Visual AcuityPhase 2NCT05814367
Clinical Investigation of Visual Acuity in Contact Lens Wearers After Instillation of Investigational Lubricating Eye Drops
A Phase 2 study testing Blink® Tears eye drops in a multidose bottle and Preservative-free investigational lubricating eye drops in a Novelia® eyedropper in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 3 sites in United States.
Trial summary
This will be a single-visit, multi-site, randomized, single-masked, bilateral, active-controlled, non-dispensing, 2X2 crossover study. 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?
- Blink® Tears eye drops in a multidose bottle and Preservative-free investigational lubricating eye drops in a Novelia® eyedropper
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 Apr 2023to 6 May 2023
- Phase
- Phase 2
- 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 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.
- Be between 18 and 69 (inclusive) years of age at the time of screening.
- By self-report, habitually wear soft spherical contact lenses in both eyes in a daily reusable or daily disposable wear modality (i.e., not extended wear modality). Habitual wear is defined as a minimum of 6 hours per day, for a minimum of 2 days per week during the last 30 days.
- Subjects must achieve visual acuity of 20/30 or better in each eye, with their habitual contact lenses.
Who cannot join
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- The subject must not:
- Be currently pregnant or lactating.
- Be diabetic.
- Be currently using any ocular medications or have any ocular infection of any type which may interfere with the clinical trial (at the investigator's discretion).
- By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that might contraindicate or interfere with the clinical trial, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), autoimmune disease (e.g., rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See section 9.1 for additional details regarding excluded systemic medications.
Show all 15Show fewer
- Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g., SynergEyes, SoftPerm) within the past 3 months.
- Have participated in any pharmaceutical or medical device related clinical trial within 14 days prior to study enrollment.
- Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.
- Be a current habitual user of prescription medication to treat dry eye and ocular discomfort, ocular steroids, or any medication (RX or OTC) except artificial tears, that would interfere with the clinical study (at the discretion of the investigator).
- Have any known allergy or sensitivity to ingredients that the investigational product may contain (e.g., Sodium Chlorite, Boric Acid, Sodium Borate Decahydrate, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Polyethylene Glycol 400, Sodium Hyaluronate and Purified Water).
- Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities, or bulbar injection) or other corneal or ocular disease or abnormalities that contraindicate participation or may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis).
- Have a history of strabismus or amblyopia.
- Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, cataract removal, retinal laser photocoagulation, etc.).
- Have any significant corneal distortion due to previous contact lens wear, surgery, or pathology (At the discretion of the investigator).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
VRC
Jacksonville, Florida, 32256
Maitland Vision Center - North Orlando Ave
Maitland, Florida, 32751
Tyler Eye Associates
Tyler, Texas, 75703
About this study
This will be a single-visit, multi-site, randomized, single-masked, bilateral, active-controlled, non-dispensing, 2X2 crossover study.
