Visual AcuityPhase 1NCT06131476
Clinical Investigation of Visual Acuity in Contact Lens Wearers After Instillation of a Lipid- Based Lubricating Eye Drop
A Phase 1 study testing Blink® Tears eye drops and Investigational lipid eye drops in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 2 sites in United States.
Trial summary
This is a single visit, randomized, double masked, bilateral, non-dispensing, 2×2 crossover study to assess visual acuity. 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 and Investigational lipid eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Sep 2020to 10 Oct 2020
- Phase
- Phase 1
- 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.
- Between 18 and 69 (inclusive) years of age at the time of screening.
- Subjects must be habitual spherical soft contact lens wearers.
- 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:
- Currently pregnant or breast-feeding.
- Diabetes.
- Any ocular or systemic allergies or disease which may interfere with the clinical trial (at the discretion of the investigator).
- Any systemic disease, autoimmune disease, or use of medication which may interfere with the clinical trial (at the discretion of the investigator).
Show all 16Show fewer
- Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report.
- 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 rigid gas permeable lens within the past 3 months5. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g., SynergEyes, SoftPerm) within the past 6 months.
- Current habitual use of Prescription Medication 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 members of an employee of the clinical site by self-report.
- Any Grade 3 or greater biomicroscopy findings (this includes, corneal edema, corneal staining, cornea vascularization, conjunctival injection, tarsal abnormalities, bulbar injection) on the FDA classification 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.\ In addition to the above criteria, patients with any allergy or sensitivity to ingredients that this product may contain should not participate in the study (Castor Oil, Polyoxyl 40 Hydrogenated Castor Oil, Sodium Chlorite, Boric Acid, Sodium Borate Decahydrate, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Polyethylene Glycol 400, Sodium Hyaluronate, Purified Water).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Vue Optical Boutique
Jacksonville, Florida, 32205
St. Johns Eye Associates, P.A.
Saint Augustine, Florida, 32092
About this study
This is a single visit, randomized, double masked, bilateral, non-dispensing, 2×2 crossover study to assess visual acuity.
- Conditions
- Visual Acuity
- Being tested
- Blink® Tears eye drops, Investigational lipid eye drops
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blink® Tears eye dropsDrug
Control Drops
Investigational lipid eye dropsDrug
Test Drops
| 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 the TEST lubricating eye drops, with a washout period of 90 minutes between instillations. After the wash-out period, the CONTROL lubricating eye drops will be instilled. Receives: Drug: Blink® Tears eye drops; Drug: Investigational lipid eye drops |
| Control/Test | Experimental | Eligible subjects who are habitual soft contact lens wearers will be randomized into the Test/Control sequence, to receive the CONTROL lubricating eye drops, with a washout period of 90 minutes between instillations. After the wash-out period, the TEST lubricating eye drops will be instilled. Receives: Drug: Blink® Tears eye drops; Drug: Investigational lipid eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity (logMAR) at 3 Minutes Post Instillation
High contrast bright illumination monocular logMAR (Logarithm of the Minimum Angle of Resolution) visual acuity was assessed at distance (4 meters) using ETDRS Charts, near (40 cm) and intermediate (64 cm) using reduced Guillon-Poling charts. A value of 0.0 logMAR indicated a Snellen vision of 20/20. Lower logMAR visual acuity values indicate better vision. The average logMAR visual acuity for each treatment was reported.
Measured: 3 minutes post instillation
Visual Acuity (logMAR) at 10 Minutes Post Instillation
High contrast bright illumination monocular logMAR (Logarithm of the Minimum Angle of Resolution) visual acuity was assessed at distance (4 meters) using ETDRS Charts, near (40 cm) and intermediate (64 cm) using reduced Guillon-Poling charts. A value of 0.0 logMAR indicated a Snellen vision of 20/20. Lower logMAR visual acuity values indicate better vision. The average logMAR visual acuity for each treatment was reported.
Measured: 10 minutes post instillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start16 Sep 2020
- Primary completion10 Oct 2020
- Study completion10 Oct 2020
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 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
- NCT06131476
- Sponsor's protocol ID
- CR-6371
- Status last verified
- Jun 2024
- First submitted
- 9 Nov 2023
- Last updated
- 26 Jun 2024
- 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 26 Jun 2024. 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 a Lipid- Based Lubricating Eye Drop
- ClinicalTrials.gov ID
- NCT06131476
- Acronym / sponsor ID
- CR-6371
- Conditions
- Visual Acuity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 10 Oct 2020 (actual)
- Study completion
- 10 Oct 2020 (actual)
- First posted
- 14 Nov 2023 (actual)
- Results
- Posted 26 Jun 2024
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 single visit, randomized, double masked, bilateral, non-dispensing, 2×2 crossover study to assess visual acuity.
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 | Drug: Blink® Tears eye drops, Drug: Investigational lipid eye dropsEligible subjects who are habitual soft contact lens wearers will be randomized into the Test/Control sequence, to receive the TEST lubricating eye drops, with a washout period of 90 minutes between instillations. After the wash-out period, the CONTROL lubricating eye drops will be instilled. |
| Control/Test | Experimental | Drug: Blink® Tears eye drops, Drug: Investigational lipid eye dropsEligible subjects who are habitual soft contact lens wearers will be randomized into the Test/Control sequence, to receive the CONTROL lubricating eye drops, with a washout period of 90 minutes between instillations. After the wash-out period, the TEST lubricating eye drops will be instilled. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Between 18 and 69 (inclusive) years of age at the time of screening.
- Subjects must be habitual spherical soft contact lens wearers.
Key exclusion criteria (16 listed)
- 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 discretion of the investigator).
- Any systemic disease, autoimmune disease, or use of medication which may interfere with the clinical trial (at the discretion of the investigator).
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 dropsControl Drops | Drug | Control/Test, Test/Control |
| Investigational lipid eye dropsTest Drops | Drug | Control/Test, Test/Control |
Primary outcome
Visual Acuity (logMAR) at 3 Minutes Post Instillation
Time frame: 3 minutes post instillation
High contrast bright illumination monocular logMAR (Logarithm of the Minimum Angle of Resolution) visual acuity was assessed at distance (4 meters) using ETDRS Charts, near (40 cm) and intermediate (64 cm) using reduced Guillon-Poling charts. A value of 0.0 logMAR indicated a Snellen vision of 20/20. Lower logMAR visual acuity values indicate better vision. The average logMAR visual acuity for each treatment was reported.
Visual Acuity (logMAR) at 10 Minutes Post Instillation
Time frame: 10 minutes post instillation
High contrast bright illumination monocular logMAR (Logarithm of the Minimum Angle of Resolution) visual acuity was assessed at distance (4 meters) using ETDRS Charts, near (40 cm) and intermediate (64 cm) using reduced Guillon-Poling charts. A value of 0.0 logMAR indicated a Snellen vision of 20/20. Lower logMAR visual acuity values indicate better vision. The average logMAR visual acuity for each treatment was reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Blink® Tears eye drops and Investigational lipid eye drops in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 2 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 6 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 26 Jun 2024. 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 26 Jun 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?
Visual Acuity (logMAR) at 3 Minutes Post Instillation (time frame: 3 minutes post instillation). 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 26 Jun 2024.