Corneal DiseaseNCT00804505
Hybrid SA RGP Center/S-H Skirt Daily Wear 90 Day Multicenter Study
A study testing SynergEyes Hybrid (petrafocon A hem-larafilcon A) Hybrid Contact Lens and SynergEyes Hybrid (paflufocon D hem-iberfilcon A) Contact Lens in people with Corneal Disease and Hypersensitivity, run by SynergEyes, Inc. at 8 sites in United States.
Trial summary
The purpose of the study is to demonstrate that the SynergEyes SA Hybrid Contact Lens clinical performance is substantially equivalent to that of the SynergEyes A Hybrid Lens when studied: within the corresponding range of lens powers in a population randomized within multiple investigational sites with a study ration… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Corneal Disease, Hypersensitivity
- What is being tested?
- SynergEyes Hybrid (petrafocon A hem-larafilcon A) Hybrid Contact Lens and SynergEyes Hybrid (paflufocon D hem-iberfilcon A) Contact Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 8 sitesUnited States
- Study dates
- Jun 2008to Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Prior to being considered eligible to participate in this study, each subject MUST:
- Be at least 18 years of age as of the date of evaluation.
- Have
- read the Informed Consent,
- been given an explanation of the Informed Consent,
- indicated an understanding of the Informed Consent and
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- signed the Informed Consent Form.
- Be willing and able to adhere to the instructions set forth in this protocol and able to keep all specified appointments.
- Be a current contact lens wearer.
- Possess wearable and visually functional eyeglasses.
- Be in good general health, based on his/her knowledge.
- Require spectacle lens powers between plano and -6.00 diopters sphere with no more than -2.50 diopters of spectacle refractive astigmatism and be willing to wear lenses in both eyes.
- Have manifest refraction visual acuity equal to or better than 20/25 in each eye.
Who cannot join
- Subjects may not be enrolled into the study if ANY of the following apply:
- Subject is wearing lenses in a monovision modality and is unwilling to be fit with distance lenses in both eyes. NOTE: Subjects may NOT wear monovision lenses at any time during the study as it will interfere with the distance visual acuity measurement.
- Subject exhibits poor personal hygiene.
- Subject is currently or within 30 days prior to this study has been an active participant in another clinical study.
- Subject is currently pregnant (to the best of the subject's knowledge), is planning a pregnancy within the next 3 months or is lactating.
- Subject is a member, relative or household member of the office staff, including the investigator(s).
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- Subject has a known sensitivity to ingredients used in contact lens care products or over-the-counter lubricants and artificial tears.
- Subject has undergone refractive surgery or is currently receiving or has previously received orthokeratology treatment.
- Subject is aphakic or pseudophakic.
- Subject has ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, Sjögren's syndrome lupus erythematosus, scleroderma, keratoconus or type II diabetes.
- Use of ocular medications for any reason or systemic medications which might interfere with contact lens wear.
- A known history of corneal hypoesthesia (reduced corneal sensitivity).
- Slit lamp findings that would contraindicate contact lens wear, including but not limited to:
- History of corneal ulcer, corneal infiltrates or fungal infections
- Corneal scars within the visual axis
- Pterygium
- Dry eye symptoms with decrease tear levels and punctate staining ≥ Grade 2
- Neovascularization or ghost vessels > 1.5 mm in from the limbus
- Seborrhoeic eczema, seborrhoeic conjunctivitis
- History of papillary conjunctivitis that has interfered with lens wear or a current condition of Grade 2 (Mild) or greater
- Clinically significant (Grade 3 or 4) anterior segment abnormalities or any infection of the eye, lids, or associated structures.
- TO BE ELIGIBLE TO BE RANDOMIZED FOR STUDY PRODUCT TRIAL A SUBJECT MUST HAVE ALL OF THE INCLUSION CRITERIA AND NONE OF THE EXCLUSION CRITERIA PRESENT.
