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A Safety and Effectiveness Study of a New Preservative Free Rewetting Drop

NCT04175340 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 369

Last updated 2024-07-10

Study results available
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Summary

The objective of this study is to evaluate the safety and effectiveness of lubricating and rewetting drop (Test) compared to OPTI-FREE® Replenish® Rewetting Drops (Control) when used by habitual contact lens wearers to bilaterally lubricate and rewet soft (hydrophilic) contact lenses including silicone hydrogel contact lenses and gas permeable (silicone acrylate and fluoro silicone acrylate) contact lenses.

Conditions

  • Contact Lens Wear

Interventions

DEVICE

BL-300-PFM04

Preservative Free Lubricating and Rewetting Drops for use during contact lens wear

DEVICE

OPTI-FREE

Replenish Rewetting Drops

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-07
Primary Completion
2020-02-17
Completion
2020-02-17
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 NCT04175340 on ClinicalTrials.gov