Clinical Evaluation of Two Daily Disposable Lenses in Sphere Design

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

Study Overview

• Status: Completed
• Conditions: Ametropia
• Intervention / Treatment: Device: Lens A; Device: Lens B

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 06700
    • Dr. Ruben Velazquez Private Practice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lens A; All participants wore Lens A for 15 minutes (Period 1)	Device: Lens A; DDH contact lens for 15 minutes
Experimental: Lens B; All participants wore Lens B for 15 minutes (Period 2)	Device: Lens B; DDSH contact lens for 15 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Rubén V Guerrero, MSc., FIACLE, Dr. Ruben Velazquez Private Practice

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2022
• Primary Completion (Actual): October 12, 2022
• Study Completion (Actual): October 12, 2022

Study Registration Dates

• First Submitted: August 23, 2022
• First Submitted That Met QC Criteria: August 23, 2022
• First Posted (Actual): August 25, 2022

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: EX-MKTG-141

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes