Myopia; AstigmatismNCT02625220
Dispensing Evaluation of Investigational Contact Lenses
A study testing Prototype toric lens senofilcon A in people with Myopia; Astigmatism, run by Johnson & Johnson Vision Care, Inc. at 12 sites in United States.
Trial summary
Non-randomized, single-masked, 2-visit, bilateral wear, single-arm dispensing study to evaluate the visual acuity, rotational performance, lens fit, stability and subjective characteristics of a senofilcon-based JJVCI investigational toric contact lens design. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia; Astigmatism
- What is being tested?
- Prototype toric lens senofilcon A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 12 sitesUnited States
- Study dates
- Oct 2015to Nov 2015
- 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 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult males or females that are ≥18 years of age and ≤39 years of age.
- 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 a habitual toric contact lens wearer. Habitual wearer is defined as someone who wears toric lenses for at least 6 hours a day, 5 days a week for the past 30 days.
- Subject's vertex corrected spherical component of their distance refraction must be between -1.50 Diopters Sphere (DS) to -4.00 DS (inclusive) in each eye.
- Subject's vertex corrected refractive cylinder must be between -0.75 and -1.50 Diopters Cylinder (DC) (inclusive) in each eye.
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- Subject's refractive cylinder axis must be within 180±15° and 90±15° in each eye.
- If needed, the subject must have a wearable pair of spectacles with 20/30 or better vision Ocular Uterque (OU). If spectacles are not needed, the subject must have 20/40 or better vision OU without correction.
- Subject's best corrected distance acuity must be 20/25-2 or better in each eye.
Who cannot join
- Females who are currently pregnant or lactating.
- Any ocular or systemic allergies or diseases that may contraindicate contact lens wear.
- Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndromes, xerophthalmia, acne rosacea, and/or Stevens-Johnson syndromes, by self-report.
- Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV), by self-report.
- Habitual wearer of extended wear contact lenses.
- Any previous history of ocular and/or refractive surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
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- History of seizures.
- Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by report.
- History of binocular vision abnormality or strabismus, by self-report.
- Habitual wearer of rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
- Employee and family members of employee of investigational clinic (e.g., Investigator, Coordinator, Technician).
- Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
- Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, and conjunctival injection) on the FDA classification scale.
- Any history of a contact lens-related corneal inflammatory event within the past year that may contraindicate contact lens wear.
- Any active ocular infection.
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- Any fluctuations in vision due to clinically significant dry eye or other ocular conditions.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
ABQ Eyecare
Albuquerque, New Mexico, 87109
Eyecare Associates
Bloomington, Illinois, 61701
Indiana University College of Optometry
Bloomington, Indiana, 47405
Edward S. Wygonik, OD
Jacksonville, Florida, 32250
Total Eye Care PA
Memphis, Tennessee, 38119
The Eye Center
Pembroke Pines, Florida, 33024
Kannarr Eye Care
Pittsburg, Kansas, 66762
New Image Eye Center
Springfield, Ohio, 45503
Sacco Eye Group
Vestal, New York, 13850
West Bay Eye Associates
Warwick, Rhode Island, 02888
Professional Vision Care
Westerville, Ohio, 43081
Eye Associates of Winter Park
Winter Park, Florida, 32792
About this study
Non-randomized, single-masked, 2-visit, bilateral wear, single-arm dispensing study to evaluate the visual acuity, rotational performance, lens fit, stability and subjective characteristics of a senofilcon-based JJVCI investigational toric contact lens design.
- Conditions
- Myopia; Astigmatism
- Being tested
- Prototype toric lens senofilcon A
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prototype toric lens senofilcon ADevice
Investigational prototype
| Study group | Role | What they receive |
|---|---|---|
| Prototype toric lens senofilcon A | Experimental | Subjects will wear the senofilcon A prototype toric contact lens bilaterally for 6-8 days as a daily disposable modality. Receives: Device: Prototype toric lens senofilcon A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Eyes With Monocular Visual Acuity Better Than 20/40
Monocular visual acuity was assessed using distance Snellen visual acuity. Visual Acuity data was dichotomized such that 'response=1' if a subjects has 20/40 or better and 'response=0' if subject has worse than 20/40. The proportion of eyes with 20/40 or better was reported.
Measured: 7 day follow-up
The Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees
Absolute rotation was measured using a slit lamp. Absolute rotation measured at 15-minute post insertion was categorized into a binary outcome as 'response=1' if the absolute rotation is less than or equal to 10 degrees or 'response=0' otherwise. The proportion of eyes with absolute rotation less than or equal to 10 degrees was reported.
