MyopiaPhase 3NCT01735045
LSH Silicone Hydrogel Soft Hydrophilic Contact Lens for Daily Wear
A Phase 3 study testing Lagado LSH (mangofilcon A) Soft (hydrophilic) Contact Lens and Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens in people with Myopia, run by Szabocsik and Associates, Inc. at 5 sites in United States.
Trial summary
This study is to evaluate the performance of the LSH (mangofilcon A) silicone hydrogel soft contact lenses when used as a daily wear contact lens for the correction of myopia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Lagado LSH (mangofilcon A) Soft (hydrophilic) Contact Lens and Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2010to Jan 2012
- Phase
- Phase 3
- 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
- Have been advised that the contact lenses they will be wearing for the next 3 months are being used for investigational purposes and that their informed consent will be needed and documented prior to the start of the study.
- Visual acuity must be correctable to 20/30, with spherical lenses ranging in power from -1.00 to -5.00D, astigmatism≤1.50D.
- Have been successfully wearing soft (hydrophilic) contact lenses for at least one month prior to entering the study. (Success means both subject and practitioner are satisfied with visual acuity, comfort, and ocular physiology).
- Have non-diseased eyes which are normal or which have no preexisting ocular condition which would interfere with the patient's ability to adapt to the new pair of LSH Silicone Hydrogel Soft (hydrophilic) Contact Lenses. A normal eye is defined as one having all the following characteristics:
- No evidence of lid infection.
- No structural lid abnormality.
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- No conjunctival abnormality or infection.
- A cornea which is clear with no edema, staining, vascularization or abnormal opacities, all as observed by slit lamp examination.
- No iritis.
- No other active ocular disease that would contraindicate use of the investigational lens.
- No GPC (giant papillary conjunctivitis, tarsal abnormality) Grade 2 or greater
- Use no ocular medication.
- Have no known sensitivity to solutions currently used for contact lens care.
- Have binocular correction with contact lenses.
Who cannot join
- Astigmatism >1.50D
- No monocular or monovision fits may be included.
- Pregnant and lactating women are excluded from the study
- Minors (under age 18) are excluded from the study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Douglas P. Benoit, OD, FAAO
Concord, New Hampshire, 03301
Randall Sakamoto
Honolulu, Hawaii, 96814
Glenda Secor, OD
Huntington Beach, California, 92647
Stephen P. Byrnes, OD, FAAO
Londonderry, New Hampshire, 03053
Robert Davis, OD
Oak Lawn, Illinois, 60453
About this study
This study is to evaluate the performance of the LSH (mangofilcon A) silicone hydrogel soft contact lenses when used as a daily wear contact lens for the correction of myopia.
- Conditions
- Myopia
- Being tested
- Lagado LSH (mangofilcon A) Soft (hydrophilic) Contact Lens, Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lagado LSH (mangofilcon A) Soft (hydrophilic) Contact LensDevice
Daily Wear
Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact LensDevice
| Study group | Role | What they receive |
|---|---|---|
| Test Group myopia control | Experimental | Subjects wearing contact lenses made of LSH (mangofilcon A) Soft (hydrophilic) Contact Lens for myopia control Receives: Device: Lagado LSH (mangofilcon A) Soft (hydrophilic) Contact Lens |
| Myopia Control | Active comparator | Subjects wearing Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens for myopia control Receives: Device: Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Snelling Scale
Measured: 3 months
Secondary outcomes (1)
Slit Lamp Findings
Grading by the Slit Lamp Classification Scale
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 posted28 Nov 2012 (estimated)
- Study startMay 2010
- Primary completionDec 2011
- Study completionJan 2012
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Szabocsik and Associates, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John M Szabocsik, PhD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01735045
- Sponsor's protocol ID
- HF-2010-01
- Status last verified
- Nov 2012
- First submitted
- 11 Jun 2012
- Last updated
- 28 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LSH Silicone Hydrogel Soft Hydrophilic Contact Lens for Daily Wear
- ClinicalTrials.gov ID
- NCT01735045
- Acronym / sponsor ID
- HF-2010-01
- Conditions
- Myopia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Szabocsik and Associates, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 28 Nov 2012 (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.
This study is to evaluate the performance of the LSH (mangofilcon A) silicone hydrogel soft contact lenses when used as a daily wear contact lens for the correction of myopia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group myopia control | Experimental | Device: Lagado LSH (mangofilcon A) Soft (hydrophilic) Contact LensSubjects wearing contact lenses made of LSH (mangofilcon A) Soft (hydrophilic) Contact Lens for myopia control |
| Myopia Control | Active comparator | Device: Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact LensSubjects wearing Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens for myopia control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Have been advised that the contact lenses they will be wearing for the next 3 months are being used for investigational purposes and that their informed consent will be needed and documented prior to the start of the study.
- Visual acuity must be correctable to 20/30, with spherical lenses ranging in power from -1.00 to -5.00D, astigmatism≤1.50D.
- Have been successfully wearing soft (hydrophilic) contact lenses for at least one month prior to entering the study. (Success means both subject and practitioner are satisfied with visual acuity, comfort, and ocular physiology).
- Have non-diseased eyes which are normal or which have no preexisting ocular condition which would interfere with the patient's ability to adapt to the new pair of LSH Silicone Hydrogel Soft (hydrophilic) Contact Lenses. A normal eye is defined as one having all the following characteristics:
- Use no ocular medication.
Key exclusion criteria (4 listed)
- Astigmatism >1.50D
- No monocular or monovision fits may be included.
- Pregnant and lactating women are excluded from the study
- Minors (under age 18) are excluded from the study
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 |
|---|---|---|
| Lagado LSH (mangofilcon A) Soft (hydrophilic) Contact LensDaily Wear | Device | Test Group myopia control |
| Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens | Device | Myopia Control |
Primary outcome
Visual Acuity
Time frame: 3 months
Snelling Scale
1 secondary outcome
Slit Lamp Findings
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 28 Nov 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.
John M Szabocsik, PhD study director
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lagado LSH (mangofilcon A) Soft (hydrophilic) Contact Lens and Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens in people with Myopia, run by Szabocsik and Associates, Inc. at 5 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 14 inclusion and 4 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 28 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Visual Acuity (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 28 Nov 2012.