Clinical trial NCT04067050: A Clinical Study of the Comfilcon A Asphere Soft Contact Lens in Users of Digital Devices
Official title: A Clinical Study of the Biofinity Energys Soft Contact Lens in Users of Digital Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ametropia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2019-08-26
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Symptom of Burning
timeFrame: Baseline
measure: Symptom of Burning
timeFrame: 1 month
measure: Symptom of Burning
timeFrame: 2 months
measure: Symptom of Itching
timeFrame: Baseline
measure: Symptom of Itching
timeFrame: One Month
measure: Symptom of Itching
timeFrame: Two Months
measure: Symptom of Feeling of Foreign Body
timeFrame: Baseline
measure: Symptom of Feeling of Foreign Body
timeFrame: One Month
measure: Symptom of Feeling of Foreign Body
timeFrame: Two Months
measure: Symptom of Tearing
timeFrame: Baseline
measure: Symptom of Tearing
timeFrame: One Month
measure: Symptom of Tearing
timeFrame: Two Months
measure: Symptom of Excessive Blinking
timeFrame: Baseline
measure: Symptom of Excessive Blinking
timeFrame: One Month
measure: Symptom of Excessive Blinking
timeFrame: Two Months
measure: Symptom of Eye Redness
timeFrame: Baseline
measure: Symptom of Eye Redness
timeFrame: One Month
measure: Symptom of Eye Redness
timeFrame: Two Months
measure: Symptom of Eye Pain
timeFrame: Baseline
measure: Symptom of Eye Pain
timeFrame: One Month
measure: Symptom of Eye Pain
timeFrame: Two Months
measure: Symptom of Heavy Eyelids
timeFrame: Baseline
measure: Symptom of Heavy Eyelids
timeFrame: One Month
measure: Symptom of Heavy Eyelids
timeFrame: Two Months
measure: Symptom of Dryness
timeFrame: Baseline
measure: Symptom of Dryness
timeFrame: One Month
measure: Symptom of Dryness
timeFrame: Two Months
measure: Symptom of Blurred Vision
timeFrame: Baseline
measure: Symptom of Blurred Vision
timeFrame: One Month
measure: Symptom of Blurred Vision
timeFrame: Two Months
measure: Symptom of Double Vision
timeFrame: Baseline
measure: Symptom of Double Vision
timeFrame: One Month
measure: Symptom of Double Vision
timeFrame: Two Months
measure: Symptom of Difficulty Focusing For Near Vision
timeFrame: Baseline
measure: Symptom of Difficulty Focusing For Near Vision
timeFrame: One Month
measure: Symptom of Difficulty Focusing For Near Vision
timeFrame: Two Months
measure: Symptom of Increased Sensitivity to Light
timeFrame: Baseline
measure: Symptom of Increased Sensitivity to Light
timeFrame: One Month
measure: Symptom of Increased Sensitivity to Light
timeFrame: Two Months
measure: Symptom of Colored Haloes Around Objects
timeFrame: Baseline
measure: Symptom of Colored Haloes Around Objects
timeFrame: One Month
measure: Symptom of Colored Halos Around Objects
timeFrame: Two Months
measure: Symptom of Feeling That Sight is Worsening
timeFrame: Baseline
measure: Symptom of Feeling That Sight is Worsening
timeFrame: One Month
measure: Symptom of Feeling That Sight is Worsening
timeFrame: Two Months
measure: Symptom of Headache
timeFrame: Baseline
measure: Symptom of Headache
timeFrame: One Month
measure: Symptom of Headache
timeFrame: Two Months
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Eurolens Research - The University of Manchester
Study officials:
References: