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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

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).

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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

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




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.



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158466


Locations
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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
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Study Director: Daniel Donatello Bausch & Lomb Incorporated
  Study Documents (Full-Text)

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

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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