- TO BE ELIGIBLE FOR LENS DISPENSING, THE SUBJECT'S STUDY DEVICE CONTACT LENS VISUAL ACUITY MUST BE EQUAL TO OR BETTER THAN 20/30 IN EACH EYE
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Casazza Optometric Group
Andover, Massachusetts, 01810
Western Reserve Vision Care, Inc.
Beachwood, Ohio, 44122
Primary Eyecare Group P.C.
Brentwood, Tennessee, 37027
Vision Care Associates
East Lansing, Michigan, 48823
Snowy Range Vision Center
Laramie, Wyoming, 82070
Dr. Karambelas & Associates
Providence, Rhode Island, 02906
Carmel Mountain Vision Care
San Diego, California, 92129
Silicon Valley Eye Physicians
Sunnyvale, California, 94087
About this study
Official title: A 90 Day Multi-Center, Randomized, Parallel Group Daily Wear Investigation of a New Hybrid Lens SynergEyes SA Manufactured With a Rigid Gas Permeable Center (Petrafocon A) and a Silicone Hydrogel Skirt (Larafilcon A) Compared to SynergEyes A (Paflufocon D Hem-iberfilcon A)
The purpose of the study is to demonstrate that the SynergEyes SA Hybrid Contact Lens clinical performance is substantially equivalent to that of the SynergEyes A Hybrid Lens when studied:
- within the corresponding range of lens powers
- in a population randomized within multiple investigational sites
- with a study ration of 2/1 test vs control lenses
- for a duration of 90 days.
Read the detailed description
The objective of the study is to compare the SynergEyes SA Hybrid Contact Lens (Test) to the SynergEyes A Hybrid Contact lens (Control) when used in a daily wear regimen on non-diseased eyes for the correction of myopia (-0.25 to -6.00Diopters) with up to -2.50 Diopters of astigmatism. The population will be randomized into a 2/1 ratio of the Test/Control for 90 days. The study objective is to complete at least 40 subjects in the Test material and 20 subjects in the Control material.
The purpose of the study is to demonstrate that the SynergEyes SA Hybrid Contact Lens clinical performance is substantially equivalent to that of the SynergEyes A Hybrid Lens when studied within the corresponding range of powers in a population randomized within investigational sites to produce a 2/1 ratio of Test vs. Control lenses.
- Conditions
- Corneal Disease, Hypersensitivity
- Being tested
- SynergEyes Hybrid (petrafocon A hem-larafilcon A) Hybrid Contact Lens, SynergEyes Hybrid (paflufocon D hem-iberfilcon A) Contact Lens
- Keywords
- Substantial equivalence to control device
- Medical subject headings
- Corneal Diseases, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynergEyes Hybrid (petrafocon A hem-larafilcon A) Hybrid Contact LensDevice
Comparison to control hybrid lens with similar 'dose'minimum 8 hours daily use for up to 90 days.
SynergEyes Hybrid (paflufocon D hem-iberfilcon A) Contact LensDevice
Comparison to test lens: Daily use for minimum 8 hours up to 90 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Test arm daily wear hybrid contact lens. Receives: Device: SynergEyes Hybrid (petrafocon A hem-larafilcon A) Hybrid Contact Lens |
| 2 | Other | Control: SynergEyes Hybrid (paflufocon D hem-iberfilcon A) Hybrid Contact Lens Receives: Device: SynergEyes Hybrid (paflufocon D hem-iberfilcon A) Contact Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of objective findings (slit lamp, lens fitting, deposits, subjective symptoms, adverse events test vs control
Measured: 3 months
Visual acuity comparison test/control.
