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COMPLETED NA

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

NCT04175340 · View on ClinicalTrials.gov ↗

Study 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 Studied

Interventions

  • DEVICE BL-300-PFM04
  • DEVICE OPTI-FREE

Study Locations (15)

California

  • Bausch Site 108 — San Francisco
  • Bausch Site 111 — Torrance

Kansas

  • Bausch Site 110 — Bloomington
  • Bausch Site 112 — Leavenworth

New York

  • Bausch Site 102 — Jamestown
  • Bausch Site 113 — Vestal

Ohio

  • Bausch Site 101 — Miamisburg
  • Bausch Site 105 — West Chester

Tennessee

  • Bausch Site 115 — Brentwood
  • Bausch Site 103 — Nashville

Florida

  • Bausch Site 106 — Sarasota

Georgia

  • Bausch Site 104 — Decatur

Maine

  • Bausch Site 107 — Portland

Trial Details

FieldValue
Enrollment Target 369 participants
Start Date 2019-11-07
Est. Completion 2020-02-17
Phase NA

Sponsor

Bausch & Lomb Incorporated

78 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04175340

The ClinicalTrials.gov registry entry for NCT04175340 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 369 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch & Lomb Incorporated, which has 78 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Contact Lens Wear appearing as the primary indexed condition, and to 2 interventions — of which BL-300-PFM04 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04175340 reports 15 study locations spanning 10 distinct geographic areas — top geographies include California, Kansas, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04175340 about?

NCT04175340 is a clinical study titled "A Safety and Effectiveness Study of a New Preservative Free Rewetting Drop". 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 silic...

What is the current status of trial NCT04175340?

This trial is currently completed. It is a NA study. The enrollment target is 369 participants. The study started on 2019-11-07. Estimated completion is 2020-02-17.

What conditions does trial NCT04175340 study?

This clinical trial studies the following conditions: Contact Lens Wear. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04175340?

The interventions under investigation include: BL-300-PFM04 (DEVICE), OPTI-FREE (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04175340?

This trial is sponsored by Bausch & Lomb Incorporated, which has 78 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04175340 being conducted?

This trial has 15 study locations across California, Florida, Georgia, Kansas, Maine. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial