Trials Sponsors Conditions Drugs Pricing

Conditions

Contact Lens Wear

Keywords

Disposable Contact LensesSoft Contact LensSoft 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 LensesDevice

Contact lens

Kalifilcon A Daily Disposable Contact Lenses

Biotrue ONEday Daily Disposable Contact LensesDevice

Contact lens

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

Biotrue ONEday Daily Disposable Contact Lenses

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (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.

Sponsors & Collaborators

Bausch & Lomb Incorporated
Industrylead

Study Sites (16)

Bausch Site 8

Los Angeles, California, 90012, United States

Bausch Site 9

San Francisco, California, 94112, United States

Bausch Site 10

Torrance, California, 90503, United States

Bausch Site 12

Torrance, California, 90505, United States

Bausch Site 6

Sarasota, Florida, 34237, United States

Bausch Site 16

Honolulu, Hawaii, 96814, United States

Bausch Site 4

‘Aiea, Hawaii, 96701, United States

Results Point of Contact

Title: Study Director
Organization: Bausch Health

Study Officials

Daniel Donatello
Bausch & Lomb Incorporated
STUDY DIRECTOR

Publication Agreements

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

Enrollment

252 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Kalifilcon A Daily Disposable Contact Lenses

Biotrue ONEday Daily Disposable Contact Lenses

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (16)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Kalifilcon A Daily Disposable Contact Lenses

Biotrue ONEday Daily Disposable Contact Lenses

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (16)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations