CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 369 enrolled
Drug / intervention
BL-300-PFM04 +1 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/NCT04175340
NCT04175340N/ACompleted

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

Bausch & Lomb Incorporated·interventional·Posted Nov 25, 2019·Updated Jul 10, 2024

In Brief

A clinical study evaluating BL-300-PFM04 and OPTI-FREE for Contact Lens Wear. Completed, enrolled 369 participants across 15 sites.

Detailed 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.

Study Details

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

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedNov 25, 2019
Enrollment StartNov 7, 2019
Primary CompletionFeb 17, 2020
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 6.6 years ago

Interventions

BL-300-PFM04device

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

OPTI-FREEdevice

Replenish Rewetting Drops