Visual AcuityNCT03440242
Biomarker Discovery in Two Daily Disposable Contact Lenses
An observational study of Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 2 sites in India.
Trial summary
This is a non-masked, non-randomized, stratified, 4-arm parallel group, non-interventional study where subjects will be enrolled into one of four arms based on their habitual contact lenses. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity
- What is being tested?
- JJVC Contact Lens and Marketed Contact Lens
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- 2 sitesIndia
- Study dates
- 9 Jan 2018to 12 Oct 2018
- Phase
- Observational
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Study subjects will be recruited from the Institution/clinical site's subject database and/or utilizing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved materials.
Who may be able to join
- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- The subject 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.
- Appear able and willing to adhere to a no lens wear period of at least one month.
- Between 18 and 45 (inclusive) years of age at the time of screening.
- Subject must be currently wearing one of the two habitual contact lenses in both eyes (1DAM or DACP) for at least three months. Habitual CL wear is defined as having a minimum wearing time of 3 hours per day, minimum of 3 days per week for at least 3 months.
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- Subject must have visual acuity of at least 20/40 or better in each eye with their habitual lenses
- Subjects must meet one of the following criteria in order to be classified as either asymptomatic or symptomatic group:
- Asymptomatic group: CLDEQ-8 score of ≤7, difference between CWT and AWT <1 hours/day
- Symptomatic group: CLDEQ-8 score of ≥15, difference between CWT and AWT >3 hours/day
- Have healthy eyes with no evidence of abnormality or disease (i.e., no active ocular pathological conditions/ infections of any type).
- Have a pair of spectacles that provide corrected binocular visual acuity of 20/40 or better. If no spectacles, subjects must have un-aided binocular visual acuity of 20/40 or better.
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 disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), 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.
- Unacceptable lens fit with their habitual lenses in either eye based on study investigators judgment.
- Any extended wear modality.
- Use of systemic medications (e.g., chronic steroid use, immuno-suppressants or anti-infective medications) that are known to interfere with contact lens wear.
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- 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 entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion.
- Any previous, or planned (during the course of the study) intraocular/refractive surgery.
- Any Grade 3 or 4 slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, and conjunctival injection) on the FDA 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 would contraindicate contact lens wear.
- Participation in any interventional contact lens, eye drop or lens care product clinical trial within 30 days prior to study enrollment.
- Suspicion of or recent history of alcohol or substance abuse, serious mental illness, or seizures.
- Employee of clinical site (e.g., Investigator, Coordinator, Technician).
Trial locations and contacts
2 sites in 1 country.
India2 sites
Narayana Nethralaya Foundation
Bangalore
Medical Research Foundation
Chennai
About this study
This is a non-masked, non-randomized, stratified, 4-arm parallel group, non-interventional study where subjects will be enrolled into one of four arms based on their habitual contact lenses. Subjects will be wearing their habitual contact lenses throughout the study and will be scheduled for morning and afternoon visits totaling 10 visits with a ~4-week washout period between visits 6 and 7.
- Conditions
- Visual Acuity
- Being tested
- JJVC Contact Lens, Marketed Contact Lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JJVC Contact LensDevice
etafilcon A with PVP DD
Marketed Contact LensDevice
nelfilcon A DD
| Study group | Role | What they receive |
|---|---|---|
| JJVC Contact Lens (Asymptomatic) | Subjects between the ages of 18 and 45 years of age will be enrolled to the JJVC Contact Lens arm based on their habitual lenses and then stratified to an Asymptomatic group based on wear time responses during the baseline assessment. Receives: Device: JJVC Contact Lens | |
| JJVC Contact Lens (Symptomatic) | Subjects between the ages of 18 and 45 years of age will be enrolled to the JJVC Contact Lens arm based on their habitual lenses and then stratified to a Symptomatic group based on wear time responses during the baseline assessment. Receives: Device: JJVC Contact Lens | |
| Marketed Contact Lens (Asymptomatic) | Subjects between the ages of 18 and 45 years of age will be enrolled to the Marketed Contact Lens arm based on their habitual lenses and then stratified to an Asymptomatic group based on wear time responses during the baseline assessment. Receives: Device: Marketed Contact Lens | |
| Marketed Contact Lens (Symptomatic) | Subjects between the ages of 18 and 45 years of age will be enrolled to the Marketed Contact Lens arm based on their habitual lenses and then stratified to a Symptomatic group based on wear time responses during the baseline assessment. Receives: Device: Marketed Contact Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summary of Protein (Lysozyme) in Tears
Summarizing potential differences in biomarker responses in tears of subjects wearing two different materials of daily disposable contact lenses. Lysozyme as biomarker in tears will be collected via Schirmer's strips and Capillary tubes at all scheduled visits and will be analyzed using Chromatography.
