Clinical Investigation of Buttermere (LENS 271) Soft Contact Lenses

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
United Kingdom
Ocular Technology Group - International
RECRUITING
London
Contact Information
Primary
Lee Hall, PhD, BSc
lhall@coopervision.com
+19252516684
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2024-12-15
Participants
Target number of participants: 80
Treatments
Experimental: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: CooperVision, Inc.

This content was sourced from clinicaltrials.gov