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NCT04158466 · ClinicalTrials.gov registry record · NA
A Study to Evaluate the Safety and Efficacy of Kalifilcon A Daily Disposable Contact Lens
A NA study of Contact Lens Wear, sponsored by Bausch & Lomb Incorporated.
- Completed
- Registry status
- NA
- Development phase
- 252
- Enrollment target
- 16
- Study locations
NCT04158466: Completed NA study of Contact Lens Wear, sponsored by Bausch & Lomb Incorporated.
NCT04158466 is a NA study of Contact Lens Wear that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 252 participants, below the 333-participant average among 3 other Contact Lens Wear trials with a reported enrollment target (24% lower). The trial reports 16 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04158466, a NA study of Contact Lens Wear, has completed, sponsored by Bausch & Lomb Incorporated.
- COMPLETED
- Registry status
- NA
- Development phase
- 252 participants
- Enrollment target
- 16
- Study locations
Study Summary
This study is to evaluate the safety and efficacy of a new silicone hydrogel daily disposable contact lens, kalifilcon A compared to the Bausch + Lomb Biotrue ONE day® daily disposable contact lens when worn by current soft contact lens wearers on a daily disposable wear basis.
Primary Outcome
Visual acuity (VA) will be reported as letters read correctly, and the letters read will be converted to logarithm of the minimum angle of resolution (logMAR) acuity. The participant will read rows of letters on a standard LogMAR chart until the participant misses 3 letters on a row with 5 letters. The total number of correct letters will be recorded. A decrease in the number of correct letters indicates a decrease in visual acuity. Acuity will be averaged across visits.
Conditions Studied
Interventions
- DEVICE Kalifilcon A Daily Disposable Contact Lenses
- DEVICE Biotrue ONEday Daily Disposable Contact Lenses
Study Locations (16)
California
- Bausch Site 8 - Los Angeles
- Bausch Site 9 - San Francisco
- Bausch Site 10 - Torrance
- Bausch Site 12 - Torrance
Tennessee
- Bausch Site 14 - Brentwood
- Bausch Site 5 - Memphis
- Bausch Site 3 - Nashville
Hawaii
- Bausch Site 16 - Honolulu
- Bausch Site 4 - ‘Aiea
Florida
- Bausch Site 6 - Sarasota
Kansas
- Bausch Site 7 - Pittsburg
Minnesota
- Bausch Site 11 - Bloomington
Missouri
- Bausch Site 1 - St Louis
New York
- Bausch Site 13 - Vestal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 252 participants |
| Start Date | 2019-05-31 |
| Est. Completion | 2019-11-12 |
| Phase | NA |
What the finished NCT04158466 record still lists
NCT04158466 is an interventional study that assigns participants to a tested intervention. The registered 252 participants enrollment target is mid-sized for trials with a published cap, below the 333-participant average among 3 other Contact Lens Wear trials with a reported enrollment target (24% lower).
The record links to 1 condition, with Contact Lens Wear appearing as the primary indexed condition, and to 2 interventions - of which Kalifilcon A Daily Disposable Contact Lenses is the first listed.
NCT04158466 lists 16 locations in 10 states (California, Tennessee, Hawaii).
Frequently Asked Questions
What is clinical trial NCT04158466 about?
NCT04158466 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Kalifilcon A Daily Disposable Contact Lens". This study is to evaluate the safety and efficacy of a new silicone hydrogel daily disposable contact lens, kalifilcon A compared to the Bausch + Lomb Biotrue ONE day® daily disposable contact lens when worn by current soft contact lens wearers on a daily disposable wear basis.
What is the current status of trial NCT04158466?
This trial is currently completed. It is a NA study. The enrollment target is 252 participants. The study started on 2019-05-31. Estimated completion is 2019-11-12.
What conditions does trial NCT04158466 study?
This clinical trial studies the following conditions: Contact Lens Wear.
What interventions are being tested in trial NCT04158466?
The interventions under investigation include: Kalifilcon A Daily Disposable Contact Lenses (DEVICE), Biotrue ONEday Daily Disposable Contact Lenses (DEVICE).
Who is sponsoring clinical trial NCT04158466?
This trial is sponsored by Bausch & Lomb Incorporated, which has 174 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04158466 being conducted?
This trial has 16 study locations across California, Florida, Hawaii, Kansas, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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