Measured: 3 mo.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startJun 2008
- Primary completionNov 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal DiseaseStudies 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
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- SynergEyes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- William Gleason, OD, Study director, Foresight Regulatory Strategies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804505
- Sponsor's protocol ID
- SI-0804 V1.0
- Status last verified
- Dec 2009
- First submitted
- 8 Dec 2008
- Last updated
- 23 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 90 Day Multi-Center, Randomized, Parallel Group Daily Wear Investigation of a New Hybrid Lens SynergEyes SA Manufactured With a Rigid Gas Permeable Center (Petrafocon A) and a Silicone Hydrogel Skirt (Larafilcon A) Compared to SynergEyes A (Paflufocon D Hem-iberfilcon A)
- ClinicalTrials.gov ID
- NCT00804505
- Acronym / sponsor ID
- SI-0804 V1.0
- Conditions
- Corneal Disease, Hypersensitivity
- Keywords
- Substantial equivalence to control device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- SynergEyes, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 9 Dec 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 the study is to demonstrate that the SynergEyes SA Hybrid Contact Lens clinical performance is substantially equivalent to that of the SynergEyes A Hybrid Lens when studied:
- within the corresponding range of lens powers
- in a population randomized within multiple investigational sites
- with a study ration of 2/1 test vs control lenses
- for a duration of 90 days.
Detailed description
The objective of the study is to compare the SynergEyes SA Hybrid Contact Lens (Test) to the SynergEyes A Hybrid Contact lens (Control) when used in a daily wear regimen on non-diseased eyes for the correction of myopia (-0.25 to -6.00Diopters) with up to -2.50 Diopters of astigmatism. The population will be randomized into a 2/1 ratio of the Test/Control for 90 days. The study objective is to complete at least 40 subjects in the Test material and 20 subjects in the Control material.
The purpose of the study is to demonstrate that the SynergEyes SA Hybrid Contact Lens clinical performance is substantially equivalent to that of the SynergEyes A Hybrid Lens when studied within the corresponding range of powers in a population randomized within investigational sites to produce a 2/1 ratio of Test vs. Control lenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: SynergEyes Hybrid (petrafocon A hem-larafilcon A) Hybrid Contact LensTest arm daily wear hybrid contact lens. |
| 2 | Other | Device: SynergEyes Hybrid (paflufocon D hem-iberfilcon A) Contact LensControl: SynergEyes Hybrid (paflufocon D hem-iberfilcon A) Hybrid Contact Lens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Be at least 18 years of age as of the date of evaluation.
- Have
- Be willing and able to adhere to the instructions set forth in this protocol and able to keep all specified appointments.
- Be a current contact lens wearer.
- Possess wearable and visually functional eyeglasses.
Key exclusion criteria (23 listed)
- Subjects may not be enrolled into the study if ANY of the following apply:
- TO BE ELIGIBLE TO BE RANDOMIZED FOR STUDY PRODUCT TRIAL A SUBJECT MUST HAVE ALL OF THE INCLUSION CRITERIA AND NONE OF THE EXCLUSION CRITERIA PRESENT.
- TO BE ELIGIBLE FOR LENS DISPENSING, THE SUBJECT'S STUDY DEVICE CONTACT LENS VISUAL ACUITY MUST BE EQUAL TO OR BETTER THAN 20/30 IN EACH EYE
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 |
|---|---|---|
| SynergEyes Hybrid (petrafocon A hem-larafilcon A) Hybrid Contact LensComparison to control hybrid lens with similar 'dose'minimum 8 hours daily use for up to 90 days. | Device | 1 |
| SynergEyes Hybrid (paflufocon D hem-iberfilcon A) Contact LensComparison to test lens: Daily use for minimum 8 hours up to 90 days. | Device | 2 |
Primary outcome
Comparison of objective findings (slit lamp, lens fitting, deposits, subjective symptoms, adverse events test vs control
Time frame: 3 months
Visual acuity comparison test/control.
Time frame: 3 mo.
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 23 Dec 2009.
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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.
William Gleason, OD study director
Foresight Regulatory Strategies, Inc.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SynergEyes Hybrid (petrafocon A hem-larafilcon A) Hybrid Contact Lens and SynergEyes Hybrid (paflufocon D hem-iberfilcon A) Contact Lens in people with Corneal Disease and Hypersensitivity, run by SynergEyes, Inc. 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 13 inclusion and 23 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 23 Dec 2009. 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?
Comparison of objective findings (slit lamp, lens fitting, deposits, subjective symptoms, adverse events test vs control (time frame: 3 months). The study lists 2 primary outcomes in all. 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 23 Dec 2009.