A Study to Evaluate the Safety and Efficacy of Kalifilcon A Daily Disposable Contact Lens

• ClinicalTrials.gov Identifier: NCT04158466
• Recruitment Status: Completed
• First Posted: November 8, 2019
• Results First Posted: November 19, 2020
• Last Update Posted: November 19, 2020
• Sponsor: Bausch & Lomb Incorporated
• Information provided by (Responsible Party): Bausch & Lomb Incorporated

Study Description

Brief Summary:

This study is to evaluate the safety and efficacy of a new silicone hydrogel daily disposable contact lens, kalifilcon A compared to the Bausch + Lomb Biotrue ONE day® daily disposable contact lens when worn by current soft contact lens wearers on a daily disposable wear basis.

Condition or disease	Intervention/treatment	Phase
Contact Lens Wear	Device: Kalifilcon A Daily Disposable Contact Lenses; Device: Biotrue ONEday Daily Disposable Contact Lenses	Not Applicable

Detailed Description:

Approximately 247 participants (494 eyes) will be enrolled in at approximately 20 investigative sites in the United States (US). A minimum of 20% of the randomized participants will be of Japanese descent (for example, both maternal and paternal grandparents born in Japan).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 252 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Supportive Care
• Official Title: A Study to Evaluate the Safety and Efficacy of a Kalifilcon A Contact Lens for Daily Disposable Use
• Actual Study Start Date: May 31, 2019
• Actual Primary Completion Date: November 12, 2019
• Actual Study Completion Date: November 12, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Kalifilcon A Daily Disposable Contact Lenses; Participants will wear Bausch + Lomb kalifilcon A daily disposable contact lenses for at least 8 hours per day at least 5 days per week for approximately 3 months. Participants will be provided with Bausch + Lomb Sensitive Eyes Drops for use as needed during the study and lens cases for return of worn study lenses to the Investigator at the end of the study.	Device: Kalifilcon A Daily Disposable Contact Lenses; Contact lens
Active Comparator: Biotrue ONEday Daily Disposable Contact Lenses; Participants will wear Bausch + Lomb Biotrue ONEday daily disposable contact lenses for at least 8 hours per day at least 5 days per week for approximately 3 months. Participants will be provided with Bausch + Lomb Sensitive Eyes Drops for use as needed during the study and lens cases for return of worn study lenses to the Investigator at the end of the study.	Device: Biotrue ONEday Daily Disposable Contact Lenses; Contact lens; Other Name: Bausch + Lomb Biotrue ONEday® Daily Contact Lens

Outcome Measures

Primary Outcome Measures :

1. Mean logMAR Contact Lens Visual Acuity [ Time Frame: 3 months ]
   Visual acuity (VA) will be reported as letters read correctly, and the letters read will be converted to logarithm of the minimum angle of resolution (logMAR) acuity. The participant will read rows of letters on a standard LogMAR chart until the participant misses 3 letters on a row with 5 letters. The total number of correct letters will be recorded. A decrease in the number of correct letters indicates a decrease in visual acuity. Acuity will be averaged across visits.
2. Proportion of Participants With Slit Lamp Findings Greater Than Grade 2 [ Time Frame: 3 months ]
   During an examination of both eyes without lenses, graded slit lamp findings will be assessed for each eye using Grades 0 (none), 1 (trace), 2 (mild), 3 (moderate), and 4 (severe). Using only the non-missing observations from all visits without imputation, each eye will be classified with respect to findings greater than Grade 2 at any visit (Absent or Present). Epithelial edema, epithelial microcysts, corneal staining, limbal Injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates will be evaluated.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Participants must be able to read, understand, and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF) and provide authorization as appropriate for local privacy regulations.
• Participants must be myopic and require lens correction from -0.25 to -6.00 Diopter (D) with 0.25 D steps, in each eye.
• Participants must be correctable through spherocylindrical refraction and with soft spherical contact lenses to 40 letters (0.14 logMAR) or better (2 meters distance, high-contrast chart) in each eye.
• Participants must be free of any anterior segment disorders.
• Participants must be adapted soft contact lens wearers and willing to wear their study lenses for at least 8 hours per day at least 5 days per week on a daily disposable wear basis for approximately 3 months.
• Participants 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 other contact lenses or solutions other than those provided for the duration of the study.