Measured: Approximately 2 hours duration of assessment time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start9 Jan 2018
- Primary completion12 Oct 2018
- Study completion12 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 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
- NCT03440242
- Sponsor's protocol ID
- CR-5982
- Status last verified
- Nov 2018
- First submitted
- 25 Jan 2018
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Discovery in Two Daily Disposable Contact Lenses
- ClinicalTrials.gov ID
- NCT03440242
- Acronym / sponsor ID
- CR-5982
- Conditions
- Visual Acuity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jan 2018 (actual)
- Primary completion
- 12 Oct 2018 (actual)
- Study completion
- 12 Oct 2018 (actual)
- First posted
- 22 Feb 2018 (actual)
- 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 non-masked, non-randomized, stratified, 4-arm parallel group, non-interventional study where subjects will be enrolled into one of four arms based on their habitual contact lenses. Subjects will be wearing their habitual contact lenses throughout the study and will be scheduled for morning and afternoon visits totaling 10 visits with a ~4-week washout period between visits 6 and 7.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| JJVC Contact Lens (Asymptomatic) | – | Device: JJVC Contact LensSubjects between the ages of 18 and 45 years of age will be enrolled to the JJVC Contact Lens arm based on their habitual lenses and then stratified to an Asymptomatic group based on wear time responses during the baseline assessment. |
| JJVC Contact Lens (Symptomatic) | – | Device: JJVC Contact LensSubjects between the ages of 18 and 45 years of age will be enrolled to the JJVC Contact Lens arm based on their habitual lenses and then stratified to a Symptomatic group based on wear time responses during the baseline assessment. |
| Marketed Contact Lens (Asymptomatic) | – | Device: Marketed Contact LensSubjects between the ages of 18 and 45 years of age will be enrolled to the Marketed Contact Lens arm based on their habitual lenses and then stratified to an Asymptomatic group based on wear time responses during the baseline assessment. |
| Marketed Contact Lens (Symptomatic) | – | Device: Marketed Contact LensSubjects between the ages of 18 and 45 years of age will be enrolled to the Marketed Contact Lens arm based on their habitual lenses and then stratified to a Symptomatic group based on wear time responses during the baseline assessment. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Study subjects will be recruited from the Institution/clinical site's subject database and/or utilizing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved materials.
Key inclusion criteria (12 listed)
- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Key exclusion criteria (13 listed)
- Potential subjects who meet any of the following criteria will be excluded from participating in 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 |
|---|---|---|
| JJVC Contact Lensetafilcon A with PVP DD | Device | JJVC Contact Lens (Asymptomatic), JJVC Contact Lens (Symptomatic) |
| Marketed Contact Lensnelfilcon A DD | Device | Marketed Contact Lens (Asymptomatic), Marketed Contact Lens (Symptomatic) |
Primary outcome
Summary of Protein (Lysozyme) in Tears
Time frame: Approximately 2 hours duration of assessment time
Summarizing potential differences in biomarker responses in tears of subjects wearing two different materials of daily disposable contact lenses. Lysozyme as biomarker in tears will be collected via Schirmer's strips and Capillary tubes at all scheduled visits and will be analyzed using Chromatography.
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 14 Nov 2018.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 2 sites in India.
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 12 inclusion and 13 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 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. 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?
Summary of Protein (Lysozyme) in Tears (time frame: Approximately 2 hours duration of assessment time). 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 14 Nov 2018.