Visual AcuityPhase 4NCT03466086
Clinical Evaluation of Two Marketed Artificial Tears in Non-contact Lens Wearing Patients
A Phase 4 study testing Test Eye Drops in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in United Kingdom.
Trial summary
This clinical study is a randomized, double-masked, cross-over, bilateral, 2 treatment x 2 period, dispensing 4-visit study with a 7-9 day washout period in between visits 2 and 3. The study will last approximately 3 months. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity
- What is being tested?
- Test Eye Drops
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Feb 2018to 16 May 2018
- Phase
- Phase 4
- 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 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Potential subjects must satisfy all the following criteria to be enrolled in the study:
- Subjects must be at least 18 years of age and no more than 69 years of age (inclusive)
- Subjects must be non-contact lens wearers
- Subjects must have a DEQ-5 score of >6 at either Visit 0 (pre-screen) and/or Visit 1 (screening).
- Subjects must achieve visual acuity of 20/30 (equivalent to 0.18 logMAR) or better in each eye, either unaided or best corrected.
- Subjects must possess a functional/usable pair of spectacles and bring them to every visit (only if applicable - to the investigators discretion).
- Subjects must read, understand, and sign the Statement of Informed Consent.
- Subjects must appear able and willing to adhere to the instructions set forth in this clinical protocol
Who cannot join
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Currently pregnant or breast-feeding.
- Diabetes.
- Any ocular or systemic allergies or disease which may interfere with the clinical trial (at the investigator's discretion).
- Any systemic disease, autoimmune disease, or use of medication which may interfere with the clinical trial (at the investigator's discretion).
- Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report
Show all 16Show fewer
- Any Grade 3 or greater biomicroscopy findings (this includes, corneal edema, corneal staining, corneal vascularization, conjunctival injection, tarsal abnormalities, bulbar injection) on the FDA scale
- Any active ocular abnormalities/conditions that may interfere with the clinical trial (this includes, but not limited to, chalazia, recurrent styles, pterygium, infection, etc)
- Any corneal distortion due to previous rigid gas permeable lens wear, surgery or pathology
- History of any ocular or corneal surgery (e.g. RK, PRK, LASIK)
- Participation in any pharmaceutical or medical device related clinical trial within 14 days prior to study enrollment.
- History of binocular vision abnormality or strabismus.
- Habitual wearers of soft contact lenses in the past 1 month or rigid gas permeable lens within the past 3 months
- Current habitual use of Prescription Only Medicines (POM) to treat dry eye or ocular discomfort, ocular steroids, or any medication (RX or OTC) that would interfere with the clinical study (at the discretion of the investigator).)
- Employees of investigational clinic (investigator, coordinator, and technician etc) or family member of an employee of the clinical site by self-report.
- In addition to the above criteria, patients with any allergy or sensitivity to ingredients that this product may contain (liposomes, sodium hyaluronate, vitamin E polyethylene glycol succinate (TPGS), polyethylene glycol 400 (PEG 400), disodium edetate, polyhexanide methylbiguanide, propylene glycol, boric acid, dimyristoyl phosphatidylglycerol, edetate disodium, hydroxypropyl guar, mineral oil, polyoxyl 40 sterate, polyquaternium-1, sorbitan tristearate, sorbitol, hydrochloric acid and/or sodium hydroxide) should not participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
This clinical study is a randomized, double-masked, cross-over, bilateral, 2 treatment x 2 period, dispensing 4-visit study with a 7-9 day washout period in between visits 2 and 3. The study will last approximately 3 months.