Exclusion Criteria:

• Participation in any drug or device clinical investigation within 2 weeks prior to entry into this study (Screening/Dispensing Visit) and/or during the period of study participation.
• Participants who are women of childbearing potential (those who are not surgically sterilized or postmenopausal) are excluded from participation in the investigation if they are currently pregnant, plans to become pregnant during the study, or is breastfeeding
• Participants 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.
• Participants with any systemic disease currently affecting ocular health or in the Investigator's opinion may have an effect on ocular health during the course of the study.
• Participants using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
• Participants with an active ocular disease or who are using any ocular medication.
• Participants who currently wear monovision, multifocal, or toric contact lenses.
• Participants with an ocular astigmatism of greater than 1.00 D in either eye.
• Participants with anisometropia (spherical equivalent) of greater than 2.00 D.
• Participants with any Grade 2 or greater finding during the slit lamp examination. Participants with corneal infiltrates of any grade.
• Participants with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
• Participants with any scar or neovascularization within the central 6 millimeters (mm) of the cornea.
• Participants who are aphakic.
• Participants who are amblyopic.
• Participants who have had any corneal surgery (for example, refractive surgery).
• Participants who are allergic to any component in the study care products.
• The participant is an employee of the investigative site.
• The participant, or a member of the participant's household, is an Ophthalmologist, an Optometrist, an Optician, or an Ophthalmic Assistant/Technician.
• The participant, or a member of the participant's household, is an employee of a manufacturer of contact lenses or contact lens care products (for example, Alcon, Bausch + Lomb, Ciba Vision, CooperVision, Johnson & Johnson).
• The participant, or a member of the participant's household, is an employee of a market research firm.

Contacts and Locations

Locations

United States, California

Bausch Site 8

Los Angeles, California, United States, 90012

Bausch Site 9

San Francisco, California, United States, 94112

Bausch Site 10

Torrance, California, United States, 90503

Bausch Site 12

Torrance, California, United States, 90505

United States, Florida

Bausch Site 6

Sarasota, Florida, United States, 34237

United States, Hawaii

Bausch Site 4

'Aiea, Hawaii, United States, 96701

Bausch Site 16

Honolulu, Hawaii, United States, 96814

United States, Kansas

Bausch Site 7

Pittsburg, Kansas, United States, 66762

United States, Minnesota

Bausch Site 11

Bloomington, Minnesota, United States, 61701

United States, Missouri

Bausch Site 1

Saint Louis, Missouri, United States, 63144

United States, New York

Bausch Site 13

Vestal, New York, United States, 13850

United States, Pennsylvania

Bausch Site 2

State College, Pennsylvania, United States, 16801

United States, Tennessee

Bausch Site 14

Brentwood, Tennessee, United States, 37027

Bausch Site 5

Memphis, Tennessee, United States, 38119

Bausch Site 3

Nashville, Tennessee, United States, 37205

United States, Wisconsin

Bausch Site 15

New Berlin, Wisconsin, United States, 53151

Sponsors and Collaborators

Bausch & Lomb Incorporated

Investigators

• Study Director: Daniel Donatello; Bausch & Lomb Incorporated

  Study Documents (Full-Text)

Documents provided by Bausch & Lomb Incorporated:

Study Protocol and Statistical Analysis Plan  [PDF] August 9, 2019

More Information

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT04158466
• Other Study ID Numbers: 890
• First Posted: November 8, 2019
• Results First Posted: November 19, 2020
• Last Update Posted: November 19, 2020
• Last Verified: October 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by Bausch & Lomb Incorporated:

Disposable Contact Lenses; Soft Contact Lens; Soft Contact Lenses