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NCT04175340 · ClinicalTrials.gov registry record · NA
A Safety and Effectiveness Study of a New Preservative Free Rewetting Drop
A NA study of Contact Lens Wear, sponsored by Bausch & Lomb Incorporated.
- Completed
- Registry status
- NA
- Development phase
- 369
- Enrollment target
- 15
- Study locations
NCT04175340: Completed NA study of Contact Lens Wear, sponsored by Bausch & Lomb Incorporated.
NCT04175340 is a NA study of Contact Lens Wear that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 369 participants, above the 294-participant average among 3 other Contact Lens Wear trials with a reported enrollment target (26% higher). The trial reports 15 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04175340, a NA study of Contact Lens Wear, has completed, sponsored by Bausch & Lomb Incorporated.
- COMPLETED
- Registry status
- NA
- Development phase
- 369 participants
- Enrollment target
- 15
- Study locations
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.
Primary Outcome
Overall comfort will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response. For each eye, mean overall comfort over all follow-up visits will be computed as the average of the non-missing values overall scheduled follow-up visits.
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
| Field | Value |
|---|---|
| Enrollment Target | 369 participants |
| Start Date | 2019-11-07 |
| Est. Completion | 2020-02-17 |
| Phase | NA |
What the finished NCT04175340 record still lists
NCT04175340 is an interventional study that assigns participants to a tested intervention. The registered 369 participants enrollment target is mid-sized for trials with a published cap, above the 294-participant average among 3 other Contact Lens Wear trials with a reported enrollment target (26% higher).
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.
NCT04175340 lists 15 locations in 10 states (California, Kansas, New York).
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.
What interventions are being tested in trial NCT04175340?
The interventions under investigation include: BL-300-PFM04 (DEVICE), OPTI-FREE (DEVICE).
Who is sponsoring clinical trial NCT04175340?
This trial is sponsored by Bausch & Lomb Incorporated, which has 174 total clinical trials registered on ClinicalTrials.gov.
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.
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