Measured: 15 Minutes Post Insertion
Proportion of Subjects Eyes With Lens Stability With Blink Within 5 Degrees
Lens stability with blink was measured using a slit lamp. The rotational stability of the lens during a series of normal (unforced) blinks was measured for both eyes. The data was dichotomized as 'response=1' if the lens stability was less than or equal to 5 degrees or 'response=0' otherwise. The proportion of eyes with rotational stability of 5 degrees or lower was reported.
Measured: 15 Minutes Post Insertion
Proportion of Subject Eyes With Acceptable Lens Fit
Acceptability of contact lens fit was assessed via slit lamp and was reported as a binary response as Acceptable or Unacceptable. The proportion of eyes with acceptable fit was reported.
Measured: 15 Minute Post Insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study startOct 2015
- Primary completionNov 2015
- Study completionNov 2015
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 Myopia; 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625220
- Sponsor's protocol ID
- CR-5769
- Status last verified
- May 2017
- First submitted
- 3 Nov 2015
- Last updated
- 7 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dispensing Evaluation of Investigational Contact Lenses
- ClinicalTrials.gov ID
- NCT02625220
- Acronym / sponsor ID
- CR-5769
- Conditions
- Myopia; Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 9 Dec 2015 (estimated)
- Results
- Posted 7 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-randomized, single-masked, 2-visit, bilateral wear, single-arm dispensing study to evaluate the visual acuity, rotational performance, lens fit, stability and subjective characteristics of a senofilcon-based JJVCI investigational toric contact lens design.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prototype toric lens senofilcon A | Experimental | Device: Prototype toric lens senofilcon ASubjects will wear the senofilcon A prototype toric contact lens bilaterally for 6-8 days as a daily disposable modality. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy adult males or females that are ≥18 years of age and ≤39 years of age.
- 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 a habitual toric contact lens wearer. Habitual wearer is defined as someone who wears toric lenses for at least 6 hours a day, 5 days a week for the past 30 days.
- Subject's vertex corrected spherical component of their distance refraction must be between -1.50 Diopters Sphere (DS) to -4.00 DS (inclusive) in each eye.
Key exclusion criteria (17 listed)
- Females who are currently pregnant or lactating.
- Any ocular or systemic allergies or diseases that may contraindicate contact lens wear.
- Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndromes, xerophthalmia, acne rosacea, and/or Stevens-Johnson syndromes, by self-report.
- Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV), by self-report.
- Habitual wearer of extended wear contact lenses.
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 |
|---|---|---|
| Prototype toric lens senofilcon AInvestigational prototype | Device | Prototype toric lens senofilcon A |
Primary outcome
Proportion of Eyes With Monocular Visual Acuity Better Than 20/40
Time frame: 7 day follow-up
Monocular visual acuity was assessed using distance Snellen visual acuity. Visual Acuity data was dichotomized such that 'response=1' if a subjects has 20/40 or better and 'response=0' if subject has worse than 20/40. The proportion of eyes with 20/40 or better was reported.
The Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees
Time frame: 15 Minutes Post Insertion
Absolute rotation was measured using a slit lamp. Absolute rotation measured at 15-minute post insertion was categorized into a binary outcome as 'response=1' if the absolute rotation is less than or equal to 10 degrees or 'response=0' otherwise. The proportion of eyes with absolute rotation less than or equal to 10 degrees was reported.
Proportion of Subjects Eyes With Lens Stability With Blink Within 5 Degrees
Time frame: 15 Minutes Post Insertion
Lens stability with blink was measured using a slit lamp. The rotational stability of the lens during a series of normal (unforced) blinks was measured for both eyes. The data was dichotomized as 'response=1' if the lens stability was less than or equal to 5 degrees or 'response=0' otherwise. The proportion of eyes with rotational stability of 5 degrees or lower was reported.
Proportion of Subject Eyes With Acceptable Lens Fit
Time frame: 15 Minute Post Insertion
Acceptability of contact lens fit was assessed via slit lamp and was reported as a binary response as Acceptable or Unacceptable. The proportion of eyes with acceptable fit was reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prototype toric lens senofilcon A in people with Myopia; Astigmatism, run by Johnson & Johnson Vision Care, Inc. at 12 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 9 inclusion and 17 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 7 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 12 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?
Yes. Results are posted in the registry (first posted 7 Jun 2017). 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?
Proportion of Eyes With Monocular Visual Acuity Better Than 20/40 (time frame: 7 day follow-up). The study lists 4 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 7 Jun 2017.