High Refractive Index Material 510(k)
PVS-07-07
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.
2 other identifiers
interventional
76
1 country
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2008
Shorter than P25 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 1, 2008
CompletedFirst Posted
Study publicly available on registry
October 3, 2008
CompletedJune 14, 2012
June 1, 2012
7 months
October 1, 2008
June 12, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Best Corrected Visual Acuity vs Control
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 remaining Control eye was lenses being switched eye for eye.
3 months
Secondary Outcomes (2)
Incidence of problems , symptoms and complaints vs control
3 months
slit lamp observations greater than grade 3
3 months
Study Arms (2)
Control
ACTIVE COMPARATORFluoroPerm 30 RGP lens daily wear
HDS HI 1.54
EXPERIMENTALNew rigid gas permeable contact lens material material
Interventions
Eligibility Criteria
You may qualify if:
- Subjects may be male or female, of any race, and at least 12 years old at the time of the pre-treatment examination.
- The prospective eye(s) must have naturally occurring refractive myopia up to -20.00 D or hyperopia or aphakia up to +20.00 D sphere (spectacle plane), with less than 10.00 D of refractive astigmatism (spectacle plane), as determined by manifest refraction (phoropter or trial frame with a 12.5 mm vertex distance). Subjects must have best spectacle corrected visual acuity of at least 0.30 logMAR (20/40) in each eye.
- All subjects must be treated bilaterally.
- Subjects must be willing and capable to return for all scheduled follow-up visits for a period of at least 3 months.
You may not qualify if:
- Female subjects who are pregnant, breast-feeding or intend to become pregnant over the course of the study.
- Subjects with a history of any of the following medical conditions: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to active thyroid disorders and diabetes), lupus, and rheumatoid arthritis.
- NOTE: The presence of diabetes (either type 1 or 2), regardless of disease duration, severity or control, will specifically exclude subjects from eligibility.
- Subjects with a history of intraocular or corneal surgery (excluding cataract extraction and refractive surgery), active ophthalmic disease or abnormality (including, but not limited to, blepharitis, recurrent corneal erosion, dry eye syndrome, neovascularization \> 1mm from limbus), clinically significant lens opacity, clinical evidence of trauma (including scarring), or with evidence of glaucoma or propensity for narrow angle glaucoma as determined by gonioscopic examination in either eye.
- NOTE: This includes any patient with open angle glaucoma, regardless of medication regimen or control. Additionally, any patient with an IOP greater than 21 mm Hg at baseline is specifically excluded from eligibility.
- Subjects with evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye.
- Subjects who are participating in any other clinical trial (FDA or other).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Mission Optometry
Lake Elsinore, California, 92530, United States
Eyecare Consultants
Englewood, Colorado, 80112, United States
Vision Care Associates
East Lansing, Michigan, 48823, United States
Koetting Associates
St Louis, Missouri, 63144, United States
Visionary Eye Associates
Rochester, New York, 14618, United States
Western Reserve Vision Care
Beachwood, Ohio, 44122, United States
Choate Eye Associates
Goodlettsville, Tennessee, 37072, United States
Twin Lakes Vision Clinic
Federal Way, Washington, 98023, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jerome A. Legerton, OD, MS
Consultant to Paragon Vision Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2008
First Posted
October 3, 2008
Study Start
January 1, 2008
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
June 14, 2012
Record last verified: 2012-06