Trials Sponsors Conditions Drugs Pricing

Conditions

Contact Lens Wear

Keywords

refractive index

Outcome Measures

Primary Outcomes (1)

Surface Refractive Index of Worn Lenses
Immediately following lens removal, the right-eye worn lens for each participant was measured for surface refractive index on a Metricon M-2010 Prism Coupler. A new lens pair was worn for each wear time. Surface refractive index is a dimensionless ratio and has no units.
Unworn lens (baseline) and immediately after 0.5, 1, 3, 5, and 10 minutes of lens wear

Study Arms (1)

All Participants: kalifilcon A, Then Dailies Total1, Then Precision1

OTHER

Each participant wore all three study lens types bilaterally, one lens type per pair of visits, in the order specified by the study randomization schedule (kalifilcon A, then Dailies Total1, then Precision1). For each lens type a new lens pair was inserted for each wear time of 0.5, 1, 3, 5 and 10 minutes, with a 3-5 minute washout period between lens pairs. Wear times of 0.5, 1 and 3 minutes were completed at one visit and 5 and 10 minutes at another visit, for a total of 6 visits. Immediately after removal the right-eye lens was measured for surface refractive index on a Metricon M-2010 Prism Coupler.

Device: kalifilcon A daily disposable spherical soft contact lensDevice: Dailies Total1 (delefilcon A) daily disposable spherical soft contact lensDevice: Precision1 (verofilcon A) daily disposable spherical soft contact lens

Interventions

kalifilcon A daily disposable spherical soft contact lensDevice

Commercially available Infuse (kalifilcon A) daily disposable spherical soft contact lens, -3.00 D, worn bilaterally for 0.5, 1, 3, 5 and 10 minutes.

Also known as: Infuse

All Participants: kalifilcon A, Then Dailies Total1, Then Precision1

Dailies Total1 (delefilcon A) daily disposable spherical soft contact lensDevice

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

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.

Sponsors & Collaborators

Bausch & Lomb Incorporated
Industrylead

Study Sites (1)

Bausch & Lomb Incorporated

Rochester, New York, 14609, United States

Limitations and Caveats

A single randomization schedule was produced before enrollment. It specified one presentation order - kalifilcon A, then Dailies Total1, then Precision1 (applied to every participant). The randomization determined the order itself; it did not allocate participants between different sequences. Unworn (baseline) surface refractive index values were not measured concurrently within this study. They were measured on 10 unworn lenses of each type in study ROC2-20-012.

Results Point of Contact

Title: Jeffery Schafer, Director Clinical Research
Organization: Bausch & Lomb Incorporated

Study Officials

Jeffery Schafer, OD, MS
Bausch & Lomb Incorporated
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

10 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Masking Details: Participants and the Investigator were masked to the identity of the lens type worn at each visit. Unmasked study personnel, not otherwise involved in assessment, dispensed and collected the study lenses and maintained lens accountability. Because every participant wore all three lens types in the same presentation order, there was no masked assignment of participants to different arms.
Purpose: BASIC SCIENCE
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 7, 2021

First Posted

April 12, 2021

Study Start

Surface Refractive Index Shift of Kalifilcon A Compared With Dailies Total1 and Precision1 Lenses

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

All Participants: kalifilcon A, Then Dailies Total1, Then Precision1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

All Participants: kalifilcon A, Then Dailies Total1, Then Precision1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations