Clinical Investigation of Buttermere (LENS 271) Soft Contact Lenses

NCT06609018 | Completed FDA Device

• 1 other identifier: CV-23-02
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myopia

Outcome Measures

Primary Outcomes (3)

• Total Absolute Decentration

  Total absolute decentration from pupil centre in mm at one-week follow-up visits after at least three hours of wear. Decentration for the eye in primary position (relaxed, looking straight ahead) will be measured on three-point scale where 0= optimal lens centration , 1 = acceptable decentration and 2= unacceptable decentration.

  At the end of one week daily disposable wear, after at least three hours of wear.

• Contact Lens Centration

  Contact lens centration clinical rating at one-week follow-up visits after at least three hours of wear. Centration for the eye in primary position (relaxed, looking straight ahead) will be measured on three-point scale where 0= optimal lens centration, 1 = acceptable decentration and 2= unacceptable decentration.

  At the end of one week daily disposable wear, after at least three hours of wear.

• Contact Lens Movement

  Contact lens movement at blink clinical rating at one-week follow-up visits after at least three hours of wear. Contact Lens Movement will be recorded: a) for the eye in the primary position immediately after the blink; b) for the recovery movement following digitally applied lower lid margin push-up with the lower lid as follows: (-2) = reduced movement unacceptable (-1) = reduced movement acceptable (0) = optimal movement (+1) = excessive movement acceptable (+2) = excessive movement unacceptable

  At the end of one week daily disposable wear, after at least three hours of wear.

Study Arms (2)

Test Lenses, Then Control Lenses

EXPERIMENTAL

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.

Device: Test Lenses (stenfilcon A); Device: Control Lenses (omafilcon A)

Control Lenses, Then Test Lenses

EXPERIMENTAL

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.

Device: Test Lenses (stenfilcon A); Device: Control Lenses (omafilcon A)

Interventions

Test Lenses (stenfilcon A) DEVICE

Daily disposable, soft contact lenses worn for one week

Control Lenses, Then Test Lenses; Test Lenses, Then Control Lenses

Control Lenses (omafilcon A) DEVICE

Daily disposable, soft contact lenses worn for one week

Control Lenses, Then Test Lenses; Test Lenses, Then Control Lenses

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

Ocular Technology Group - International

London, SW1E 6AU, United Kingdom

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Michel Guillon, PhD

  Ocular Technology Group- International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study includes a second phase (Parallel) that has no primary or secondary outcome measures.

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 23, 2024
• Study Start: August 1, 2024
• Primary Completion: March 5, 2025
• Study Completion: March 5, 2025
• Last Updated: February 24, 2026

Record last verified: 2025-12

Locations

GB (1)