CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 84 enrolled
Drug / intervention
Custom Samfilcon B Contact 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/NCT03897712
NCT03897712N/ACompleted
CompareCT.gov

A Study to Evaluate the Safety and Effectiveness of a Silicone Hydrogel Custom Contact Lens

Bausch & Lomb Incorporated·interventional·Posted Apr 1, 2019·Updated Nov 14, 2022

In Brief

A clinical study evaluating Custom Samfilcon B Contact Lenses, Alden Optical HP Sphere Contact Lens, and 2 other interventions for Contact Lens Wear. Completed, enrolled 84 participants across 7 sites.

Detailed Summary

This study is to evaluate the safety and efficacy of Bausch + Lomb custom samfilcon B (test) lens compared to the hioxifilcon D, 54% water, Alden Optical HP Sphere (control) lens when worn by participants who wear soft contact lens on a daily basis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsContact Lens Wear
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedApr 1, 2019
Enrollment StartFeb 27, 2019
Primary CompletionAug 28, 2019
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 7.3 years ago

Interventions

Custom Samfilcon B Contact Lensesdevice

Contact lens

Alden Optical HP Sphere Contact Lensdevice

Hioxifilcon D, 54% water, Alden Optical HP Sphere lens

ReNu MultiPlus Lubricating and Rewetting Dropsdevice

For use as needed during the study.

Biotrue Multi-Purpose Solutiondevice

For daily rinsing, cleaning, disinfecting, and storing their lenses in lens cases during the study.