MyopiaPVS-07-07NCT00766168
High Refractive Index Material 510(k)
A study testing HDS HI 1.54; pahrifocon A and FluoroPerm 30 RGP; paflufocon C in people with Myopia and Hyperopia, run by CooperVision International Limited (CVIL) at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- What is being tested?
- HDS HI 1.54; pahrifocon A and FluoroPerm 30 RGP; paflufocon C
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 8 sitesUnited States
- Study dates
- Jan 2008to Aug 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Western Reserve Vision Care
Beachwood, Ohio, 44122
Vision Care Associates
East Lansing, Michigan, 48823
Eyecare Consultants
Englewood, Colorado, 80112
Twin Lakes Vision Clinic
Federal Way, Washington, 98023
Choate Eye Associates
Goodlettsville, Tennessee, 37072
Mission Optometry
Lake Elsinore, California, 92530
Visionary Eye Associates
Rochester, New York, 14618
Koetting Associates
St Louis, Missouri, 63144
About this study
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.
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.
Read the 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.
- Being tested
- HDS HI 1.54; pahrifocon A, FluoroPerm 30 RGP; paflufocon C
- Keywords
- contact lens, rigid gas permeable, refractive index
- Medical subject headings
- Myopia, Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDS HI 1.54; pahrifocon AOther
Also called pahrifocon A
Contact Lens
FluoroPerm 30 RGP; paflufocon CDevice
Also called paflufocon C
Contact lens daily wear
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | FluoroPerm 30 RGP lens daily wear Receives: Device: FluoroPerm 30 RGP; paflufocon C |
| HDS HI 1.54 | Experimental | New rigid gas permeable contact lens material material Receives: Other: HDS HI 1.54; pahrifocon A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
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.
Measured: 3 months
slit lamp observations greater than grade 3
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2008 (estimated)
- Study startJan 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision International Limited (CVIL)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jerome A. Legerton, OD, MS, Study director, Consultant to Paragon Vision Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766168
- Sponsor's protocol ID
- HDSHI154
- Other IDs
- PVS-07-07
- Acronym
- PVS-07-07
- Status last verified
- Jun 2012
- First submitted
- 1 Oct 2008
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00766168
- Acronym / sponsor ID
- PVS-07-07 / HDSHI154
- Keywords
- contact lens, rigid gas permeable, refractive index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- CooperVision International Limited (CVIL)Industry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 3 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: FluoroPerm 30 RGP; paflufocon CFluoroPerm 30 RGP lens daily wear |
| HDS HI 1.54 | Experimental | Other: HDS HI 1.54; pahrifocon ANew rigid gas permeable contact lens material material |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HDS HI 1.54; pahrifocon AAlso: pahrifocon AContact Lens | Other | HDS HI 1.54 |
| FluoroPerm 30 RGP; paflufocon CAlso: paflufocon CContact lens daily wear | Device | Control |
Primary outcome
Best Corrected Visual Acuity vs Control
Time frame: 3 months
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.
2 secondary outcomes
Incidence of problems , symptoms and complaints vs control
Time frame: 3 months
slit lamp observations greater than grade 3
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerome A. Legerton, OD, MS study director
Consultant to Paragon Vision Sciences
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HDS HI 1.54; pahrifocon A and FluoroPerm 30 RGP; paflufocon C in people with Myopia and Hyperopia, run by CooperVision International Limited (CVIL) at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Corrected Visual Acuity vs Control (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2012; AzTrials last refreshed its copy on 27 Oct 2026.