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Evaluation of Product Performance of a New Silicone Hydrogel Multifocal Contact Lens

Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05660577
Collaborator
(none)
300
Enrollment
20
Locations
1
Arm
4.8
Anticipated Duration (Months)
15
Patients Per Site
3.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the product performance of a new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens, when worn by current soft contact lens wearers on a daily disposable wear basis

Condition or Disease Intervention/Treatment Phase
  • Device: new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Study to Evaluate the Product Performance of a New Silicone Hydrogel Multifocal Contact Lens
Actual Study Start Date :
Nov 7, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: e Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens

Device: new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens
new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens

Outcome Measures

Primary Outcome Measures

  1. proportion of subjects agreeing with the statement "Clear vision: near, far, and in-between [3 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Subjects must be age 40 years or older on the date the ICF is signed and have the capacity to provide voluntary informed consent

  2. Subjects must be willing and able to comply with all treatment and follow-up/study procedures, as well as willing and able to refrain from using any contact lenses other than those provided for the duration of the study

  3. Subjects must be correctable through spherocylindrical refraction to 42 letters (0.1 logMAR) or better (distance, high contrast) in each eye

  4. Subjects must have clear central corneas and be free of any anterior segment disorders

  5. Subject must wear their current lenses for a minimum of 12 hours per day at least four days per week

  6. Subjects must habitually wear a multifocal lens in each eye

  7. Subjects must be an adapted multifocal soft contact lens wearer for a minimum of 6 months

  8. Subjects must require distance lens correction from +3.00 to -6.00 D in each eye

  9. Subjects must be presbyopic and require near add correction from +0.75 to +2.50 D in each eye

  10. Subjects must have access to an internet connection to complete an online survey and be able to receive text message

Exclusion Criteria:

Subjects participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or plan to do so during the period of study participation 2. Subjects who are women of childbearing potential (those who are not surgically sterilized or postmenopausal) are excluded from participation in the investigation if they meet any one of the following conditions:

  • She is currently pregnant

  • She plans to become pregnant during the study

  • She is breastfeeding 3. Subjects with any systemic disease currently affecting ocular health or that, in the Investigator's opinion, may have an effect on ocular health during the course of the study 4. Subjects with an active ocular disease 5. Subjects who have had any corneal surgery (e.g., refractive surgery) 6. Subjects who have worn gas-permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last 3 months 7. Subjects who currently wear monovision or toric contact lenses 8. Subjects who are not correctable to 32 letters (0.3 logMAR) with bilateral soft multifocal contact lenses 9. Subjects with an ocular astigmatism >1.00 D in either eye 10. Subjects with anisometropia (spherical equivalent) >2.00 D 11. Subjects with any Grade ≥2 finding during the slit lamp examination. Subjects with corneal infiltrates of ANY GRADE are not eligible 12. Any "Present" finding during the slit lamp examination that, in the Investigator's opinion, interferes with contact lens wear 13. Any scar or neovascularization within the central 6 mm of the cornea. Subjects with minor peripheral corneal scarring (that does not extend into the central area) that, in the Investigator's opinion, does not interfere with contact lens wear are eligible for this study 14. Subjects who are amblyopic 15. Subjects using any systemic or topical ocular medication that will, in the Investigator's opinion, affect ocular physiology or lens performance 16. Subjects who are allergic to any component in the study care products

Contacts and Locations

Locations

Site City State Country Postal Code
1 Eric White OD Inc San Diego California United States 92123
2 Lee & Woo Optometry San Francisco California United States 94112
3 Chester T Roe III MD Prof LLC Denver Colorado United States 80246
4 Pearle Vision Jacksonville Florida United States 32246
5 Eola Eyes Orlando Florida United States 32803
6 Vision Health Institute Orlando Florida United States 32803
7 Golden Vision Sarasota Florida United States 34237
8 The Eyecare Studio, LLC Decatur Georgia United States 30035
9 Family Eyecare Center Leavenworth Kansas United States 66048
10 Kannarr EyeCare Pittsburg Kansas United States 66762
11 Casco Bay EyeCare Portland Maine United States 04101
12 Cornea and Contact Lens Institute of Minnesota Edina Minnesota United States 55436
13 Koetting Associates Saint Louis Missouri United States 63144
14 Spectrum Eyecare Jamestown New York United States 14701
15 Saccco Eye Group Vestal New York United States 13850
16 Oculus Research Raleigh North Carolina United States 27603
17 CORE, Inc. Shelby North Carolina United States 28150
18 West Bay Eye Associates Warwick Rhode Island United States 02888
19 Total Eye Care, PA Memphis Tennessee United States 38119
20 Optometric Physicians of Middle Tennessee Nashville Tennessee United States 37205

Sponsors and Collaborators

  • Bausch & Lomb Incorporated

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT05660577
Other Study ID Numbers:
  • BL916
First Posted:
Dec 21, 2022
Last Update Posted:
Dec 21, 2022
Last Verified:
Dec 1, 2022
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:
Presbyopia
Hyperopia
Refractive Errors

Study Results

No Results Posted as of Dec 21, 2022