreign body measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: Two Months

Population: Intensity of feeling of foreign body was measured only for subjects who had frequency of feeling of foreign body on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of Feeling of Foreign BodyFrequency0.50 units on a scaleStandard Deviation 0.61
Comfilcon A AsphereSymptom of Feeling of Foreign BodyIntensity1.00 units on a scaleStandard Deviation 0
Habitual SpectaclesSymptom of Feeling of Foreign BodyFrequency0.21 units on a scaleStandard Deviation 0.41
Habitual SpectaclesSymptom of Feeling of Foreign BodyIntensity1.00 units on a scaleStandard Deviation 0
Primary

Symptom of Feeling That Sight is Worsening

Symptom of feeling that sight is worsening measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: Two Months

Population: Intensity of symptom of feeling that sight is worsening was measured only for subjects who had frequency of symptom of feeling that sight is worsening on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of Feeling That Sight is WorseningFrequency0.20 units on a scaleStandard Deviation 0.41
Comfilcon A AsphereSymptom of Feeling That Sight is WorseningIntensity1.00 units on a scaleStandard Deviation 0
Habitual SpectaclesSymptom of Feeling That Sight is WorseningFrequency0.45 units on a scaleStandard Deviation 0.63
Habitual SpectaclesSymptom of Feeling That Sight is WorseningIntensity1.00 units on a scaleStandard Deviation 0
Primary

Symptom of Feeling That Sight is Worsening

Symptom of feeling that sight is worsening measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: One Month

Population: One subject score was not measured for Habitual spectacles group. Intensity of symptom of feeling that sight is worsening was measured only for subjects who had frequency of symptom of feeling that sight is worsening on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of Feeling That Sight is WorseningFrequency0.25 units on a scaleStandard Deviation 0.44
Comfilcon A AsphereSymptom of Feeling That Sight is WorseningIntensity1.00 units on a scaleStandard Deviation 0
Habitual SpectaclesSymptom of Feeling That Sight is WorseningFrequency0.36 units on a scaleStandard Deviation 0.49
Habitual SpectaclesSymptom of Feeling That Sight is WorseningIntensity1.10 units on a scaleStandard Deviation 0.32
Primary

Symptom of Feeling That Sight is Worsening

Symptom of feeling that sight is worsening measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: Baseline

Population: Intensity of symptom of feeling that sight is worsening was measured only for subjects who had frequency of symptom of feeling that sight is worsening on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of Feeling That Sight is WorseningFrequency0.34 units on a scaleStandard Deviation 0.6
Comfilcon A AsphereSymptom of Feeling That Sight is WorseningIntensity1.00 units on a scaleStandard Deviation 0
Habitual SpectaclesSymptom of Feeling That Sight is WorseningFrequency0.48 units on a scaleStandard Deviation 0.51
Habitual SpectaclesSymptom of Feeling That Sight is WorseningIntensity1.07 units on a scaleStandard Deviation 0.27
Primary

Symptom of Headache

Symptom of headache measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: One Month

Population: One subject score was not measured for Habitual spectacles group. Intensity of symptom of headache was measured only for subjects who had frequency of symptom of headache on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of HeadacheFrequency0.33 units on a scaleStandard Deviation 0.48
Comfilcon A AsphereSymptom of HeadacheIntensity1.22 units on a scaleStandard Deviation 0.44
Habitual SpectaclesSymptom of HeadacheFrequency0.54 units on a scaleStandard Deviation 0.58
Habitual SpectaclesSymptom of HeadacheIntensity1.14 units on a scaleStandard Deviation 0.36
Primary

Symptom of Headache

Symptom of headache measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: Baseline

Population: Intensity of symptom of headache was measured only for subjects who had frequency of symptom of headache on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of HeadacheFrequency0.72 units on a scaleStandard Deviation 0.63
Comfilcon A AsphereSymptom of HeadacheIntensity1.10 units on a scaleStandard Deviation 0.3
Habitual SpectaclesSymptom of HeadacheFrequency0.69 units on a scaleStandard Deviation 0.6
Habitual SpectaclesSymptom of HeadacheIntensity1.06 units on a scaleStandard Deviation 0.24
Primary

Symptom of Headache

Symptom of headache measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: Two Months

