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

NCT04158466 | Completed Results FDA Device

• 1 other identifier: 890
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 16

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.

Conditions

Contact Lens Wear

Keywords

Disposable Contact Lenses; Soft Contact Lens; Soft Contact Lenses

Outcome Measures

Primary Outcomes (2)

• Mean logMAR Contact Lens Visual Acuity

  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.

  3 months

• Proportion of Participants With Slit Lamp Findings Greater Than Grade 2

  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.

  3 months

Study Arms (2)

Kalifilcon A Daily Disposable Contact Lenses

EXPERIMENTAL

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

Biotrue ONEday Daily Disposable Contact Lenses

ACTIVE COMPARATOR

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

Interventions

Kalifilcon A Daily Disposable Contact Lenses DEVICE

Contact lens

Kalifilcon A Daily Disposable Contact Lenses

Biotrue ONEday Daily Disposable Contact Lenses DEVICE

Contact lens

Also known as: Bausch + Lomb Biotrue ONEday® Daily Contact Lens

Biotrue ONEday Daily Disposable Contact Lenses

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (16)

Bausch Site 8

Los Angeles, California, 90012, United States

Location

Bausch Site 9

San Francisco, California, 94112, United States

Location

Bausch Site 10

Torrance, California, 90503, United States

Location

Bausch Site 12

Torrance, California, 90505, United States

Location

Bausch Site 6

Sarasota, Florida, 34237, United States

Location

Bausch Site 16

Honolulu, Hawaii, 96814, United States

Location

Bausch Site 4

‘Aiea, Hawaii, 96701, United States

Location

Bausch Site 7

Pittsburg, Kansas, 66762, United States

Location

Bausch Site 11

Bloomington, Minnesota, 61701, United States

Location

Bausch Site 1

St Louis, Missouri, 63144, United States

Location

Bausch Site 13

Vestal, New York, 13850, United States

Location

Bausch Site 2

State College, Pennsylvania, 16801, United States

Location

Bausch Site 14

Brentwood, Tennessee, 37027, United States

Location

Bausch Site 5

Memphis, Tennessee, 38119, United States

Location

Bausch Site 3

Nashville, Tennessee, 37205, United States

Location

Bausch Site 15

New Berlin, Wisconsin, 53151, United States

Location

Results Point of Contact

• Title: Study Director
• Organization: Bausch Health

robert.steffen@bausch.com

(585) 338-6399

Study Officials

• Daniel Donatello

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 8, 2019
• Study Start: May 31, 2019
• Primary Completion: November 12, 2019
• Study Completion: November 12, 2019
• Last Updated: November 19, 2020
• Results First Posted: November 19, 2020

Record last verified: 2020-10

Locations

US (16)