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NCT04085328 · ClinicalTrials.gov registry record · NA
Assessment of an Investigational Frequent Replacement Silicone Hydrogel Lens
A NA study of Refractive Ametropia, sponsored by Alcon Research.
- Completed
- Registry status
- NA
- Development phase
- 675
- Enrollment target
- 20
- Study locations
NCT04085328: Completed NA study of Refractive Ametropia, sponsored by Alcon Research.
NCT04085328 is a NA study of Refractive Ametropia that has completed, run by Alcon Research. The registered enrollment target is 675 participants, above the 100-participant average among 5 other Refractive Ametropia trials with a reported enrollment target (575% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04085328, a NA study of Refractive Ametropia, has completed, sponsored by Alcon Research.
- COMPLETED
- Registry status
- NA
- Development phase
- 675 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this clinical trial is to evaluate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in an extended wear modality.
Primary Outcome
Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was perf
Conditions Studied
Interventions
- DEVICE LID015385 soft contact lenses
- DEVICE Comfilcon A soft contact lenses
Study Locations (20)
California
- Family EyeCare Center - Campbell
- Winston Eye Care - Fullerton
- Kurata Eye Care Center - Los Angeles
- East West Eye Institute - Los Angeles
- Dr.Elsa Pao, O.D - Oakland
- Gordon Schanzlin New Vision Institute - San Diego
- Complete Family Vision Care - San Diego
- Westview Optometry - San Diego
Florida
- OMEGA Vision Center PA, DBA Sabal Eye Care - Longwood
- Kindred Optics at Maitland Vision Center - Maitland
- Mid Florida Eye Center, PA - Mt. Dora
- Eola Eyes - Orlando
- Vision Health Institute - Orlando
- Visual Performance Center Research & Development - Pensacola
- Golden Vision - Sarasota
- Advanced Eyecare Specialists - West Palm Beach
Illinois
- VisionPoint Eye Center - Bloomington
- Franklin Park Eye Center, PC - Franklin Park
Kansas
- Kannarr Eye Care, LLC - Pittsburg
Massachusetts
- Optimum Vision Care - Brighton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 675 participants |
| Start Date | 2019-10-11 |
| Est. Completion | 2021-03-26 |
| Phase | NA |
What the finished NCT04085328 record still lists
NCT04085328 is an interventional study that assigns participants to a tested intervention. The registered 675 participants enrollment target is mid-sized for trials with a published cap, above the 100-participant average among 5 other Refractive Ametropia trials with a reported enrollment target (575% higher).
The record links to 1 condition, with Refractive Ametropia appearing as the primary indexed condition, and to 2 interventions - of which LID015385 soft contact lenses is the first listed.
NCT04085328 names 20 study sites across 5 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT04085328 about?
NCT04085328 is a clinical study titled "Assessment of an Investigational Frequent Replacement Silicone Hydrogel Lens". The purpose of this clinical trial is to evaluate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in an extended wear modality.
What is the current status of trial NCT04085328?
This trial is currently completed. It is a NA study. The enrollment target is 675 participants. The study started on 2019-10-11. Estimated completion is 2021-03-26.
What conditions does trial NCT04085328 study?
This clinical trial studies the following conditions: Refractive Ametropia.
What interventions are being tested in trial NCT04085328?
The interventions under investigation include: LID015385 soft contact lenses (DEVICE), Comfilcon A soft contact lenses (DEVICE).
Who is sponsoring clinical trial NCT04085328?
This trial is sponsored by Alcon Research, which has 275 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04085328 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Kansas, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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