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NCT03897712 · ClinicalTrials.gov registry record · NA
A Study to Evaluate the Safety and Effectiveness of a Silicone Hydrogel Custom Contact Lens When Compared to Alden Optical HP Sphere Lens
A NA study, sponsored by Bausch & Lomb Incorporated.
- Completed
- Registry status
- NA
- Development phase
- 84
- Enrollment target
NCT03897712: Completed NA study, sponsored by Bausch & Lomb Incorporated.
NCT03897712 is a NA study that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 84 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03897712, a NA study, has completed, sponsored by Bausch & Lomb Incorporated.
- COMPLETED
- Registry status
- NA
- Development phase
- 84 participants
- Enrollment target
Study Summary
This study is to evaluate the safety and efficacy of Bausch + Lomb custom samfilcon B (test) lens compared to the hioxifilcon D, 54% water, Alden Optical HP Sphere (control) lens when worn by participants who wear soft contact lens on a daily basis.
Primary Outcome
Monocular distance high-contrast logarithm of the minimum angle of resolution (logMAR) lens visual acuity (VA) will be assessed at Week 1, Month 1, Month 2, and Month. For each eye LogMAR will be averaged at Week 1, Month 1, Month 2, and Month 3 visits, resulting in 1 value of "All Study" logMAR lens VA per eye.
Interventions
- DEVICE Custom Samfilcon B Contact Lenses
- DEVICE Alden Optical HP Sphere Contact Lens
- DEVICE ReNu MultiPlus Lubricating and Rewetting Drops
- DEVICE Biotrue Multi-Purpose Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2019-02-27 |
| Est. Completion | 2019-08-28 |
| Phase | NA |
What the finished NCT03897712 record still lists
NCT03897712 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 4 interventions - of which Custom Samfilcon B Contact Lenses is the first listed.
NCT03897712 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03897712 about?
NCT03897712 is a clinical study titled "A Study to Evaluate the Safety and Effectiveness of a Silicone Hydrogel Custom Contact Lens When Compared to Alden Optical HP Sphere Lens". This study is to evaluate the safety and efficacy of Bausch + Lomb custom samfilcon B (test) lens compared to the hioxifilcon D, 54% water, Alden Optical HP Sphere (control) lens when worn by participants who wear soft contact lens on a daily basis.
What is the current status of trial NCT03897712?
This trial is currently completed. It is a NA study. The enrollment target is 84 participants. The study started on 2019-02-27. Estimated completion is 2019-08-28.
What interventions are being tested in trial NCT03897712?
The interventions under investigation include: Custom Samfilcon B Contact Lenses (DEVICE), Alden Optical HP Sphere Contact Lens (DEVICE), ReNu MultiPlus Lubricating and Rewetting Drops (DEVICE), Biotrue Multi-Purpose Solution (DEVICE).
Who is sponsoring clinical trial NCT03897712?
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 NCT03897712's enrollment target sits among peer trials
84 983rd of 2000 higher than 1,011 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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