Clinical Evaluation of Two Silicone Hydrogel Contact Lenses

Launched by COOPERVISION, INC. · Apr 1, 2022

Keywords

ClinConnect Summary

This is a double-masked, randomized, bilateral crossover study to compare the short-term clinical performance of two silicone hydrogel soft contact lenses. Each lens type is worn for approximately six hours on separate study days, in random sequence.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. They are aged between 18 and 40 years.
• • 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 have successfully worn contact lenses within six months of starting the study.
• • 5. They can be satisfactorily fitted with the study contact lenses.
• • 6. They have a contact lens spherical prescription between -0.25 to - 6.00D (inclusive) based on the ocular refraction.
• • 7. They have a spectacle cylindrical correction of -0.75D or less in each eye based on the ocular refraction.
• • 8. They own and habitually wear single vision spectacles.
• • 9. They can attain at least 0.20 logMAR distance high contrast visual acuity in each eye, with the study lenses.
• • 10. They agree not to participate in other clinical research while enrolled on this study.
• Exclusion Criteria:
• • 1. They have an ocular disorder which would normally contraindicate contact lens wear.
• • 2. They have a systemic disorder which would normally contraindicate contact lens wear.
• • 3. They are using any topical medication such as eye drops or ointment.
• • 4. They are aphakic.
• • 5. They have had corneal refractive surgery.
• • 6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
• • 7. They are pregnant or breastfeeding.
• • 8. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (eg HIV) or a history of anaphylaxis or severe allergic reaction.
• • 9. They have grade 3 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality, which would normally contraindicate contact lens wear.
• • 10. They have taken part in any other clinical trial or research, within two weeks prior to starting this study, which may impact on this particular work.