Clinical Evaluation of Biomedics Monthly Sphere and Avaira Vitality Sphere

Ametropia Clinical Trial

Official title:

Clinical Evaluation of Biomedics Monthly Sphere and Avaira Vitality Sphere

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06400914
• Other study ID #: EX-MKTG-156
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2, 2024
• Est. completion date: May 6, 2024

Study information

• Verified date: April 2024
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the short-term clinical performance of two sphere contact lenses.

Description:

The aim of this study is to evaluate the short-term clinical performance of two different sphere contact lenses after 15 minutes of daily wear each.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: May 6, 2024
• Est. primary completion date: May 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Is at least 18 years of age and has full legal capacity to volunteer.

2. Has read and signed an information consent letter.

3. Self-reports having a full eye examination in the previous two years.

4. Anticipates being able to wear the study lenses for the required time of the study.

5. Is willing and able to follow instructions and maintain the appointment schedule.

6. Has refractive astigmatism no higher than -0.75 DC.

7. Can be fit with the available lens parameters (sphere +6.00 to -10.00D).

8. Can achieve binocular distance vision of at least 20/30 Snellen (logMAR 0.18) with the study contact lenses.

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study.

2. Has any known active ocular disease and/or infection that contraindicates contact lens wear.

3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.

4. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable.

5. Has known sensitivity to the diagnostic sodium fluorescein used in the study.

6. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment.

7. Has undergone refractive error surgery or intraocular surgery.

Related Conditions & MeSH terms

• Ametropia
• Refractive Errors

Intervention

Device:
• Lens A (ocufilcon D)
15 minutes of daily wear.
• Lens B (fanfilcon A)
15 minutes of daily wear.

Locations

Country	Name	City	State
Mexico	Consultorio Optométrico Queretaro	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lens Fit Acceptance Ratings	Overall lens fit acceptance will be measured on a scale from 0-4 (0=Should not be worn and 4= Perfect)	15 Minutes