AstigmatismNCT02053688
Evaluation Study on Corneal Lens for Vision Correction
A study testing Astigmatic Correction Lens (Nexis ACCL lenses) and Toric Soft Contact Lenses in people with Astigmatism, run by FORSIGHT Vision3 at 6 sites in United States.
Trial summary
The objective of this study is to evaluate the fitting and visual outcomes of Nexis Lens, made of silicone commonly used in the contact lens industry, on healthy eye with or without astigmatism. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Astigmatism
- What is being tested?
- Astigmatic Correction Lens (Nexis ACCL lenses) and Toric Soft Contact Lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 6 sitesUnited States
- Study dates
- Feb 2013to Dec 2013
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient with good corneal health
- Age 18-65.
- Patients able to understand the requirements of the study and willing to follow study instructions, to provide written informed consent to participate, and who agree to comply with all study requirements.
- Best corrected visual acuity of 20/20 or better in the study eye/s
Who cannot join
- Any other anterior segment abnormality.
- No previous corneal procedures, including Laser Vision Correction.
- Any abnormalities associated with the eye lids.
- Clinically significant inflammation or infection within six (6) months prior to study.
- Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the Investigator.
- Participation in any study involving an investigational drug or device within the past 30 calendar days, or ongoing participation in a study with an investigational material except studies using corneal lenses.
Show all 9Show fewer
- Intolerance or hypersensitivity to topical anesthetics, fluorescein, or components of the material.
- Specifically known intolerance or hypersensitivity to contact lenses.
- Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Cliff Leong
Fremont, California, 94538
Sara Chiu
Fremont, California, 94538
John Michelsen
Livermore, California, 94550
Nexis Vision
Menlo Park, California, 94025
Nick Chan
San Mateo, California, 94401
Josephine Vo-Laurel
Stockton, California, 95219
About this study
The objective of this study is to evaluate the fitting and visual outcomes of Nexis Lens, made of silicone commonly used in the contact lens industry, on healthy eye with or without astigmatism.
- Conditions
- Astigmatism
- Being tested
- Astigmatic Correction Lens (Nexis ACCL lenses), Toric Soft Contact Lenses
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Astigmatic Correction Lens (Nexis ACCL lenses)Device
Astigmatic refractive error correction
Toric Soft Contact LensesDevice
astigmatism correction using toric optics
| Study group | Role | What they receive |
|---|---|---|
| Astigmatic Correction Lens | Active comparator | Nexis ACCL lenses vs commercial Toric Lenses Receives: Device: Astigmatic Correction Lens (Nexis ACCL lenses) |
| Toric Soft Contact Lenses | Active comparator | commercial toric soft contact lenses Receives: Device: Toric Soft Contact Lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Measured: 30 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startFeb 2013
- Primary completionNov 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AstigmatismStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- FORSIGHT Vision3
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ashley Tuan, OD, PhD, Principal investigator, Nexisvision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02053688
- Sponsor's protocol ID
- CL001
- Status last verified
- Jan 2014
- First submitted
- 30 Jan 2014
- Last updated
- 4 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Study on Corneal Lens for Vision Correction
- ClinicalTrials.gov ID
- NCT02053688
- Acronym / sponsor ID
- CL001
- Conditions
- Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- FORSIGHT Vision3Industry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 4 Feb 2014 (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 objective of this study is to evaluate the fitting and visual outcomes of Nexis Lens, made of silicone commonly used in the contact lens industry, on healthy eye with or without astigmatism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Astigmatic Correction Lens | Active comparator | Device: Astigmatic Correction Lens (Nexis ACCL lenses)Nexis ACCL lenses vs commercial Toric Lenses |
| Toric Soft Contact Lenses | Active comparator | Device: Toric Soft Contact Lensescommercial toric soft contact lenses |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with good corneal health
- Age 18-65.
- Patients able to understand the requirements of the study and willing to follow study instructions, to provide written informed consent to participate, and who agree to comply with all study requirements.
- Best corrected visual acuity of 20/20 or better in the study eye/s
Key exclusion criteria (9 listed)
- Any other anterior segment abnormality.
- No previous corneal procedures, including Laser Vision Correction.
- Any abnormalities associated with the eye lids.
- Clinically significant inflammation or infection within six (6) months prior to study.
- Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the Investigator.
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 |
|---|---|---|
| Astigmatic Correction Lens (Nexis ACCL lenses)Astigmatic refractive error correction | Device | Astigmatic Correction Lens |
| Toric Soft Contact Lensesastigmatism correction using toric optics | Device | Toric Soft Contact Lenses |
Primary outcome
Visual Acuity
Time frame: 30 mins
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 4 Feb 2014.
Related trials for Astigmatism
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
RecruitingPhase 4
Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
Astigmatism
Recruiting
Evaluation of Orthokeratology Lenses With a 5MM Optic Zone Diameter
Myopia, Astigmatism
Active, not recruiting
Wavelight Plus Sightmap-LASIK vs. Wavefront-Optimized-LASIK
Myopia, Astigmatism
Recruiting
Wear Experience With Daily Disposable Contact Lenses for Astigmatism Over a Long-Wear Day
Astigmatism
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.
Ashley Tuan, OD, PhD principal investigator
Nexisvision
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Astigmatic Correction Lens (Nexis ACCL lenses) and Toric Soft Contact Lenses in people with Astigmatism, run by FORSIGHT Vision3 at 6 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 9 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 4 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Visual Acuity (time frame: 30 mins). 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 4 Feb 2014.