Vision DisordersPhase 1NCT02540122
Pilot Clinical Evaluation of Approved Contact Lenses
A Phase 1 study testing Marketed Contact Lens 1, Marketed Contact Lens 2 and Marketed Contact Lens 3 in people with Vision Disorders, run by Johnson & Johnson Vision Care, Inc. at 1 site in United States.
Trial summary
This is a pilot evaluation to assess the feasibility of using novel imaging process to characterize lens edge and limbal epithelial thickness profile; lens movement with gaze and blink; and conjunctival microvasculature including fractal analysis of microvascular perfusion maps and blood flow velocity. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Vision Disorders
- What is being tested?
- Marketed Contact Lens 1, Marketed Contact Lens 2 and Marketed Contact Lens 3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Jun 2016
- Phase
- Phase 1
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- The subject must be at least 18 and not more than 70 years of age.
- The subject's refractive cylinder must be < 1.00 Diopters (D) in each eye.
- The subject must have best corrected visual acuity of 20/25 or better in each eye.
- The subject must be either a neophyte or a habitual and adapted wearer of soft contact lenses in both eyes.
- The subject must have normal eyes (i.e., no ocular medications or infections of any type).
- The subject must demonstrate adequate mobility and 20/30 vision oculus dexter (OD) and oculus sinister (OS) with the study contact lenses.
Who cannot join
- Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
- Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear.
- Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia.
- Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in-situ keratomileusis (LASIK), etc.).
- Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
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- Any ocular infection.
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- Monovision or multi-focal contact lens correction.
- Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
- History of binocular vision abnormality or strabismus.
- Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self report).
- Suspicion of or recent history of alcohol or substance abuse.
- History of serious mental illness.
- History of seizures.
- Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Imaging of Conjunctival Microvasculature During Contact Lens Wear
This is a pilot evaluation to assess the feasibility of using novel imaging process to characterize lens edge and limbal epithelial thickness profile; lens movement with gaze and blink; and conjunctival microvasculature including fractal analysis of microvascular perfusion maps and blood flow velocity.
Read the detailed description
This is a pilot evaluation to assess the feasibility of using ultra-high resolution optical coherence tomography (OCT) to image and characterize lens edge and limbal epithelial thickness profile; lens movement with gaze and blink; and conjunctival microvasculature including fractal analysis of microvascular perfusion maps and blood flow velocity.
- Conditions
- Vision Disorders
- Being tested
- Marketed Contact Lens 1, Marketed Contact Lens 2, Marketed Contact Lens 3, Marketed Contact Lens 4
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marketed Contact Lens 1Device
Also called etafilcon A
Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).
Marketed Contact Lens 2Device
Also called nelfilcon A
Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).
Marketed Contact Lens 3Device
Also called narafilcon A in 8.5 base curve
Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).
Marketed Contact Lens 4Device
Also called narafilcon A in 9.0 base curve
Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).
| Study group | Role | What they receive |
|---|---|---|
| Subject A (Neophytes) | Active comparator | Subjects will wear the Marketed Contact Lens 1, Marketed Contact Lens 2, Marketed Contact Lens 3, and Marketed Contact Lens 4 for a 6-hour period in a bilateral and random fashion, with a washout period of one week between lenses. Each subject will randomly be assigned to one of four unique sequences of a 4 x 4 crossover design. A block size of two sequences will be used. Receives: Device: Marketed Contact Lens 1; Device: Marketed Contact Lens 2; Device: Marketed Contact Lens 3; Device: Marketed Contact Lens 4 |
| Subject B (Habitual Lens Wearers) | Active comparator | Subjects will wear the Marketed Contact Lens 1, Marketed Contact Lens 2, Marketed Contact Lens 3, and Marketed Contact Lens 4 for a 6-hour period in a bilateral and random fashion, with a washout period of one week between lenses. Each subject will randomly be assigned to one of four unique sequences of a 4 x 4 crossover design. A block size of two sequences will be used. Receives: Device: Marketed Contact Lens 1; Device: Marketed Contact Lens 2; Device: Marketed Contact Lens 3; Device: Marketed Contact Lens 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Bulbar Conjunctival Blood Flow Velocity
Bulbar conjunctival microvascular responses among different types of contact lenses after a period of lens wear will be observed and evaluated for clinical relevance findings.
