A Range of Contact Lenses and Care System Combinations

Launched by COOPERVISION, INC. · Aug 13, 2018

Keywords

ClinConnect Summary

Subjects were randomized to wear fanfilcon A soft contact lens in one eye and comfilcon A soft contact lens in the other eye with each lens having been soaked overnight in the Hy-Care contact lens solution and Lite contact lens solution.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. They are of legal age (18) and capacity to volunteer.
• • 2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
• • 3. They are willing and able to follow the protocol.
• • 4. They agree not to participate in other clinical research for the duration of this study.
• • 5. They can be satisfactorily fitted with the study lens for a period of approximately 2 hours.
• • 6. They can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with their habitual spectacles.
• • 7. They currently wear daily disposable soft contact lenses or have done so in the previous six months.
• • 8. They are willing to comply with the wear schedule (approximately 2 hours on two different days)
• • 9. They own a wearable pair of spectacles and agree to bring these to study visits.
• Exclusion Criteria:
• • 1. They have an ocular disorder which would normally contra-indicate contact lens wear.
• • 2. They have a systemic disorder which would normally contra-indicate contact lens wear.
• • 3. They currently wear reusable soft contact lenses in both eyes.
• • 4. They are using any topical medication such as eye drops or ointment.
• • 5. They have had cataract surgery.
• • 6. They have had corneal refractive surgery.
• • 7. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
• • 8. They are pregnant or breast-feeding.
• • 9. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
• • 10. They have Type 2 or greater corneal staining prior to lens application at Visit 1 or 2
• • 11. They have corneal staining covering greater than 20% in any corneal region at Visit 1a or 2a
• • 12. 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.
• • 13. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.