AmetropiaNCT04067050
A Clinical Study of the Comfilcon A Asphere Soft Contact Lens in Users of Digital Devices
A study testing comfilcon A asphere and Spectacles in people with Ametropia, run by CooperVision, Inc. at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Ametropia
- What is being tested?
- comfilcon A asphere and Spectacles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jul 2019to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Eurolens Research - The University of Manchester
Manchester, M13 9PL
About this study
Official title: A Clinical Study of the Biofinity Energys Soft Contact Lens in Users of Digital Devices
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.
Read the 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.
- Conditions
- Ametropia
- Being tested
- comfilcon A asphere, Spectacles
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comfilcon A asphereDevice
Also called test
Contact Lens
SpectaclesDevice
Also called Control, Single Vision Spectacles
Habitual spectacles
| Study group | Role | What they receive |
|---|---|---|
| comfilcon A asphere | Experimental | 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. Receives: Device: comfilcon A asphere |
| Habitual Spectacles | Active comparator | Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Receives: Device: Spectacles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Two Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start4 Jul 2019
- Primary completion28 Feb 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AmetropiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067050
- Sponsor's protocol ID
- EX-MKTG-105
- Status last verified
- Mar 2021
- First submitted
- 21 Aug 2019
- Last updated
- 13 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of the Biofinity Energys Soft Contact Lens in Users of Digital Devices
- ClinicalTrials.gov ID
- NCT04067050
- Acronym / sponsor ID
- EX-MKTG-105
- Conditions
- Ametropia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Jul 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 26 Aug 2019 (actual)
- Results
- Posted 13 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| comfilcon A asphere | Experimental | Device: comfilcon A asphereSubjects 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. |
| Habitual Spectacles | Active comparator | Device: SpectaclesSubjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comfilcon A asphereAlso: testContact Lens | Device | comfilcon A asphere |
| SpectaclesAlso: Control, Single Vision SpectaclesHabitual spectacles | Device | Habitual Spectacles |
Primary outcome
Symptom of Burning
Time frame: Baseline
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).
Symptom of Burning
Time frame: 1 month
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).
Symptom of Burning
Time frame: 2 months
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).
Symptom of Itching
Time frame: Baseline
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).
Symptom of Itching
Time frame: One Month
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).
Symptom of Itching
Time frame: Two Months
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).
Symptom of Feeling of Foreign Body
Time frame: Baseline
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).
Symptom of Feeling of Foreign Body
Time frame: One Month
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).
Symptom of Feeling of Foreign Body
Time frame: Two Months
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).
Symptom of Tearing
Time frame: Baseline
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).
Symptom of Tearing
Time frame: One Month
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).
Symptom of Tearing
Time frame: Two Months
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).
Symptom of Excessive Blinking
Time frame: Baseline
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).
Symptom of Excessive Blinking
Time frame: One Month
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).
Symptom of Excessive Blinking
Time frame: Two Months
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).
Symptom of Eye Redness
Time frame: Baseline
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).
Symptom of Eye Redness
Time frame: One Month
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).
Symptom of Eye Redness
Time frame: Two Months
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).
Symptom of Eye Pain
Time frame: Baseline
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).
Symptom of Eye Pain
Time frame: One Month
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).
Symptom of Eye Pain
Time frame: Two Months
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).
Symptom of Heavy Eyelids
Time frame: Baseline
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).
Symptom of Heavy Eyelids
Time frame: One Month
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).
Symptom of Heavy Eyelids
Time frame: Two Months
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).
Symptom of Dryness
Time frame: Baseline
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).
Symptom of Dryness
Time frame: One Month
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).
Symptom of Dryness
Time frame: Two Months
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).
Symptom of Blurred Vision
Time frame: Baseline
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).
Symptom of Blurred Vision
Time frame: One Month
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).
Symptom of Blurred Vision
Time frame: Two Months
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).
Symptom of Double Vision
Time frame: Baseline
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).
Symptom of Double Vision
Time frame: One Month
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).
Symptom of Double Vision
Time frame: Two Months
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).
Symptom of Difficulty Focusing For Near Vision
Time frame: Baseline
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).
Symptom of Difficulty Focusing For Near Vision
Time frame: One Month
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).
Symptom of Difficulty Focusing For Near Vision
Time frame: Two Months
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).
Symptom of Increased Sensitivity to Light
Time frame: Baseline
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).
Symptom of Increased Sensitivity to Light
Time frame: One Month
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).
Symptom of Increased Sensitivity to Light
Time frame: Two Months
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).
Symptom of Colored Haloes Around Objects
Time frame: Baseline
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).
Symptom of Colored Haloes Around Objects
Time frame: One Month
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).
Symptom of Colored Halos Around Objects
Time frame: Two Months
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).
Symptom of Feeling That Sight is Worsening
Time frame: Baseline
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).
Symptom of Feeling That Sight is Worsening
Time frame: One Month
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).
Symptom of Feeling That Sight is Worsening
Time frame: Two Months
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).
Symptom of Headache
Time frame: Baseline
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).
Symptom of Headache
Time frame: One Month
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).
Symptom of Headache
Time frame: Two Months
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing comfilcon A asphere and Spectacles in people with Ametropia, run by CooperVision, Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom of Burning (time frame: Baseline). The study lists 48 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.