Population: Intensity of symptom of headache was measured only for subjects who had frequency of symptom of headache on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of HeadacheFrequency0.30 units on a scaleStandard Deviation 0.47
Comfilcon A AsphereSymptom of Headachentensity1.00 units on a scaleStandard Deviation 0
Habitual SpectaclesSymptom of HeadacheFrequency0.55 units on a scaleStandard Deviation 0.51
Habitual SpectaclesSymptom of Headachentensity1.13 units on a scaleStandard Deviation 0.34
Primary

Symptom of Heavy Eyelids

Symptom of heavy eyelids measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: Baseline

Population: Intensity of symptom of heavy eyelids was measured only for subjects who had frequency of symptom of heavy eyelids on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of Heavy EyelidsFrequency0.56 units on a scaleStandard Deviation 0.62
Comfilcon A AsphereSymptom of Heavy EyelidsIntensity1.13 units on a scaleStandard Deviation 0.34
Habitual SpectaclesSymptom of Heavy EyelidsFrequency0.45 units on a scaleStandard Deviation 0.51
Habitual SpectaclesSymptom of Heavy EyelidsIntensity1.00 units on a scaleStandard Deviation 0
Primary

Symptom of Heavy Eyelids

Symptom of heavy eyelids measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: Two Months

Population: Intensity of symptom of heavy eyelids was measured only for subjects who had frequency of symptom of heavy eyelids on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of Heavy EyelidsFrequency0.35 units on a scaleStandard Deviation 0.49
Comfilcon A AsphereSymptom of Heavy EyelidsIntensity1.00 units on a scaleStandard Deviation 0
Habitual SpectaclesSymptom of Heavy EyelidsFrequency0.48 units on a scaleStandard Deviation 0.63
Habitual SpectaclesSymptom of Heavy EyelidsIntensity1.08 units on a scaleStandard Deviation 0.29
Primary

Symptom of Heavy Eyelids

Symptom of heavy eyelids measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: One Month

Population: One subject score was not measured for Habitual spectacles group. Intensity of symptom of heavy eyelids was measured only for subjects who had frequency of symptom of heavy eyelids on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of Heavy EyelidsFrequency0.39 units on a scaleStandard Deviation 0.5
Comfilcon A AsphereSymptom of Heavy EyelidsIntensity1.00 units on a scaleStandard Deviation 0
Habitual SpectaclesSymptom of Heavy EyelidsFrequency0.46 units on a scaleStandard Deviation 0.58
Habitual SpectaclesSymptom of Heavy EyelidsIntensity1.17 units on a scaleStandard Deviation 0.39
Primary

Symptom of Increased Sensitivity to Light

Symptom of increased sensitivity to light measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: Baseline

Population: Intensity of symptom of increased sensitivity to light was measured only for subjects who had frequency of symptom of increased sensitivity to light on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of Increased Sensitivity to LightFrequency0.59 units on a scaleStandard Deviation 0.67
Comfilcon A AsphereSymptom of Increased Sensitivity to LightIntensity1.19 units on a scaleStandard Deviation 0.4
Habitual SpectaclesSymptom of Increased Sensitivity to LightFrequency0.48 units on a scaleStandard Deviation 0.63
Habitual SpectaclesSymptom of Increased Sensitivity to LightIntensity1.17 units on a scaleStandard Deviation 0.39
Primary

Symptom of Increased Sensitivity to Light

Symptom of increased sensitivity to light measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: One Month

Population: One subject score was not measured for Habitual spectacles group. Intensity of symptom of increased sensitivity to light was measured only for subjects who had frequency of symptom of increased sensitivity to light on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of Increased Sensitivity to LightFrequency0.25 units on a scaleStandard Deviation 0.44
Comfilcon A AsphereSymptom of Increased Sensitivity to LightIntensity1.00 units on a scaleStandard Deviation 0
Habitual SpectaclesSymptom of Increased Sensitivity to LightFrequency0.36 units on a scaleStandard Deviation 0.62
Habitual SpectaclesSymptom of Increased Sensitivity to LightIntensity1.13 units on a scaleStandard Deviation 0.35
Primary

Symptom of Increased Sensitivity to Light

Symptom of increased sensitivity to light measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: Two Months

