Comparing a Monthly Replacement Lens Versus a Daily Disposable Lens

Myopia Clinical Trial

Official title:

Comparing Clariti Elite Versus Proclear 1 Day

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06046209
• Other study ID #: CV-23-36
• Status: Completed
• Phase: N/A
• Start date: September 28, 2023
• Est. completion date: November 22, 2023

Study information

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

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 22, 2023
• Est. primary completion date: November 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Are 17 to 40 years of age and have full legal capacity to volunteer;

2. Have read and signed an information consent letter;

3. Are willing and able to follow instructions and maintain the appointment schedule;

4. Are habitual daily wearers of spherical single vision soft contact lenses to correct for distance vision in each eye

5. Are correctable to a visual acuity of 20/20 or better (in each eye) with sphero-cylindrical subjective refraction;

6. Have an astigmatism of = 0.75DC in subjective refraction;

7. Can 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. Demonstrate an acceptable fit with the study lenses.

Exclusion Criteria:

1. Have taken part in another clinical research study within the last 14 days;

2. Are currently habitual wearers of toric, multifocal or monovision lenses.

3. Have worn any rigid contact lenses in the past 6 months

4. Are an extended lens wearer (i.e., sleeping with their lenses)

5. Have a difference of =1.5 D in best vision sphere subjective refraction between eyes;

6. Have amblyopia and/or distance strabismus/binocular vision problem;

7. Have any known active ocular disease, allergies and/or infection;

8. Have a systemic condition that in the opinion of the investigator may affect a study outcome variable;

9. Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;

10. Have a known sensitivity to the diagnostic pharmaceuticals to be used in the study;

11. Have undergone refractive error surgery or intraocular surgery;

12. Are a member of CORE directly involved in the study.

Related Conditions & MeSH terms

• Hyperopia
• Myopia

Intervention

Device:
• Control Contact Lens
Daily disposable contact lens for 90 minutes
• Test Contact Lens
Monthly replacement contact lens for 90 minutes

Locations

Country	Name	City	State
Canada	University of Waterloo School of Optometry & Vision Science	Waterloo	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Coopervision, Inc.	CORE

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lens Handling at Insertion	Binocular subjective rating of the ease of lens application to eye, using a 0-100 scale (0=Very difficult, 100=Very easy)	90 minutes of wear