- Conditions
- Visual Acuity
- Being tested
- Test Eye Drops, Control Eye Drops
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test Eye DropsDevice
blink® intensive TRIPLE ACTION 3 in 1 eye drops
Control Eye DropsDevice
Systane® BALANCE eye drops
| Study group | Role | What they receive |
|---|---|---|
| Test/Control | Experimental | Subjects between the ages of 18-69 years of age will sequentially try the Test and Control eye drops in a random order Receives: Device: Test Eye Drops; Device: Control Eye Drops |
| Control/Test | Experimental | Subjects between the ages of 18-69 years of age will sequentially try the Control and Test eye drops in a random order. Receives: Device: Test Eye Drops; Device: Control Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Comfort
Ocular comfort was measured using the visual analogue scale of 0 to 100. Where 0 is extremely uncomfortable and 100 is extremely comfortable.
Measured: 1-Week Follow-up
Secondary outcomes (1)
Subjective Dryness Rating
Subjective dryness was assessed using Ocular Surface Disease Index (OSDI©) instrument. Dryness is evaluated on a scale of 0 to 100, where higher scores indicate more symptoms of dryness
Measured: 1-Week Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start9 Feb 2018
- Primary completion16 May 2018
- Study completion16 May 2018
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 57 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
- NCT03466086
- Sponsor's protocol ID
- CR-6013
- Status last verified
- Jun 2019
- First submitted
- 26 Feb 2018
- Last updated
- 28 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- 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 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Two Marketed Artificial Tears in Non-contact Lens Wearing Patients
- ClinicalTrials.gov ID
- NCT03466086
- Acronym / sponsor ID
- CR-6013
- Conditions
- Visual Acuity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Feb 2018 (actual)
- Primary completion
- 16 May 2018 (actual)
- Study completion
- 16 May 2018 (actual)
- First posted
- 15 Mar 2018 (actual)
- Results
- Posted 29 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study is a randomized, double-masked, cross-over, bilateral, 2 treatment x 2 period, dispensing 4-visit study with a 7-9 day washout period in between visits 2 and 3. The study will last approximately 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test/Control | Experimental | Device: Test Eye Drops, Device: Control Eye DropsSubjects between the ages of 18-69 years of age will sequentially try the Test and Control eye drops in a random order |
| Control/Test | Experimental | Device: Test Eye Drops, Device: Control Eye DropsSubjects between the ages of 18-69 years of age will sequentially try the Control and Test eye drops in a random order. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Potential subjects must satisfy all the following criteria to be enrolled in the study:
Key exclusion criteria (16 listed)
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- In addition to the above criteria, patients with any allergy or sensitivity to ingredients that this product may contain (liposomes, sodium hyaluronate, vitamin E polyethylene glycol succinate (TPGS), polyethylene glycol 400 (PEG 400), disodium edetate, polyhexanide methylbiguanide, propylene glycol, boric acid, dimyristoyl phosphatidylglycerol, edetate disodium, hydroxypropyl guar, mineral oil, polyoxyl 40 sterate, polyquaternium-1, sorbitan tristearate, sorbitol, hydrochloric acid and/or sodium hydroxide) should not participate 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 |
|---|---|---|
| Test Eye Dropsblink® intensive TRIPLE ACTION 3 in 1 eye drops | Device | Control/Test, Test/Control |
| Control Eye DropsSystane® BALANCE eye drops | Device | Control/Test, Test/Control |
Primary outcome
Ocular Comfort
Time frame: 1-Week Follow-up
Ocular comfort was measured using the visual analogue scale of 0 to 100. Where 0 is extremely uncomfortable and 100 is extremely comfortable.
1 secondary outcome
Subjective Dryness Rating
Time frame: 1-Week Follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Visual Acuity
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Recruiting
Comparison of ACUVUE® OASYS MAX 1-Day Multifocal and DAILIES® AquaComfort Plus® Multifocal
Visual Acuity
Active, not recruiting
Evaluation of Approved Contact Lenses (CR-6657)
Visual Acuity
RecruitingPhase 3
Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)
Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
Neovascular Age-related Macular Degeneration
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Test Eye Drops in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in United Kingdom.
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 28 Jun 2019. 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 Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 May 2019). 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?
Ocular Comfort (time frame: 1-Week Follow-up). 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 28 Jun 2019.