Comparing a Monthly Replacement Lens Versus a Daily Disposable Lens

Comparing Clariti Elite Versus Proclear 1 Day

The purpose of this study was to compare subjective ratings of lens handling at insertion for a monthly replacement lens versus a daily disposable lens in habitual soft lens wearers.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Control Lens; Device: Test Lens

Detailed Description

This was a non-dispensing, randomized, double-masked, crossover study. Participants wore 2 different contact lenses bilaterally over 4 study visits, all conducted on the same day. Estimated duration of involvement for each participant was 4 hours.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • University of Waterloo School of Optometry & Vision Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Were 17 to 40 years of age and have full legal capacity to volunteer;
2. Had read and signed an information consent letter;
3. Were willing and able to follow instructions and maintain the appointment schedule;
4. Were habitual daily wearers of spherical single vision soft contact lenses to correct for distance vision in each eye
5. Were correctable to a visual acuity of 20/20 or better (in each eye) with sphero-cylindrical subjective refraction;
6. Had an astigmatism of ≤ 0.75DC in subjective refraction;
7. Could be fit with the study contact lenses with a power between -1.00 and -6.00DS; this translates to best corrected vision sphere refraction that vertexes to a CL power between -1.00 and -6.00 (inclusive) at screening visit.
8. Demonstrated an acceptable fit with the study lenses.

Exclusion Criteria:

1. Had taken part in another clinical research study within the last 14 days;
2. Were currently habitual wearers of toric, multifocal or monovision lenses.
3. Had worn any rigid contact lenses in the past 6 months
4. Were an extended lens wearer (i.e., sleeping with their lenses)
5. Had a difference of ≥1.5 D in best vision sphere subjective refraction between eyes;
6. Had amblyopia and/or distance strabismus/binocular vision problem;
7. Had any known active ocular disease, allergies and/or infection;
8. Had a systemic condition that in the opinion of the investigator may affect a study outcome variable;
9. Were using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
10. Had a known sensitivity to the diagnostic pharmaceuticals to be used in the study;
11. Had undergone refractive error surgery or intraocular surgery;
12. Were a member of CORE directly involved in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control Lens, then Test Lens; Participants wore the Control Lens for 90 minutes, then the Test Lens for 90 minutes.	Device: Control Lens; Daily disposable contact lens for 90 minutes; Device: Test Lens; Monthly replacement contact lens for 90 minutes
Experimental: Test Lens, then Control Lens; Participants wore the Test Lens for 90 minutes, then the Control Lens for 90 minutes.	Device: Control Lens; Daily disposable contact lens for 90 minutes; Device: Test Lens; Monthly replacement contact lens for 90 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Handling at Insertion	Participants completed subjective ratings of the ease of application of the study lenses to eye immediately after lens application on a 0-100 integer scale, where 100=very easy and 0=very difficult.	Immediately after lens application

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Collaborators: Centre for Ocular Research & Education, Canada
• Investigators: Principal Investigator: Lyndon Jones, PhD FCOptom, Centre for Ocular Research and Education (CORE)

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2023
• Primary Completion (Actual): November 22, 2023
• Study Completion (Actual): November 22, 2023

Study Registration Dates

• First Submitted: September 14, 2023
• First Submitted That Met QC Criteria: September 19, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Eye Diseases; Refractive Errors
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CV-23-36

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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