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Performance Evaluation of Two Silicone Hydrogel Toric Lens Designs in Habitual Soft Contact Lens Wearers

Sponsor
Coopervision, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05933772
Collaborator
CORE (Other)
60
Enrollment
4
Locations
2
Arms
3
Anticipated Duration (Months)
15
Patients Per Site
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of the study is to compare the clinical performance of two monthly toric silicone hydrogel contact lenses in habitual wearers, when worn for 1-month each.

Condition or Disease Intervention/Treatment Phase
  • Device: Lens A (comfilcon A toric lens)
  • Device: Lens B (lehfilcon A toric lens)
 N/A

Detailed Description

This study is a prospective, bilateral eye, subjected-masked, randomized, 1-month cross-over, daily-wear design involving two different silicone hydrogel toric lens types. Each lens type will be worn bilaterally for approximately one month.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Performance Evaluation of Two Silicone Hydrogel Toric Lens Designs in Habitual Soft Contact Lens Wearers
Anticipated Study Start Date :
Jul 31, 2023
Anticipated Primary Completion Date :
Oct 30, 2023
Anticipated Study Completion Date :
Oct 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lens A, Then Lens B

Participants will wear Lens A for one month and then crossover to Lens B for one month.

Device: Lens A (comfilcon A toric lens)
One month wear

Device: Lens B (lehfilcon A toric lens)
One month wear
Experimental: Lens B, Then Lens A

Participants will wear Lens B for one month and then crossover to Lens A for one month.

Device: Lens A (comfilcon A toric lens)
One month wear

Device: Lens B (lehfilcon A toric lens)
One month wear

Outcome Measures

Primary Outcome Measures

  1. Lens Handling on Removal [One month of wear]

    Lens Handling on Removal, using a 0-100 scale (0= Worst, 100=Best)

Secondary Outcome Measures

  1. Distance Visual Acuity [One month wear]

    Distance Visual Acuity, using Snellen converted to logMAR

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 39 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  1. Is between 18 and 39 years of age (inclusive) and has full legal capacity to volunteer;

  2. Has read and signed an information consent letter;

  3. Self-reports having a full eye examination in the previous two years;

  4. Anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week;

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

  6. Habitually wears of toric soft contact lenses binocularly.

  7. No more than 1/3 of the participants should be wearing daily disposable soft toric lenses;

  8. the remaining 2/3+ of the participants must be planned frequent replacement soft toric lens wearers as follows:

    1. TOTAL30 for Astigmatism: maximum of 3 (∼10%) (no target percentage
    1. Biofinity toric: maximum of 13 (∼40%) (PLUS a target of minimum 10 (∼30%))
    1. Air Optix for Astigmatism (inclusive of +Hydraglyde): maximum of 10 (∼30%) (PLUS a target of minimum 7 (∼20%))
    1. ULTRA for Astigmatism: maximum of 5 (∼15%) (no target percentage)
    1. Acuvue Vita for Astigmatism: maximum of 3 (∼10%) (no target percentage)
    1. Acuvue Oasys for Astigmatism: maximum of 10 (∼30%) (no target percentage)
    1. Other brands of frequent replacement: maximum of 7 (∼20%) (no target percentage)

  1. Has refractive astigmatism of at least -0.75DC but no more than -2.75DC in each eye that is correctable with a soft toric lens with a cylinder power of no greater than -2.25DC;

  2. Is ammetropic and requires a spectacle spherical component of +8.00 to -10.00D inclusively;

  3. Can be fit and achieve binocular distance vision of at least 20/32 Snellen with the available lens parameters

Exclusion Criteria:

  1. Is participating in any concurrent clinical or research study;

  2. Has any known active ocular disease and/or infection that contraindicates contact lens wear;

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

  4. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;

  5. Has known sensitivity to the diagnostic sodium fluorescein used in the study;

  6. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;

  7. Has undergone refractive error surgery or intraocular surgery.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sacco Eye Group Vestal New York United States 13850
2 ProCare Vision Center Granville Ohio United States 43023
3 Eyes on Sheppard Clinic Toronto Ontario Canada M2N 3A4
4 Spadina Optometry Toronto Ontario Canada M5V 3E7

Sponsors and Collaborators

  • Coopervision, Inc.
  • CORE

Investigators

  • Principal Investigator: Andrew Sacco, Sacco Eye Group
  • Principal Investigator: David Wilkinson, Spadina Optometry
  • Principal Investigator: Fiona Soong, Eyes on Sheppard Clinic
  • Principal Investigator: Katherine Bickle, ProCare Vision Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT05933772
Other Study ID Numbers:
  • EX-MKTG-149
First Posted:
Jul 6, 2023
Last Update Posted:
Jul 7, 2023
Last Verified:
May 1, 2023
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
Additional relevant MeSH terms:
Astigmatism

Study Results

No Results Posted as of Jul 7, 2023