Visual AcuityNCT03670277
Evaluation of On-eye Optical Performances of the RMY-100 Lens
A study testing etafilcon A and Habitual Orthokeratology Lenses in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in Canada.
Trial summary
This is a two-arm parallel, non-masked, bilateral, non-dispensing study with one Test arm and one concurrent, non-randomized Control arm to evaluate the one-eye optical performances of the test soft contact lens and compare with eyes treated with orthokeratology. Read more about this study
- Who is it for?
- Ages 7 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity
- What is being tested?
- etafilcon A and Habitual Orthokeratology Lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- 22 Aug 2018to 19 Feb 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- Pediatric subjects (<18 years old) must read (or be read to), understand, and sign the Statement of Information and Assent and receive a fully executed copy of the form.
- Adult subjects (≥18 years old) and parent(s) or legal guardian(s) of pediatric subjects must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form.
- Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Between 7 and 25 years of age (inclusive).
- Have normal eyes (i.e., no ocular medications or infections of any type).
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- Vertex-corrected distance subjective best-sphere refraction must be between -1.00D and -5.00D (inclusive) in each eye.
- Cylindrical refraction must be 1.00D or less in each eye, by subjective sphero-cylindrical refraction.
- Have sphero-cylindrical best-corrected visual acuity of 20/25 or better in each eye.
- Below inclusion criterion is for subjects to be enrolled to the Control group only:
- Are existing orthokeratology patients whose current treatment has been stabilized for at least 1 months and with complete pre-treatment record, e.g., spherocylindrical refraction and corneal topography. Pre-treatment wavefront aberration measures are preferred by not required.
Who cannot join
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Currently pregnant or lactating.
- Any systemic allergies, infectious disease (e.g., hepatitis, tuberculosis), autoimmune disease (e.g., rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study.
- Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear and/or participation in the study.
- Any current use of ocular topical medication (occasional use of re-wetting drops is allowed).
- Any previous or planned ocular or intraocular surgery, including refractive surgery.
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- Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
- Employee or their children/relatives of investigational clinic (e.g., Investigator, Coordinator, Technician). 8 . Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to, aphakia, uveitis, ocular hypertension, glaucoma, severe keratoconjunctivitis sicca, history of recurrent corneal erosions, keratoconus, keratoconus suspect, pellucid marginal degeneration, entropion, ectropion, extrusions, chalazia, and recurrent styes.
- 9 . Any Grade 3 or greater slit lamp findings (eg, edema, corneal neovascularization, corneal staining, tarsal abnormalities, and conjunctival injection) on the FDA scale.
- 10 . Any ocular abnormality that is contraindicated contact lens wear. 11 . Any corneal scar within central 5mm 12 . Binocular vision abnormality, intermittent strabismus or strabismus. Below exclusion criteria are for subjects to be enrolled to the Test group only 13 . Current or recent (within 30 days from enrollment) rigid lens wearers. 14 . History of orthokeratology treatment. 15. Any corneal distortion resulting from ocular diseases or previous hard or rigid gas permeable contact lens wear.
Trial locations and contacts
1 site in 1 country.
About this study
This is a two-arm parallel, non-masked, bilateral, non-dispensing study with one Test arm and one concurrent, non-randomized Control arm to evaluate the one-eye optical performances of the test soft contact lens and compare with eyes treated with orthokeratology.
- Conditions
- Visual Acuity
- Being tested
- etafilcon A, Habitual Orthokeratology Lenses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etafilcon ADevice
Test Soft Contact Lens
Habitual Orthokeratology LensesDevice
CONTROL
| Study group | Role | What they receive |
|---|---|---|
| TEST arm | Experimental | For subjects enrolled in the Test arm, the Test Soft Contact Lens will be bilaterally fitted to the subject's eyes. Endpoint measures will be collected over one eye only - Test Arm: OD only. Receives: Device: etafilcon A |
| CONTROL arm | Experimental | Subjects enrolled in the Control Arm will be established orthokeratology lens wearers. Endpoint measures will be collected over one eye only - Control Arm: Better OK fitted eyes based on investigator's judgement. Receives: Device: Habitual Orthokeratology Lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance Spherical Aberration (Z4, 0)
Spherical aberration (Z4, 0) for a 5-mm pupil was measured by an aberrometer (COAS by AMO) with a distant viewing target at 4 m at the Baseline and post lens fitting. The Control Group only had 1 study Visit that record Baseline measurements, no intervention from the sponsor was implemented for this group, therefore data was collected on a bare eye. The Test group was fitted with the study lens at Visit 2 and data was collected with the Test lens on eye.
Measured: Up to Post Lens Fitting Evaluation
Near Spherical Aberration (Z4, 0)
Spherical aberration (Z4, 0) for a 5 mm pupil was measured by an aberrometer (COAS by AMO) with a near view target at 25 cm. at the Baseline and post lens fitting. The Control Group only had 1 study Visit that record Baseline measurements, no intervention from the sponsor was implemented for this group, therefore data was collected on a bare eye. The Test group was fitted with the study lens at Visit 2 and data was collected with the Test lens on eye.
Measured: Up to Post Lens Fitting Evaluation
Secondary outcomes (2)
Distance Off-axis Refraction at ±10°, ±20°, and ±30° Retinal Eccentricities.
