Clinical Evaluation of Two Frequent Replacement Soft Spherical Contact Lenses

Myopia Clinical Trial

Official title:

Clinical Evaluation of Proclear Monthly and Avaira Vitality

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05656885
• Other study ID #: EX-MKTG-142
• Status: Completed
• Phase: N/A
• Start date: September 27, 2022
• Est. completion date: October 18, 2022

Study information

• Verified date: December 2022
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This was a single-blind (participant masked), interventional, prospective, direct refit, bilateral wear short-term fitting study.

Description:

The aim of this non-dispensing fitting study was to evaluate the short-term clinical performance of two soft spherical contact lenses after 15 minutes of daily wear each.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 18, 2022
• Est. primary completion date: October 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Is at least 18 years of age and has full legal capacity to volunteer.
• Has read and signed an information consent letter.
• Self-reports having a full eye examination in the previous two years.
• Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week.
• Is willing and able to follow instructions and maintain the appointment schedule.
• Habitual soft contact lens wearers who currently wear sphere contact lenses, or use spectacles for all distances vision correction, for the past 3 months minimum.
• Has refractive astigmatism no higher than -0.75DC.
• Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (powers +8.00 to -12.00DS)

Exclusion Criteria:

• Is participating in any concurrent clinical or research study.
• Has any known active ocular disease and/or infection that contraindicates contact lens wear.
• Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
• Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable.
• Has known sensitivity to the diagnostic sodium fluorescein used in the study.
• Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment.
• Has undergone refractive error surgery or intraocular surgery.

Related Conditions & MeSH terms

• Hyperopia
• Myopia

Intervention

Device:
• Lens A
Soft spherical hydrogel contact lens for 15 minutes
• Lens B
Soft spherical silicone hydrogel contact lens for 15 minutes

Locations

Country	Name	City	State
Spain	University Complutense of Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lens Fit Acceptance Rating	Measured on lens fit alone on a scale of 0-4 (0=Should not be used; 1=Limit, but unacceptable; 2=Minimum acceptable, early review; 3=Not perfect, but OK to dispense; 4=Perfect) as assessed by an investigator.	15 minutes