Clinical Evaluation of Two Daily Disposable Lenses in Sphere Design

Ametropia Clinical Trial

Official title:

Clinical Evaluation of Two Daily Disposable Lenses in Sphere Design

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05516082
• Other study ID #: EX-MKTG-141
• Status: Completed
• Phase: N/A
• Start date: August 8, 2022
• Est. completion date: October 12, 2022

Study information

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

Clinical Trial Summary

This was a single-blind, interventional, prospective, direct refit, bilateral wear, fixed-sequence crossover study.

Description:

The aim of this study was to evaluate the visual performance and subjective experiences of daily disposable hydrogel lens (DDH) when compared to daily disposable silicone hydrogel lens (DDSH) after 15 minutes of daily wear each.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 12, 2022
• Est. primary completion date: October 12, 2022
• Accepts healthy volunteers: No
• 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 the required time of the study.

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

• Has refractive astigmatism no higher than -0.75 DC.

• Can be fit with the available lens parameters (sphere +8.00 to -10.00D).

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

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

• Ametropia
• Refractive Errors

Intervention

Device:
• Lens A
DDH contact lens for 15 minutes
• Lens B
DDSH contact lens for 15 minutes

Locations

Country	Name	City	State
Mexico	Dr. Ruben Velazquez Private Practice	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	Measured on a scale of 0-4 (0 = Should not be worn, 1 = Borderline but unacceptable, 2 = Min. acceptable, early review, 3 = Not perfect but OK to dispense, 4 = Perfect) as assessed by an investigator.	15 minutes