Distance off-axis refractions were measured by an open-field autorefractor (WAM-5500 by Grand Seiko) with distant viewing targets at 4 m and ±10°, ±20°, and ±30° off axis. at the Baseline and post lens fitting. The Control Group only had 1 study Visit that record Baseline measurements, no intervention from the sponsor was implemented for this group, therefore data was collected on a bare eye. The Test group was fitted with the study lens at Visit 2 and data was collected with the Test lens on eye.
Measured: Up to Post Lens Fitting Evaluation
Near Off-axis Refraction at ±30° Retinal Eccentricities.
Near off-axis refractions were measured by an open-field autorefractor (WAM-5500 by Grand Seiko) with near viewing targets at 25 cm and ±30° off-axis. at the Baseline and post lens fitting. The Control Group only had 1 study Visit that record Baseline measurements, no intervention from the sponsor was implemented for this group, therefore data was collected on a bare eye. The Test group was fitted with the study lens at Visit 2 and data was collected with the Test lens on eye.
Measured: Up to Post Lens Fitting Evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start22 Aug 2018
- Primary completion19 Feb 2019
- Study completion19 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Visual AcuityStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xu Cheng, Study chair, Johnson & Johnson Vision Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670277
- Sponsor's protocol ID
- CR-6000
- Status last verified
- Apr 2025
- First submitted
- 12 Sep 2018
- Last updated
- 25 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of On-eye Optical Performances of the RMY-100 Lens
- ClinicalTrials.gov ID
- NCT03670277
- Acronym / sponsor ID
- CR-6000
- Conditions
- Visual Acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Aug 2018 (actual)
- Primary completion
- 19 Feb 2019 (actual)
- Study completion
- 19 Feb 2019 (actual)
- First posted
- 13 Sep 2018 (actual)
- Results
- Posted 14 Jan 2022
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 two-arm parallel, non-masked, bilateral, non-dispensing study with one Test arm and one concurrent, non-randomized Control arm to evaluate the one-eye optical performances of the test soft contact lens and compare with eyes treated with orthokeratology.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEST arm | Experimental | Device: etafilcon AFor subjects enrolled in the Test arm, the Test Soft Contact Lens will be bilaterally fitted to the subject's eyes. Endpoint measures will be collected over one eye only - Test Arm: OD only. |
| CONTROL arm | Experimental | Device: Habitual Orthokeratology LensesSubjects enrolled in the Control Arm will be established orthokeratology lens wearers. Endpoint measures will be collected over one eye only - Control Arm: Better OK fitted eyes based on investigator's judgement. |
Who may qualify
- Ages
- 7 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Key exclusion criteria (10 listed)
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- 9 . Any Grade 3 or greater slit lamp findings (eg, edema, corneal neovascularization, corneal staining, tarsal abnormalities, and conjunctival injection) on the FDA scale.
- 10 . Any ocular abnormality that is contraindicated contact lens wear. 11 . Any corneal scar within central 5mm 12 . Binocular vision abnormality, intermittent strabismus or strabismus. Below exclusion criteria are for subjects to be enrolled to the Test group only 13 . Current or recent (within 30 days from enrollment) rigid lens wearers. 14 . History of orthokeratology treatment. 15. Any corneal distortion resulting from ocular diseases or previous hard or rigid gas permeable contact lens wear.
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 |
|---|---|---|
| etafilcon ATest Soft Contact Lens | Device | TEST arm |
| Habitual Orthokeratology LensesCONTROL | Device | CONTROL arm |
Primary outcome
Distance Spherical Aberration (Z4, 0)
Time frame: Up to Post Lens Fitting Evaluation
Spherical aberration (Z4, 0) for a 5-mm pupil was measured by an aberrometer (COAS by AMO) with a distant viewing target at 4 m at the Baseline and post lens fitting. The Control Group only had 1 study Visit that record Baseline measurements, no intervention from the sponsor was implemented for this group, therefore data was collected on a bare eye. The Test group was fitted with the study lens at Visit 2 and data was collected with the Test lens on eye.
Near Spherical Aberration (Z4, 0)
Time frame: Up to Post Lens Fitting Evaluation
Spherical aberration (Z4, 0) for a 5 mm pupil was measured by an aberrometer (COAS by AMO) with a near view target at 25 cm. at the Baseline and post lens fitting. The Control Group only had 1 study Visit that record Baseline measurements, no intervention from the sponsor was implemented for this group, therefore data was collected on a bare eye. The Test group was fitted with the study lens at Visit 2 and data was collected with the Test lens on eye.
2 secondary outcomes
Distance Off-axis Refraction at ±10°, ±20°, and ±30° Retinal Eccentricities.
Time frame: Up to Post Lens Fitting Evaluation
Near Off-axis Refraction at ±30° Retinal Eccentricities.
Time frame: Up to Post Lens Fitting Evaluation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Xu Cheng study chair
Johnson & Johnson Vision Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing etafilcon A and Habitual Orthokeratology Lenses in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in Canada.
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 11 inclusion and 10 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 25 Apr 2025. 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 Canada. 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?
Yes. Results are posted in the registry (first posted 14 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Distance Spherical Aberration (Z4, 0) (time frame: Up to Post Lens Fitting Evaluation). 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 25 Apr 2025.