Visual AcuityNCT03995355
Clinical Evaluation of an Investigational Lipid Drop in Non-contact Lens Wearing Patients
A study testing 9618X investigational lipid eye drops and Blink® Tears in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in United States.
Trial summary
This is a double-masked, randomized, bilateral, 2-Arm parallel group study. Subjects are scheduled for 3 study visits (screening/baseline, 7-Day and 30-Day follow-up visits) over a period of one month. 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?
- 9618X investigational lipid eye drops and Blink® Tears
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2019to 20 Sep 2019
- 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 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 achieve visual acuity of 20/30 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).
- Self-reported symptoms of ocular dryness or irritation and/or the use of artificial tears in the last 3 months.
- 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 30 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 Medicines 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 (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) should not participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
This is a double-masked, randomized, bilateral, 2-Arm parallel group study. Subjects are scheduled for 3 study visits (screening/baseline, 7-Day and 30-Day follow-up visits) over a period of one month.
- Conditions
- Visual Acuity
- Being tested
- 9618X investigational lipid eye drops, Blink® Tears
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9618X investigational lipid eye dropsDevice
Test Eye Drops
Blink® TearsDevice
Control Eye Drops
| Study group | Role | What they receive |
|---|---|---|
| Test Eye Drops | Experimental | Eligible subjects that are non-contact lens wearers will be randomized to the Test group throughout the duration of the study. Receives: Device: 9618X investigational lipid eye drops |
| Control Eye Drops | Active comparator | Eligible subjects that are non-contact lens wearers will be randomized to the Control group throughout the duration of the study. Receives: Device: Blink® Tears |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Ocular Comfort (30-Day)
Subjective overall ocular comfort was assessed at baseline, and at the 30-Day follow-up using a Visual Analogue Scale (VAS) ranging from 0 (extremely uncomfortable) to 100 (extremely comfortable). The change from baseline ocular comfort score was calculated as 30-Day follow-up score minus Baseline score. Change from Baseline VAS Scores range from -100 to 100, where higher change from baseline comfort scores indicates better performance. The average change from baseline comfort score for each Arm was report.
Measured: Baseline and 30-Day Follow-up
Secondary outcomes (5)
Change From Baseline Ocular Comfort (7-Day)
Subjective overall ocular comfort was assessed at baseline, and at the 7-Day follow-up using a Visual Analogue Scale (VAS) ranging from 0 (extremely uncomfortable) to 100 (extremely comfortable). The change from baseline ocular comfort score was calculated as 7-Day follow-up score minus Baseline score. Change from Baseline VAS Scores range from -100 to 100, where higher change from baseline comfort scores indicates better performance. The average change from baseline comfort score for each Arm was report.
Measured: Baseline and 7-Day Follow-up
Number of Subject Eyes That Reported Ocular Symptoms
Subjects were reported whether they experienced any ocular symptoms, problems or complaints (yes/no) by eye. Ocular symptoms were assessed for each subject eye at all study visits (scheduled and unscheduled). The number of eyes that experience ocular symptoms or complaints was reported for the 7- and 30-Day follow-up.
Measured: 7-Day Follow-up and 30-Day Follow-up
Number of Subject Eyes That Experience Grade 2 or Higher Corneal Staining
Corneal staining was analyzed using the FDA grading scale (ie, Grade 0 = None, Grade 1 = Trace, Grade 2 = Mild, Grade 3 = Moderate and Grade 4 = Severe). These responses were categorized into a binary outcome as 1 if any Grade 2 or higher corneal staining was observed or otherwise 0 is recorded. Subjects with multiple events were counted only once for the analysis purpose.
Measured: 7-Day Follow-up and 30-Day Follow-up
Change From Baseline Ocular Vision (7-Day)
Subjective overall ocular vision was assessed at baseline, dispensing and 7-Day follow-up using a Visual Analogue Scale (VAS) from 0 (extremely uncomfortable) to 100 (extremely comfortable). The change from baseline ocular vision score was calculated as 7-Day follow-up score minus Baseline score. Change from Baseline VAS Scores range from -100 to 100, where higher change from baseline vision scores indicates better performance. The average change from baseline vision score for each Arm was report.
