Dry Eye
Conditions
Brief summary
This is a 30-Day, multi-site, single-masked, bilateral, active- controlled, 2-Arm parallel group study to evaluate the safety and efficacy of an Investigational product.
Interventions
DRUGInvestigational Lubricating Eye Drop in a Novelia® bottle
Investigational Product
Control Product
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
Yes
Inclusion criteria
Potential subjects must satisfy all of the following criteria to be enrolled in the study: 1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. 2. Appear able and willing to adhere to the instructions set forth in this clinical protocol. 3. Be between 18 and 69 (inclusive) years of age at the time of screening. 4. Possess a wearable pair of spectacles that provide correction for distance vision and bring them to every visit (only if applicable- to the investigator's discretion). 5. Self-reported symptoms of ocular dryness and/or the use of artificial tears in the last 3 months. 6. Subjects must be non-contact lens wearers. 7. The best corrected, monocular, distance visual acuity must be 20/30 or better in each eye, either unaided or best corrected.
Exclusion criteria
Potential subjects must satisfy all of the following criteria to be enrolled in the study: 1. Be currently pregnant or lactating. 2. Be diabetic. 3. 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). 4. 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. 5. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g., SynergEyes, SoftPerm) within the past 3 months and soft contact lenses in the past 1 month. 6. Have participated in any pharmaceutical or medical device related clinical trial within 30 days prior to study enrollment. 7. 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. 8. Be a current habitual user of prescription medication to treat dry eye and ocular discomfort, ocular steroids, or any medication (RX or OTC), except for artificial tears that would interfere with the clinical study (at the discretion of the investigator). 9. 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). 10. 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). 11. Have a history of strabismus or amblyopia. 12. 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.). 13. Have any significant corneal distortion due to previous contact lens wear, surgery, or pathology (At the discretion of the investigator).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Overall Quality of Ocular Comfort From Baseline to 30-Day Follow-Up Using VAS Scores | