Clinical Investigation of Buttermere (LENS 271) Soft Contact Lenses

NCT ID: NCT06609018

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2024-12-15

Brief Summary

The purpose of the study is to compare clinical performance between two soft contact lenses.

Detailed Description

The purpose of this study is to compare clinical performance of two soft contact lenses in a crossover study over a period of 7 days of wear.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Test Lenses, Then Control Lenses

Participants will wear the Test Lenses in both eyes for one week and then cross over to the Control Lenses in both eyes for one week.

Group Type: EXPERIMENTAL

Test Lenses (stenfilcon A)

Intervention Type: DEVICE

Daily disposable, soft contact lenses worn for one week

Control Lenses (omafilcon A)

Intervention Type: DEVICE

Daily disposable, soft contact lenses worn for one week

Control Lenses, Then Test Lenses

Participants will wear the Control Lenses in both eyes for one week and then cross over to the Test Lenses in both eyes for one week.

Group Type: EXPERIMENTAL

Test Lenses (stenfilcon A)

Intervention Type: DEVICE

Daily disposable, soft contact lenses worn for one week

Control Lenses (omafilcon A)

Intervention Type: DEVICE

Daily disposable, soft contact lenses worn for one week

Interventions

Test Lenses (stenfilcon A)

Daily disposable, soft contact lenses worn for one week

Intervention Type: DEVICE

Control Lenses (omafilcon A)

Daily disposable, soft contact lenses worn for one week

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michel Guillon, PhD

Role: PRINCIPAL_INVESTIGATOR

Ocular Technology Group- International

Locations

Ocular Technology Group - International

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Lee Hall, PhD, BSc

Role: CONTACT

lhall@coopervision.com

+19252516684

Facility Contacts

Michel Guillon, PhD

Role: primary

Other Identifiers

CV-23-02

Identifier Type: -

Identifier Source: org_study_id