Measured: Baseline and 7 Day-Day Follow-up
Change From Baseline Ocular Vision (30-Day)
Subjective overall ocular vision was assessed at baseline, dispensing and 30 Day follow-up using a Visual Analogue Scale (VAS) from 0 (extremely uncomfortable) to 100 (extremely comfortable). The change from baseline ocular vision score was calculated as 30-Day follow-up score minus Baseline score. Change from Baseline VAS Scores range from -100 to 100, where higher change from baseline vision scores indicates better performance. The average change from baseline vision score for each Arm was report.
Measured: Baseline and 30 Day Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start26 Jun 2019
- Primary completion20 Sep 2019
- Study completion20 Sep 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 161 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
- NCT03995355
- Sponsor's protocol ID
- CR-6328
- Status last verified
- Jun 2023
- First submitted
- 20 Jun 2019
- Last updated
- 3 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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
Publications
Donnenfeld E, Coats J, Barbour K, Ryan R, Joshi NR, Periman LM. Efficacy and safety of a lipid-containing artificial tear compared with a non-lipid containing tear: a randomized clinical trial. BMC Ophthalmol. 2024 Oct 8;24(1):442. doi: 10.1186/s12886-024-03688-z.
PubMed 39379885
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of an Investigational Lipid Drop in Non-contact Lens Wearing Patients
- ClinicalTrials.gov ID
- NCT03995355
- Acronym / sponsor ID
- CR-6328
- Conditions
- Visual Acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jun 2019 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 24 Jun 2019 (actual)
- Results
- Posted 14 Nov 2022
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 double-masked, randomized, bilateral, 2-Arm parallel group study. Subjects are scheduled for 3 study visits (screening/baseline, 7-Day and 30-Day follow-up visits) over a period of one month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Eye Drops | Experimental | Device: 9618X investigational lipid eye dropsEligible subjects that are non-contact lens wearers will be randomized to the Test group throughout the duration of the study. |
| Control Eye Drops | Active comparator | Device: Blink® TearsEligible subjects that are non-contact lens wearers will be randomized to the Control group throughout the duration of the study. |
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 (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) 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 |
|---|---|---|
| 9618X investigational lipid eye dropsTest Eye Drops | Device | Test Eye Drops |
| Blink® TearsControl Eye Drops | Device | Control Eye Drops |
Primary outcome
Change From Baseline Ocular Comfort (30-Day)
Time frame: Baseline and 30-Day Follow-up
Subjective overall ocular comfort was assessed at baseline, and at the 30-Day follow-up using a Visual Analogue Scale (VAS) ranging from 0 (extremely uncomfortable) to 100 (extremely comfortable). The change from baseline ocular comfort score was calculated as 30-Day follow-up score minus Baseline score. Change from Baseline VAS Scores range from -100 to 100, where higher change from baseline comfort scores indicates better performance. The average change from baseline comfort score for each Arm was report.
5 secondary outcomes
Change From Baseline Ocular Comfort (7-Day)
Time frame: Baseline and 7-Day Follow-up
Number of Subject Eyes That Reported Ocular Symptoms
Time frame: 7-Day Follow-up and 30-Day Follow-up
Number of Subject Eyes That Experience Grade 2 or Higher Corneal Staining
Time frame: 7-Day Follow-up and 30-Day Follow-up
Change From Baseline Ocular Vision (7-Day)
Time frame: Baseline and 7 Day-Day Follow-up
Change From Baseline Ocular Vision (30-Day)
Time frame: Baseline and 30 Day Follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39379885Donnenfeld E, Coats J, Barbour K, Ryan R, Joshi NR, Periman LM. Efficacy and safety of a lipid-containing artificial tear compared with a non-lipid containing tear: a randomized clinical trial. BMC Ophthalmol. 2024 Oct 8;24(1):442. doi: 10.1186/s12886-024-03688-z.
- 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
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 9618X investigational lipid eye drops and Blink® Tears in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site 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 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 3 Jul 2023. 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 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 14 Nov 2022). 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?
Change From Baseline Ocular Comfort (30-Day) (time frame: Baseline and 30-Day Follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03995355, which also lists 1 linked publication.
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 3 Jul 2023; AzTrials last refreshed its copy on 8 Nov 2026.