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Comparing Somofilcon A Monthly Replacement Versus Omafilcon A Daily Disposable

Sponsor
Coopervision, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06046209
Collaborator
CORE (Other)
30
Enrollment
1
Location
2
Arms
2
Anticipated Duration (Months)
15.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Control Contact Lens (omafilcon A)
  • Device: Test Contact Lens (somofilcon A)
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Comparing Clariti Elite Versus Proclear 1 Day
Anticipated Study Start Date :
Sep 25, 2023
Anticipated Primary Completion Date :
Nov 24, 2023
Anticipated Study Completion Date :
Nov 24, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Control Lens, then Test Lens

Participants will be randomized to wear the Control Lens for 90 minutes, then crossover to the Test Lens for 90 minutes.

Device: Control Contact Lens (omafilcon A)
Daily disposable

Device: Test Contact Lens (somofilcon A)
Monthly replacement
Experimental: Test Lens, then Control Lens

Participants will be randomized to wear the Test Lens for 90 minutes, then crossover to the Control Lens for 90 minutes.

Device: Control Contact Lens (omafilcon A)
Daily disposable

Device: Test Contact Lens (somofilcon A)
Monthly replacement

Outcome Measures

Primary Outcome Measures

  1. Lens Handling at Insertion [90 minutes of wear]

    Binocular subjective rating of the ease of lens application to eye, using a 0-100 scale (0=Very difficult, 100=Very easy)

Eligibility Criteria

Criteria

Ages Eligible for Study:
17 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Waterloo School of Optometry & Vision Science Waterloo Ontario Canada N2L 3G1

Sponsors and Collaborators

  • Coopervision, Inc.
  • CORE

Investigators

  • Principal Investigator: Lyndon Jones, PhD FCOptom, Centre for Ocular Research and Education (CORE)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT06046209
Other Study ID Numbers:
  • CV-23-36
First Posted:
Sep 21, 2023
Last Update Posted:
Sep 21, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Coopervision, Inc.
Refractive Errors
Eye Diseases
Additional relevant MeSH terms:
Hyperopia

Study Results

No Results Posted as of Sep 21, 2023