N/A N=61 Randomized Other

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

Ametropia

Bottom Line

View on ClinicalTrials.gov: NCT04067050 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2021

Primary outcome: Primary: Symptom of Burning — 0.16; 0.21; 1.00; 1.00 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: comfilcon A asphere (Device); Spectacles (Device)
Age: Adult · 18+ yrs
Sex: All
Sponsor: CooperVision, Inc.
Primary completion: Feb 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Symptom of Burning	0.00; 0.17; 1.00	—
PRIMARY Symptom of Burning	0.00; 0.17; 1.00	—
PRIMARY Symptom of Burning	0.00; 0.17; 1.00	—
PRIMARY Symptom of Itching	0.45; 0.41; 1.00; 1.00	—
PRIMARY Symptom of Itching	0.45; 0.41; 1.00; 1.00	—
PRIMARY Symptom of Itching	0.45; 0.41; 1.00; 1.00	—
PRIMARY Symptom of Feeling of Foreign Body	0.50; 0.21; 1.00; 1.00	—
PRIMARY Symptom of Feeling of Foreign Body	0.50; 0.21; 1.00; 1.00	—
PRIMARY Symptom of Feeling of Foreign Body	0.50; 0.21; 1.00; 1.00	—
PRIMARY Symptom of Tearing	0.35; 0.45; 1.00; 1.08	—
PRIMARY Symptom of Tearing	0.35; 0.45; 1.00; 1.08	—
PRIMARY Symptom of Tearing	0.35; 0.45; 1.00; 1.08	—
PRIMARY Symptom of Excessive Blinking	0.35; 0.17; 1.00; 1.20	—
PRIMARY Symptom of Excessive Blinking	0.35; 0.17; 1.00; 1.20	—
PRIMARY Symptom of Excessive Blinking	0.35; 0.17; 1.00; 1.20	—
PRIMARY Symptom of Eye Redness	0.20; 0.24; 1.00; 1.00	—
PRIMARY Symptom of Eye Redness	0.20; 0.24; 1.00; 1.00	—
PRIMARY Symptom of Eye Redness	0.20; 0.24; 1.00; 1.00	—
PRIMARY Symptom of Eye Pain	0.00; 0.31; 1.00	—
PRIMARY Symptom of Eye Pain	0.00; 0.31; 1.00	—
PRIMARY Symptom of Eye Pain	0.00; 0.31; 1.00	—
PRIMARY Symptom of Heavy Eyelids	0.35; 0.48; 1.00; 1.08	—
PRIMARY Symptom of Heavy Eyelids	0.35; 0.48; 1.00; 1.08	—
PRIMARY Symptom of Heavy Eyelids	0.35; 0.48; 1.00; 1.08	—
PRIMARY Symptom of Dryness	0.75; 0.48; 1.07; 1.15	—
PRIMARY Symptom of Dryness	0.75; 0.48; 1.07; 1.15	—
PRIMARY Symptom of Dryness	0.75; 0.48; 1.07; 1.15	—
PRIMARY Symptom of Blurred Vision	0.35; 0.28; 1.00; 1.00	—
PRIMARY Symptom of Blurred Vision	0.35; 0.28; 1.00; 1.00	—
PRIMARY Symptom of Blurred Vision	0.35; 0.28; 1.00; 1.00	—
PRIMARY Symptom of Double Vision	0.05; 0.07; 1.00; 1.00	—
PRIMARY Symptom of Double Vision	0.05; 0.07; 1.00; 1.00	—
PRIMARY Symptom of Double Vision	0.05; 0.07; 1.00; 1.00	—
PRIMARY Symptom of Difficulty Focusing For Near Vision	0.45; 0.14; 1.00; 1.00	—
PRIMARY Symptom of Difficulty Focusing For Near Vision	0.45; 0.14; 1.00; 1.00	—
PRIMARY Symptom of Difficulty Focusing For Near Vision	0.45; 0.14; 1.00; 1.00	—
PRIMARY Symptom of Increased Sensitivity to Light	0.10; 0.24; 1.00; 1.14	—
PRIMARY Symptom of Increased Sensitivity to Light	0.10; 0.24; 1.00; 1.14	—
PRIMARY Symptom of Increased Sensitivity to Light	0.10; 0.24; 1.00; 1.14	—
PRIMARY Symptom of Colored Haloes Around Objects	0.11; 0.07; 1.00; 1.00	—
PRIMARY Symptom of Colored Haloes Around Objects	0.11; 0.07; 1.00; 1.00	—
PRIMARY Symptom of Colored Halos Around Objects	0.10; 0.07; 1.00; 1.00	—
PRIMARY Symptom of Feeling That Sight is Worsening	0.20; 0.45; 1.00; 1.00	—
PRIMARY Symptom of Feeling That Sight is Worsening	0.20; 0.45; 1.00; 1.00	—
PRIMARY Symptom of Feeling That Sight is Worsening	0.20; 0.45; 1.00; 1.00	—
PRIMARY Symptom of Headache	0.30; 0.55; 1.00; 1.13	—
PRIMARY Symptom of Headache	0.30; 0.55; 1.00; 1.13	—
PRIMARY Symptom of Headache	0.30; 0.55; 1.00; 1.13	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04067050). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.