NCT04840563

Brief Summary

Approximately 10 habitual soft contact lens wearing participants will be enrolled in this bilateral, 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, participants 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 Apr 2021

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

First Submitted

Initial submission to the registry

April 7, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

April 7, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 12, 2021

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2021

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

8 days

First QC Date

April 7, 2021

Last Update Submit

July 20, 2021

Conditions

Habitual Soft Contact Lens Use

Outcome Measures

Primary Outcomes (1)

  • Surface refractive index shifts

    Immediately following lens removal, the right eye worn lenses for each subject will be measured for surface refractive index on the refractometer.

    10 minutes

Study Arms (3)

Kalifilcon A lenses

EXPERIMENTAL

Commercially available kalifilcon A lenses (Bausch + Lomb)

Device: Kalifon A

Dailies Total1

ACTIVE COMPARATOR

Dailies Total1 (Alcon)

Device: Dailies Total1

Precision1

ACTIVE COMPARATOR

Precision1 (Alcon)

Device: Precision1

Interventions

Kalifon ADEVICE

Commercially available kalifilcon A lenses

Kalifilcon A lenses
Dailies Total1DEVICE

Dailies Total1

Dailies Total1
Precision1DEVICE

Precision1

Precision1

Eligibility Criteria

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

You may qualify if:

  • Be 18 years or older and have full legal capacity to volunteer.
  • Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
  • Have no active ocular disease or allergic conjunctivitis.
  • Not be using any topical ocular medications.
  • Be willing and able to follow instructions.
  • Have 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 Site 001

Rochester, New York, 14609, United States

Location

Study Officials

  • Jeffery Schafer, OD

    Bausch & Lomb Incorporated

    PRINCIPAL INVESTIGATOR

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

April 7, 2021

First Posted

April 12, 2021

Study Start

April 7, 2021

Primary Completion

April 15, 2021

Study Completion

April 15, 2021

Last Updated

July 22, 2021

Record last verified: 2021-07

Locations

US(1)