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High Refractive Index Material 510(k) (PVS-07-07)

Primary Purpose

Myopia, Hyperopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HDS HI 1.54; pahrifocon A
FluoroPerm 30 RGP; paflufocon C
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring contact lens, rigid gas permeable, refractive index

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Subjects may be male or female, of any race, and at least 12 years old at the time of the pre-treatment examination.
  2. 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.
  3. All subjects must be treated bilaterally.
  4. Subjects must be willing and capable to return for all scheduled follow-up visits for a period of at least 3 months.

Exclusion Criteria:

  1. Female subjects who are pregnant, breast-feeding or intend to become pregnant over the course of the study.
  2. 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.

  3. 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.

  4. Subjects with evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye.
  5. Subjects who are participating in any other clinical trial (FDA or other).

Sites / Locations

  • Mission Optometry
  • Eyecare Consultants
  • Vision Care Associates
  • Koetting Associates
  • Visionary Eye Associates
  • Western Reserve Vision Care
  • Choate Eye Associates
  • Twin Lakes Vision Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

HDS HI 1.54

Arm Description

FluoroPerm 30 RGP lens daily wear

New rigid gas permeable contact lens material material

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Incidence of problems , symptoms and complaints vs control
For the Completed Test eyes, no symptoms were reported for 23.0% (107/466) of the eye symptom reports after the baseline visit. For the Completed Control eyes, no symptoms were reported for 28.6% (100/350) of the eye symptom reports after the baseline visit. For Discontinued Test eyes no symptoms were reported at 13.2% (10/76) of the eye symptom reports while the Discontinued Control eyes reported no symptoms at 15% (3/20) of the eye symptom reports.
slit lamp observations greater than grade 3

Full Information

First Posted
October 1, 2008
Last Updated
June 12, 2012
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00766168
Brief Title
High Refractive Index Material 510(k)
Acronym
PVS-07-07
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Seventy six (76) subjects (152 eyes) were enrolled and dispensed in the multisite, randomized, double masked clinical study to provide data that support the presumption of equivalence of the HDS HI 1.54™ investigational lenses to a historical control contact lens. Sixty four (64) subjects (84.2%) completed the study and 12 subjects (15.8%) were discontinued. The population demographics were similar to previous contact lens studies. Of the ten Test subjects who discontinued, Difficulty Cleaning Lenses (3 subjects) and Poor Comfort (2 subjects), Poor Vision (1 subject) and Poor Vision and Poor Comfort (2 subjects) accounted for 80% of the discontinuations. Two Control subjects discontinued, one for Loss of Interest and one for Poor Comfort There were no adverse events reported during the study. The only study related complications were slit lamp findings of grade 3 for injection. Each of these resolved without complication. Slit lamp findings were reported at frequencies within expected values and the positive slit lamp observations were primarily grade 1 (trace). Staining and injection were reported most frequently. Subject reports of no symptoms were lowest at the 1 week visit for both the Completed Test and Control eyes and then increased over the remainder of the study. Discomfort was reported most frequently (13.7% of Completed Test eye visits and 12.3% of Completed Control Eye visits). . Lens comfort was rated as an average of 4.04 (very good) for the Completed Test eyes and 4.07 (very good) for the Completed Control eyes. This compared to a baseline value of 3.96 for the Test eyes and 4.23 for the Control eyes with the pre-study habitual correction. Keratometry changes were within 1.00 diopter for 93.1% of the Completed Test eyes and 96.4% of the Completed Control eyes. Manifest refraction changes were within 1.00 diopter for 97.9% of the Completed Test eyes and 98.2% of the Completed Control eyes. One eye of the 63 Completed Test eyes targeted for full distance vision was reported to show a decrease in contact lens visual acuity from the baseline best corrected visual acuity of greater than 0.20 logMAR. The reason for the loss was a reported baseline measurement error. One eye of the 48 Completed Control eyes targeted for full distance vision was reported to show a decrease in contact lens visual acuity from the baseline best corrected visual acuity of greater than 0.20 logMAR. The reason cited for the decrease was lenses being switched eye for eye. Average lens wearing time was stable at over 13 hours per day for the Completed Test and Control subjects and showed a decrease over time for the discontinued eyes. Forty nine (49) lens replacements were made for 40 of the 152 eyes dispensed in the study. The replacements were predominantly for deposits (8) or parameter and power change (21) which together account for 59% of the lens replacements. Discomfort was cited for 18.4% (5 test and 4 control lenses) of the lens replacements. Five lenses (10%) were replaced due to loss. The results of the clinical evaluation of the Paragon HDS HI 1.54™ contact lenses provide evidence of substantial equivalence to the historical control, Paragon Fluroperm® 30 contact lenses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Hyperopia
Keywords
contact lens, rigid gas permeable, refractive index

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
FluoroPerm 30 RGP lens daily wear
Arm Title
HDS HI 1.54
Arm Type
Experimental
Arm Description
New rigid gas permeable contact lens material material
Intervention Type
Other
Intervention Name(s)
HDS HI 1.54; pahrifocon A
Other Intervention Name(s)
pahrifocon A
Intervention Description
Contact Lens
Intervention Type
Device
Intervention Name(s)
FluoroPerm 30 RGP; paflufocon C
Other Intervention Name(s)
paflufocon C
Intervention Description
Contact lens daily wear
Primary Outcome Measure Information:
Title
Best Corrected Visual Acuity vs Control
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Incidence of problems , symptoms and complaints vs control
Description
For the Completed Test eyes, no symptoms were reported for 23.0% (107/466) of the eye symptom reports after the baseline visit. For the Completed Control eyes, no symptoms were reported for 28.6% (100/350) of the eye symptom reports after the baseline visit. For Discontinued Test eyes no symptoms were reported at 13.2% (10/76) of the eye symptom reports while the Discontinued Control eyes reported no symptoms at 15% (3/20) of the eye symptom reports.
Time Frame
3 months
Title
slit lamp observations greater than grade 3
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerome A. Legerton, OD, MS
Organizational Affiliation
Consultant to Paragon Vision Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Mission Optometry
City
Lake Elsinore
State/Province
California
ZIP/Postal Code
92530
Country
United States
Facility Name
Eyecare Consultants
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Vision Care Associates
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48823
Country
United States
Facility Name
Koetting Associates
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63144
Country
United States
Facility Name
Visionary Eye Associates
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Western Reserve Vision Care
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Choate Eye Associates
City
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072
Country
United States
Facility Name
Twin Lakes Vision Clinic
City
Federal Way
State/Province
Washington
ZIP/Postal Code
98023
Country
United States

12. IPD Sharing Statement

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High Refractive Index Material 510(k)

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