Status:
COMPLETED
A Clinical Study of the Comfilcon A Asphere Soft Contact Lens in Users of Digital Devices
Lead Sponsor:
CooperVision, Inc.
Conditions:
Ametropia
Eligibility:
All Genders
18-35 years
Phase:
NA
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 w...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2020
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT04067050
Start Date
July 4 2019
End Date
March 30 2020
Last Update
April 13 2021
Active Locations (1)
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1
Eurolens Research - The University of Manchester
Manchester, United Kingdom, M13 9PL