Population: Intensity of symptom of increased sensitivity to light was measured only for subjects who had frequency of symptom of increased sensitivity to light on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of Increased Sensitivity to LightFrequency0.10 units on a scaleStandard Deviation 0.31
Comfilcon A AsphereSymptom of Increased Sensitivity to LightIntensity1.00 units on a scaleStandard Deviation 0
Habitual SpectaclesSymptom of Increased Sensitivity to LightFrequency0.24 units on a scaleStandard Deviation 0.44
Habitual SpectaclesSymptom of Increased Sensitivity to LightIntensity1.14 units on a scaleStandard Deviation 0.38
Primary

Symptom of Itching

Symptom of itching measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: Two Months

Population: Intensity of itching was measured only for subjects who had frequency of itching on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of ItchingFrequency0.45 units on a scaleStandard Deviation 0.51
Comfilcon A AsphereSymptom of ItchingIntensity1.00 units on a scaleStandard Deviation 0
Habitual SpectaclesSymptom of ItchingFrequency0.41 units on a scaleStandard Deviation 0.5
Habitual SpectaclesSymptom of ItchingIntensity1.00 units on a scaleStandard Deviation 0
Primary

Symptom of Itching

Symptom of itching measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: One Month

Population: One subject score was not measured for Habitual spectacles group. Intensity of itching was measured only for subjects who had frequency of itching on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of ItchingFrequency0.68 units on a scaleStandard Deviation 0.55
Comfilcon A AsphereSymptom of ItchingIntensity1.00 units on a scaleStandard Deviation 0
Habitual SpectaclesSymptom of ItchingFrequency0.36 units on a scaleStandard Deviation 0.56
Habitual SpectaclesSymptom of ItchingIntensity1.00 units on a scaleStandard Deviation 0
Primary

Symptom of Itching

Symptom of itching measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: Baseline

Population: Intensity of itching was measured only for subjects who had frequency of itching on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of ItchingFrequency0.41 units on a scaleStandard Deviation 0.56
Comfilcon A AsphereSymptom of ItchingIntensity1.08 units on a scaleStandard Deviation 0.29
Habitual SpectaclesSymptom of ItchingFrequency0.52 units on a scaleStandard Deviation 0.57
Habitual SpectaclesSymptom of ItchingIntensity1.00 units on a scaleStandard Deviation 0
Primary

Symptom of Tearing

Symptom of tearing measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: Two Months

Population: Intensity of symptom of tearing was measured only for subjects who had frequency of symptom of tearing on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of TearingFrequency0.35 units on a scaleStandard Deviation 0.49
Comfilcon A AsphereSymptom of TearingIntensity1.00 units on a scaleStandard Deviation 0
Habitual SpectaclesSymptom of TearingFrequency0.45 units on a scaleStandard Deviation 0.57
Habitual SpectaclesSymptom of TearingIntensity1.08 units on a scaleStandard Deviation 0.29
Primary

Symptom of Tearing

Symptom of tearing measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: Baseline

Population: Intensity of symptom of tearing was measured only for subjects who had frequency of symptom of tearing on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of TearingFrequency0.53 units on a scaleStandard Deviation 0.51
Comfilcon A AsphereSymptom of TearingIntensity1.06 units on a scaleStandard Deviation 0.24
Habitual SpectaclesSymptom of TearingFrequency0.43 units on a scaleStandard Deviation 0.63
Habitual SpectaclesSymptom of TearingIntensity1.18 units on a scaleStandard Deviation 0.4
Primary

Symptom of Tearing

Symptom of tearing measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Time frame: One Month

Population: One subject score was not measured for Habitual spectacles group. Intensity of symptom of tearing was measured only for subjects who had frequency of symptom of tearing on a scale of 1 - occasionally and 2- often/always

ArmMeasureGroupValue (MEAN)Dispersion
Comfilcon A AsphereSymptom of TearingFrequency0.39 units on a scaleStandard Deviation 0.57
Comfilcon A AsphereSymptom of TearingIntensity1.00 units on a scaleStandard Deviation 0
Habitual SpectaclesSymptom of TearingFrequency0.33 units on a scaleStandard Deviation 0.48
Habitual SpectaclesSymptom of TearingIntensity1.10 units on a scaleStandard Deviation 0.32

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