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A Study to Evaluate the Safety and Effectiveness of a Silicone Hydrogel Custom Contact Lens When Compared to Alden Optical HP Sphere Lens

NCT03897712 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2022-11-14

Study results available
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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.

Conditions

  • Contact Lens Wear

Interventions

DEVICE

Custom Samfilcon B Contact Lenses

Contact lens

DEVICE

Alden Optical HP Sphere Contact Lens

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

DEVICE

ReNu MultiPlus Lubricating and Rewetting Drops

For use as needed during the study.

DEVICE

Biotrue Multi-Purpose Solution

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

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Principal Investigators

  • Johnson Varughese · Bausch & Lomb Incorporated

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-27
Primary Completion
2019-08-28
Completion
2019-08-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03897712 on ClinicalTrials.gov