CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
kalifilcon A lenses +3 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04555031
NCT04555031N/ACompleted

Evaluation of Surface Refractive Index Shift of Kalifilcon A Lenses Compared to Dailies Total 1, Precision 1 and Biotrue ONEday Lenses

Bausch & Lomb Incorporated·interventional·Posted Sep 18, 2020·Updated Nov 8, 2021

In Brief

A clinical study evaluating kalifilcon A lenses, Dalies Total 1, and 2 other interventions for Habitual Soft Contact Lens Use. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedSep 18, 2020
Enrollment StartSep 9, 2020
Primary CompletionSep 16, 2020
TodayJul 2, 2026
Enrollment to primary: 7 daysPosted 5.8 years ago

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.

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.

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.

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.