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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ametropia

Intervention / Treatment
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* Device: comfilcon A asphere
* Device: Spectacles


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: comfilcon A asphere<br>Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. | Device: comfilcon A asphere<br>* Contact Lens<br>* Other names: test;|
| Active Comparator: Habitual Spectacles<br>Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. | Device: Spectacles<br>* Habitual spectacles<br>* Other names: Single Vision Spectacles;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline | 
| 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). | 1 month | 
| 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). | 2 months | 
| 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). | Baseline | 
| 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). | One Month | 
| 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). | Two Months | 
| 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). | Baseline | 
| 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). | One Month | 
| 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). | Two Months | 
| 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). | Baseline | 
| 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). | One Month | 
| 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). | Two Months | 
| 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). | Baseline | 
| 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). | One Month | 
| 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). | Two Months | 
| 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). | Baseline | 
| 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). | One Month | 
| 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). | Two Months | 
| 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). | Baseline | 
| 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). | One Month | 
| 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). | Two Months | 
| 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). | Baseline | 
| 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). | One Month | 
| 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). | Two Months | 
| 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). | Baseline | 
| 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). | One Month | 
| 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). | Two Months | 
| 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). | Baseline | 
| 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). | One Month | 
| 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). | Two Months | 
| 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). | Baseline | 
| 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). | One Month | 
| 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). | Two Months | 
| 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). | Baseline | 
| 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). | One Month | 
| 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). | Two Months | 
| 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). | Baseline | 
| 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). | One Month | 
| 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). | Two Months | 
| 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). | Baseline | 
| 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). | One Month | 
| 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). | Two Months | 
| 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). | Baseline | 
| 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). | One Month | 
| 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). | Two Months | 
| 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). | Baseline | 
| 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). | One Month | 
| 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). | Two Months |