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NCT03971227 · ClinicalTrials.gov registry record · NA
Clinical Evaluation of Acuity 200 (Fluoroxyfocon A) RGP Contact Lens
A NA study, sponsored by Acuity Polymers.
- Completed
- Registry status
- NA
- Development phase
- 74
- Enrollment target
NCT03971227: Completed NA study, sponsored by Acuity Polymers.
NCT03971227 is a NA study that has completed, run by Acuity Polymers. The registered enrollment target is 74 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03971227, a NA study, has completed, sponsored by Acuity Polymers.
- COMPLETED
- Registry status
- NA
- Development phase
- 74 participants
- Enrollment target
Study Summary
The objective of this clinical investigation is to collect valid scientific safety and effectiveness data on the Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens, manufactured from a newly developed rigid gas permeable material that is highly permeable to oxygen. The clinical performance data reported from this study is intended to be submitted to the U.S. Food and Drug Administration Center for Devices and Radiological Health (CDRH) in support of a 510(k) premarket notification.
Primary Outcome
Comparison of the corrected visual acuity (logMAR) between the Test and Control lens. The working hypothesis is that the visual acuity results will be substantially equivalent between the Test and the Control lenses.
Interventions
- DEVICE Acuity 200 (Fluoroxyfocon A) contact lens
- DEVICE Acuity 100 (Hexafocon A) contact lens
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2019-04-01 |
| Est. Completion | 2020-03-19 |
| Phase | NA |
What the finished NCT03971227 record still lists
NCT03971227 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Acuity 200 (Fluoroxyfocon A) contact lens is the first listed.
NCT03971227 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03971227 about?
NCT03971227 is a clinical study titled "Clinical Evaluation of Acuity 200 (Fluoroxyfocon A) RGP Contact Lens". The objective of this clinical investigation is to collect valid scientific safety and effectiveness data on the Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens, manufactured from a newly developed rigid gas permeable material that is highly permeable to oxygen. The clinical performanc...
What is the current status of trial NCT03971227?
This trial is currently completed. It is a NA study. The enrollment target is 74 participants. The study started on 2019-04-01. Estimated completion is 2020-03-19.
What interventions are being tested in trial NCT03971227?
The interventions under investigation include: Acuity 200 (Fluoroxyfocon A) contact lens (DEVICE), Acuity 100 (Hexafocon A) contact lens (DEVICE).
Who is sponsoring clinical trial NCT03971227?
This trial is sponsored by Acuity Polymers, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03971227's enrollment target sits among peer trials
74 1082nd of 2000 higher than 912 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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