Measured: 4 contact lenses will be tested over a period of 21 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vision DisordersStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hong Jiang, MD, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540122
- Sponsor's protocol ID
- CR-5627
- Status last verified
- Jun 2017
- First submitted
- 31 Aug 2015
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging of Conjunctival Microvasculature During Contact Lens Wear
- ClinicalTrials.gov ID
- NCT02540122
- Acronym / sponsor ID
- CR-5627
- Conditions
- Vision Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 3 Sep 2015 (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 is a pilot evaluation to assess the feasibility of using novel imaging process to characterize lens edge and limbal epithelial thickness profile; lens movement with gaze and blink; and conjunctival microvasculature including fractal analysis of microvascular perfusion maps and blood flow velocity.
Detailed description
This is a pilot evaluation to assess the feasibility of using ultra-high resolution optical coherence tomography (OCT) to image and characterize lens edge and limbal epithelial thickness profile; lens movement with gaze and blink; and conjunctival microvasculature including fractal analysis of microvascular perfusion maps and blood flow velocity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subject A (Neophytes) | Active comparator | Device: Marketed Contact Lens 1, Device: Marketed Contact Lens 2, Device: Marketed Contact Lens 3, Device: Marketed Contact Lens 4Subjects will wear the Marketed Contact Lens 1, Marketed Contact Lens 2, Marketed Contact Lens 3, and Marketed Contact Lens 4 for a 6-hour period in a bilateral and random fashion, with a washout period of one week between lenses. Each subject will randomly be assigned to one of four unique sequences of a 4 x 4 crossover design. A block size of two sequences will be used. |
| Subject B (Habitual Lens Wearers) | Active comparator | Device: Marketed Contact Lens 1, Device: Marketed Contact Lens 2, Device: Marketed Contact Lens 3, Device: Marketed Contact Lens 4Subjects will wear the Marketed Contact Lens 1, Marketed Contact Lens 2, Marketed Contact Lens 3, and Marketed Contact Lens 4 for a 6-hour period in a bilateral and random fashion, with a washout period of one week between lenses. Each subject will randomly be assigned to one of four unique sequences of a 4 x 4 crossover design. A block size of two sequences will be used. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- The subject must be at least 18 and not more than 70 years of age.
- The subject's refractive cylinder must be < 1.00 Diopters (D) in each eye.
- The subject must have best corrected visual acuity of 20/25 or better in each eye.
Key exclusion criteria (16 listed)
- Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
- Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear.
- Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia.
- Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in-situ keratomileusis (LASIK), etc.).
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 |
|---|---|---|
| Marketed Contact Lens 1Also: etafilcon AMarketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes). | Device | Subject A (Neophytes), Subject B (Habitual Lens Wearers) |
| Marketed Contact Lens 2Also: nelfilcon AMarketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes). | Device | Subject A (Neophytes), Subject B (Habitual Lens Wearers) |
| Marketed Contact Lens 3Also: narafilcon A in 8.5 base curveMarketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes). | Device | Subject A (Neophytes), Subject B (Habitual Lens Wearers) |
| Marketed Contact Lens 4Also: narafilcon A in 9.0 base curveMarketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes). | Device | Subject A (Neophytes), Subject B (Habitual Lens Wearers) |
Primary outcome
Assessment of Bulbar Conjunctival Blood Flow Velocity
Time frame: 4 contact lenses will be tested over a period of 21 days.
Bulbar conjunctival microvascular responses among different types of contact lenses after a period of lens wear will be observed and evaluated for clinical relevance findings.
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 20 Jun 2017.
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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.
Hong Jiang, MD, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Marketed Contact Lens 1, Marketed Contact Lens 2 and Marketed Contact Lens 3 in people with Vision Disorders, run by Johnson & Johnson Vision Care, Inc. at 1 site 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 8 inclusion and 16 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 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Assessment of Bulbar Conjunctival Blood Flow Velocity (time frame: 4 contact lenses will be tested over a period of 21 days.). 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 20 Jun 2017.