NCT04555031

Brief Summary

Approximately 20 habitual soft contact lens wearing participants will be enrolled in this unilateral, randomized, double-masked (participant and investigator masked) repeated measures insertion study. All participants will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If participants satisfy all eligibility criteria and none of the exclusion criteria, subjects will insert study lenses in random, successive order according to unique randomization schedules that will be provided to each Investigator.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 9, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2020

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 8, 2021

Completed
Last Updated

November 8, 2021

Status Verified

October 1, 2021

Enrollment Period

7 days

First QC Date

September 11, 2020

Results QC Date

August 18, 2021

Last Update Submit

October 8, 2021

Conditions

Habitual Soft Contact Lens Use

Outcome Measures

Primary Outcomes (3)

  • Surface Refractive Index Shifts at 5 Minutes

    Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units.

    5 minutes

  • Surface Refractive Index Shifts at 10 Minutes

    Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units.

    10 minutes

  • Surface Refractive Index Shifts at 15 Minutes

    Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units.

    15 minutes

Study Arms (4)

kalifilcon A lenses

EXPERIMENTAL
Device: kalifilcon A lenses

Dailies Total 1

ACTIVE COMPARATOR
Device: Dalies Total 1

Precision 1

ACTIVE COMPARATOR
Device: Precision 1

Biotrue ONEday

ACTIVE COMPARATOR
Device: Biotrue ONEday

Interventions

kalifilcon A lensesDEVICE

Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.

kalifilcon A lenses
Dalies Total 1DEVICE

Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.

Dailies Total 1
Precision 1DEVICE

Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.

Precision 1
Biotrue ONEdayDEVICE

Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.

Biotrue ONEday

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older and have full legal capacity to volunteer.
  • Physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
  • No active ocular disease or allergic conjunctivitis.
  • Not using any topical ocular medications.
  • Willing and able to follow instructions.
  • Signed a statement of informed consent.

You may not qualify if:

  • Participating in a conflicting study in the opinion of the Investigator.
  • Considered by the Investigator to not be a suitable candidate for participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bausch and Lomb Site 01

Rochester, New York, 14609, United States

Location

Results Point of Contact

Title
Study Director
Organization
Bausch & Lomb
robert.steffen@bausch.com
5853386399

Study Officials

  • Jeffery Schafer, OD

    Bausch & Lomb Incorporated

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2020

First Posted

September 18, 2020

Study Start

September 9, 2020

Primary Completion

September 16, 2020

Study Completion

September 16, 2020

Last Updated

November 8, 2021

Results First Posted

November 8, 2021

Record last verified: 2021-10

Locations

US(1)