- Conditions
- Visual Acuity
- Being tested
- Blink® Tears eye drops in a multidose bottle, Preservative-free investigational lubricating eye drops in a Novelia® eyedropper
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blink® Tears eye drops in a multidose bottleDrug
Control
Preservative-free investigational lubricating eye drops in a Novelia® eyedropperDrug
Test
| Study group | Role | What they receive |
|---|---|---|
| Test/Control | Experimental | Eligible subjects who are habitual soft contact lens wearers will be randomized into the Test/Control sequence, to receive 1-2 drops on each eye (right eye followed by left eye) over soft spherical contact lenses, over two wear periods (test then control). A washout period of 90 minutes between eyedrop instillations will occur. The second eyedrop as per the randomization schedule will follow the same procedure as previously stated. Receives: Drug: Blink® Tears eye drops in a multidose bottle; Drug: Preservative-free investigational lubricating eye drops in a Novelia® eyedropper |
| Control/Test | Experimental | Eligible subjects who are habitual soft contact lens wearers will be randomized into the Control/Test sequence, to receive 1-2 drops on each eye (right eye followed by left eye) over soft spherical contact lenses, over two wear periods (control then test). A washout period of 90 minutes between eyedrop instillations will occur. The second eyedrop as per the randomization schedule will follow the same procedure as previously stated. Receives: Drug: Blink® Tears eye drops in a multidose bottle; Drug: Preservative-free investigational lubricating eye drops in a Novelia® eyedropper |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocular logMAR Visual Acuity
Monocular visual acuity was measured at distance (4meter) using a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast lighting conditions. VA was assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual acuity score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
Measured: 10 Minutes Post Eye Drop Administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start6 Apr 2023
- Primary completion6 May 2023
- Study completion6 May 2023
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Vision Care, Inc. Clinical Trial, Study director, Johnson & Johnson Vision Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814367
- Sponsor's protocol ID
- CR-6503
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2023
- Last updated
- 27 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of Visual Acuity in Contact Lens Wearers After Instillation of Investigational Lubricating Eye Drops
- ClinicalTrials.gov ID
- NCT05814367
- Acronym / sponsor ID
- CR-6503
- Conditions
- Visual Acuity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Apr 2023 (actual)
- Primary completion
- 6 May 2023 (actual)
- Study completion
- 6 May 2023 (actual)
- First posted
- 14 Apr 2023 (actual)
- Results
- Posted 28 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a single-visit, multi-site, randomized, single-masked, bilateral, active-controlled, non-dispensing, 2X2 crossover study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test/Control | Experimental | Drug: Blink® Tears eye drops in a multidose bottle, Drug: Preservative-free investigational lubricating eye drops in a Novelia® eyedropperEligible subjects who are habitual soft contact lens wearers will be randomized into the Test/Control sequence, to receive 1-2 drops on each eye (right eye followed by left eye) over soft spherical contact lenses, over two wear periods (test then control). A washout period of 90 minutes between eyedrop instillations will occur. The second eyedrop as per the randomization schedule will follow the same procedure as previously stated. |
| Control/Test | Experimental | Drug: Blink® Tears eye drops in a multidose bottle, Drug: Preservative-free investigational lubricating eye drops in a Novelia® eyedropperEligible subjects who are habitual soft contact lens wearers will be randomized into the Control/Test sequence, to receive 1-2 drops on each eye (right eye followed by left eye) over soft spherical contact lenses, over two wear periods (control then test). A washout period of 90 minutes between eyedrop instillations will occur. The second eyedrop as per the randomization schedule will follow the same procedure as previously stated. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- 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.
- Be between 18 and 69 (inclusive) years of age at the time of screening.
- By self-report, habitually wear soft spherical contact lenses in both eyes in a daily reusable or daily disposable wear modality (i.e., not extended wear modality). Habitual wear is defined as a minimum of 6 hours per day, for a minimum of 2 days per week during the last 30 days.
Key exclusion criteria (15 listed)
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Be currently pregnant or lactating.
- Be diabetic.
- Be currently using any ocular medications or have any ocular infection of any type which may interfere with the clinical trial (at the investigator's discretion).
- By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that might contraindicate or interfere with the clinical trial, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), autoimmune disease (e.g., rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See section 9.1 for additional details regarding excluded systemic medications.
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 |
|---|---|---|
| Blink® Tears eye drops in a multidose bottleControl | Drug | Control/Test, Test/Control |
| Preservative-free investigational lubricating eye drops in a Novelia® eyedropperTest | Drug | Control/Test, Test/Control |
Primary outcome
Monocular logMAR Visual Acuity
Time frame: 10 Minutes Post Eye Drop Administration
Monocular visual acuity was measured at distance (4meter) using a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast lighting conditions. VA was assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual acuity score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
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.
Johnson & Johnson Vision Care, Inc. Clinical Trial study director
Johnson & Johnson Vision Care, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Blink® Tears eye drops in a multidose bottle and Preservative-free investigational lubricating eye drops in a Novelia® eyedropper in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 3 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 7 inclusion and 15 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 27 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 3 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 28 May 2024). 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?
Monocular logMAR Visual Acuity (time frame: 10 Minutes Post Eye Drop Administration). 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 27 Apr 2025.