High Refractive Index Material 510(k)
Public ClinicalTrials.gov record NCT00766168. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Prospective Study of Substantial Equivalence of Rigid Gas Permeable HDS HI 1.54™ Daily Wear Lenses for Correction of Naturally Occurring Myopia and Hyperopia From +20 to - 20 D Sphere (Spectacle Plane) With and Without Astigmatism.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00766168
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 76 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 2008 (Type not available)
- Primary completion
- Aug 2008 (Actual)
- Completion
- Aug 2008 (Actual)
- Last update posted
- Jun 14, 2012
2008
United States locations
- U.S. sites
- 8
- U.S. states
- 8
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mission Optometry | Lake Elsinore | California | 92530 | — |
| Eyecare Consultants | Englewood | Colorado | 80112 | — |
| Vision Care Associates | East Lansing | Michigan | 48823 | — |
| Koetting Associates | St Louis | Missouri | 63144 | — |
| Visionary Eye Associates | Rochester | New York | 14618 | — |
| Western Reserve Vision Care | Beachwood | Ohio | 44122 | — |
| Choate Eye Associates | Goodlettsville | Tennessee | 37072 | — |
| Twin Lakes Vision Clinic | Federal Way | Washington | 98023 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00766168, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 14, 2012 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00766168 live on ClinicalTrials.gov.