Clinical Investigation of Buttermere (LENS 271) Soft Contact Lenses

Launched by COOPERVISION, INC. · Sep 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two types of soft contact lenses to see how well they work for people with myopia, which is a condition that makes it hard to see things far away. The trial is currently looking for participants, including children and teenagers aged 8 to 18, as well as adults up to 65 years old. To be eligible, participants should have some experience wearing soft contact lenses and be able to put them in and take them out on their own. They should also have good vision with their glasses, meaning they can see well enough to read the letters on an eye chart.

Participants in this trial will be asked to wear one of the two contact lenses being tested and follow specific instructions throughout the study. It's important for participants and their parents or guardians to read and understand the information provided about the trial before agreeing to take part. There are some health conditions that would exclude someone from participating, such as eye infections or certain eye diseases. Overall, this study aims to find out which contact lens option is better for managing myopia, helping to improve vision for those who need it.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • i. Age 8 to 18 years; at least half the population will be children or adolescents aged 8 to 15 years.
• • ii. Have experience with soft contact lens wear and able to insert and remove soft contact lenses.
• • iii. Parent/guardian and participant have read and understood the Participant Information Sheet.
• • iv. Parent/guardian and participant have read, signed and dated the Informed Consent and Assent (when applicable).
• • v. Best corrected visual acuity of at least 20/25 in each eye.
• • vi. Have normal eyes with the exception of the need for visual correction.
• vii. Spectacle refraction:
• • Age 8 to 12: -0.75D to -4.00D spherical equivalent, with cylinder ≤ -0.75D and maximum anisometropia of \<1.00D
• • Age 13-18: -0.75D to -7.00D spherical equivalent, with cylinder ≤ -0.75D and maximum anisometropia of \<1.00D.
• • viii. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule.
• Exclusion Criteria:
• • i. Acute and subacute inflammation or infection of the anterior chamber of the eye.
• • ii. Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids.
• • iii. Severe insufficiency of lacrimal secretion (dry eyes).
• • iv. Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic.
• • v. Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses.
• • vi. Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions.
• • vii. Any active corneal infection (bacterial, fungal, or viral).
• • viii. The patient is unable to follow lens handling and wear regimen or unable to obtain assistance to do so.
• • ix. Newly prescribed use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator.
• • x. Monocular participants (only one eye with functional vision) or participants fit with only one lens.
• • xi. Subjects with slit lamp findings greater than grade 1 (e.g., edema, infiltrates, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival, anterior segment inflammation) as per ISO 11980:2012, any previous history or signs of a contact lens related corneal inflammatory event (past corneal ulcers), or any other ocular abnormality that may contraindicate contact lens wear at the enrolment visit.
• • xii. History of herpetic keratitis, ocular surgery or irregular cornea.
• • xiii. Enrolment of the family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals.