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NCT01484054 · ClinicalTrials.gov registry record · NA
Dispensing Evaluation of Subjective Comfort, Vision, and Handling of a New Lens Compared to a Marketed Lens
A NA study of Refractive Ametropia, sponsored by Johnson & Johnson Vision Care.
- Completed
- Registry status
- NA
- Development phase
- 103
- Enrollment target
- 6
- Study locations
NCT01484054: Completed NA study of Refractive Ametropia, sponsored by Johnson & Johnson Vision Care.
NCT01484054 is a NA study of Refractive Ametropia that has completed, run by Johnson & Johnson Vision Care. The registered enrollment target is 103 participants, below the 214-participant average among 5 other Refractive Ametropia trials with a reported enrollment target (52% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01484054, a NA study of Refractive Ametropia, has completed, sponsored by Johnson & Johnson Vision Care.
- COMPLETED
- Registry status
- NA
- Development phase
- 103 participants
- Enrollment target
- 6
- Study locations
Study Summary
To evaluate and compare the performance of a new contact lens to a marketed contact lens.
Primary Outcome
The overall quality of lens vision was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range from 0-120.
Conditions Studied
Interventions
- DEVICE etafilcon A with print and PVP for dark eyes (EAPVPDE)
- DEVICE etafilcon A control lens (EADE)
Study Locations (6)
Pennsylvania
- - Kingston
- - Moon Township
Connecticut
- - Bloomfield
Florida
- - Tallahassee
Kansas
- - Overland Park
New York
- - Jamestown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2011-11 |
| Est. Completion | 2012-02 |
| Phase | NA |
What the finished NCT01484054 record still lists
NCT01484054 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 214-participant average among 5 other Refractive Ametropia trials with a reported enrollment target (52% lower).
The record links to 1 condition, with Refractive Ametropia appearing as the primary indexed condition, and to 2 interventions - of which etafilcon A with print and PVP for dark eyes (EAPVPDE) is the first listed.
NCT01484054 lists 6 locations in 5 states (Pennsylvania, Connecticut, Florida).
Frequently Asked Questions
What is clinical trial NCT01484054 about?
NCT01484054 is a clinical study titled "Dispensing Evaluation of Subjective Comfort, Vision, and Handling of a New Lens Compared to a Marketed Lens". To evaluate and compare the performance of a new contact lens to a marketed contact lens.
What is the current status of trial NCT01484054?
This trial is currently completed. It is a NA study. The enrollment target is 103 participants. The study started on 2011-11. Estimated completion is 2012-02.
What conditions does trial NCT01484054 study?
This clinical trial studies the following conditions: Refractive Ametropia.
What interventions are being tested in trial NCT01484054?
The interventions under investigation include: etafilcon A with print and PVP for dark eyes (EAPVPDE) (DEVICE), etafilcon A control lens (EADE) (DEVICE).
Who is sponsoring clinical trial NCT01484054?
This trial is sponsored by Johnson & Johnson Vision Care, which has 142 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01484054 being conducted?
This trial has 6 study locations across Connecticut, Florida, Kansas, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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