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NCT01391364 · ClinicalTrials.gov registry record · NA
A Study to Evaluate a Modified Contact Lens
A NA study, sponsored by Bausch & Lomb Incorporated.
- Completed
- Registry status
- NA
- Development phase
- 438
- Enrollment target
NCT01391364: Completed NA study, sponsored by Bausch & Lomb Incorporated.
NCT01391364 is a NA study that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 438 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01391364, a NA study, has completed, sponsored by Bausch & Lomb Incorporated.
- COMPLETED
- Registry status
- NA
- Development phase
- 438 participants
- Enrollment target
Study Summary
This study is being conducted to evaluate the product performance of SofLens daily disposable contact lenses packaged in an investigational Test solution versus SofLens daily disposable contact lenses packaged in the currently marketed solution (Control), as it relates to comfort when worn by adapted soft contact lens wearers on a daily-wear basis.
Primary Outcome
Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding \> grade 2, across abnormalities.
Interventions
- DEVICE SofLens in investigational solution
- DEVICE SofLens in currently marketed solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 438 participants |
| Start Date | 2011-04 |
| Est. Completion | 2011-07 |
| Phase | NA |
What the finished NCT01391364 record still lists
NCT01391364 is an interventional study that assigns participants to a tested intervention. The registered 438 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 2 interventions - of which SofLens in investigational solution is the first listed.
NCT01391364 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01391364 about?
NCT01391364 is a clinical study titled "A Study to Evaluate a Modified Contact Lens". This study is being conducted to evaluate the product performance of SofLens daily disposable contact lenses packaged in an investigational Test solution versus SofLens daily disposable contact lenses packaged in the currently marketed solution (Control), as it relates to comfort when worn by adapte...
What is the current status of trial NCT01391364?
This trial is currently completed. It is a NA study. The enrollment target is 438 participants. The study started on 2011-04. Estimated completion is 2011-07.
What interventions are being tested in trial NCT01391364?
The interventions under investigation include: SofLens in investigational solution (DEVICE), SofLens in currently marketed solution (DEVICE).
Who is sponsoring clinical trial NCT01391364?
This trial is sponsored by Bausch & Lomb Incorporated, which has 174 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01391364's enrollment target sits among peer trials
438 235th of 2000 higher than 1,766 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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