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NCT00766168 · ClinicalTrials.gov registry record · NA
High Refractive Index Material 510(k)
A NA study, sponsored by CooperVision International Limited (CVIL).
- Completed
- Registry status
- NA
- Development phase
- 76
- Enrollment target
NCT00766168: Completed NA study, sponsored by CooperVision International Limited (CVIL).
NCT00766168 is a NA study that has completed, run by CooperVision International Limited (CVIL). The registered enrollment target is 76 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00766168, a NA study, has completed, sponsored by CooperVision International Limited (CVIL).
- COMPLETED
- Registry status
- NA
- Development phase
- 76 participants
- Enrollment target
Study Summary
The purpose of this study is to establish the substantial equivalence of the HDS HI 1.54™ to the paflufocon C material control lenses to correct myopia and hyperopia with and without astigmatism. The purpose of the study is to profile the outcome endpoints and the patient acceptance of this Class II medical device.
Primary Outcome
Of the 72 Completed Test eyes, seven (7) eyes were reported to show a decrease in visual acuity of greater than 0.20 logMAR of which six (6) eyes were for a targeted monovision near power. Of the 56 Completed Control eyes eight (8) eyes were reported to show a decrease in visual acuity of greater than 0.20 logMAR of which seven (7) eyes were for a targeted monovision near power. The reasons cited for the decrease of the remaining Test eye was a reported baseline measurement error and for the rem
Interventions
- OTHER HDS HI 1.54; pahrifocon A
- DEVICE FluoroPerm 30 RGP; paflufocon C
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2008-01 |
| Est. Completion | 2008-08 |
| Phase | NA |
What the finished NCT00766168 record still lists
NCT00766168 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which HDS HI 1.54; pahrifocon A is the first listed.
NCT00766168 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00766168 about?
NCT00766168 is a clinical study titled "High Refractive Index Material 510(k)". The purpose of this study is to establish the substantial equivalence of the HDS HI 1.54™ to the paflufocon C material control lenses to correct myopia and hyperopia with and without astigmatism. The purpose of the study is to profile the outcome endpoints and the patient acceptance of this Class II...
What is the current status of trial NCT00766168?
This trial is currently completed. It is a NA study. The enrollment target is 76 participants. The study started on 2008-01. Estimated completion is 2008-08.
What interventions are being tested in trial NCT00766168?
The interventions under investigation include: HDS HI 1.54; pahrifocon A (OTHER), FluoroPerm 30 RGP; paflufocon C (DEVICE).
Who is sponsoring clinical trial NCT00766168?
This trial is sponsored by CooperVision International Limited (CVIL), which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00766168's enrollment target sits among peer trials
76 1062nd of 2000 higher than 932 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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