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NCT03537248 · ClinicalTrials.gov registry record · NA
A Safety and Effectiveness Study of a New Multi-Purpose Contact Lens Care Solution
A NA study of Contact Lens Wear, sponsored by Asepticys.
- Completed
- Registry status
- NA
- Development phase
- 315
- Enrollment target
- 14
- Study locations
NCT03537248: Completed NA study of Contact Lens Wear, sponsored by Asepticys.
NCT03537248 is a NA study of Contact Lens Wear that has completed, run by Asepticys. The registered enrollment target is 315 participants, roughly in line with the 312-participant average among 3 other Contact Lens Wear trials with a reported enrollment target. The trial reports 14 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03537248, a NA study of Contact Lens Wear, has completed, sponsored by Asepticys.
- COMPLETED
- Registry status
- NA
- Development phase
- 315 participants
- Enrollment target
- 14
- Study locations
Study Summary
The objective of this study is to evaluate the safety and effectiveness of ASP-57 Multi-Purpose contact lens solution (Test) compared to ReNu® Multiplus Contact Lens Solution (Control) when used by habitual contact lens wearers to bilaterally clean and disinfect their contact lenses for approximately 3 months (12 weeks).
Primary Outcome
Statistical non-inferiority with respect to the proportion of eyes with any slit-lamp findings greater than Grade 2 at any visit between the test and control solutions
Conditions Studied
Interventions
- DEVICE ASP-57
- DEVICE ReNu® Multiplus
Study Locations (14)
Florida
- Sabal Eye Care - Longwood
- Maitland Vision Center - Maitland
- Vision Health Institute - Orlando
California
- Lakeside Vision Center - Irvine
- Complete Family Vision Care - San Diego
Kansas
- Kannarr Eye Care - Pittsburg
- Heart of America Eye Care - Shawnee Mission
Tennessee
- Optometry Group - Memphis
- Optique Eyecare - Nashville
Illinois
- Eye Care Associates - Bloomington
Maryland
- Seidenberg Protzko Eye Associates - Havre de Grace
Missouri
- Insight Eyecare - Warrensburg
Ohio
- Drs Quinn, Foster & Associates - Athens
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 315 participants |
| Start Date | 2018-04-23 |
| Est. Completion | 2018-10-30 |
| Phase | NA |
What the finished NCT03537248 record still lists
NCT03537248 is an interventional study that assigns participants to a tested intervention. The registered 315 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 312-participant average among 3 other Contact Lens Wear trials with a reported enrollment target.
The record links to 1 condition, with Contact Lens Wear appearing as the primary indexed condition, and to 2 interventions - of which ASP-57 is the first listed.
NCT03537248 lists 14 locations in 9 states (Florida, California, Kansas).
Frequently Asked Questions
What is clinical trial NCT03537248 about?
NCT03537248 is a clinical study titled "A Safety and Effectiveness Study of a New Multi-Purpose Contact Lens Care Solution". The objective of this study is to evaluate the safety and effectiveness of ASP-57 Multi-Purpose contact lens solution (Test) compared to ReNu® Multiplus Contact Lens Solution (Control) when used by habitual contact lens wearers to bilaterally clean and disinfect their contact lenses for approximatel...
What is the current status of trial NCT03537248?
This trial is currently completed. It is a NA study. The enrollment target is 315 participants. The study started on 2018-04-23. Estimated completion is 2018-10-30.
What conditions does trial NCT03537248 study?
This clinical trial studies the following conditions: Contact Lens Wear.
What interventions are being tested in trial NCT03537248?
The interventions under investigation include: ASP-57 (DEVICE), ReNu® Multiplus (DEVICE).
Who is sponsoring clinical trial NCT03537248?
This trial is sponsored by Asepticys, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03537248 being conducted?
This trial has 14 study locations across California, Florida, Illinois, Kansas, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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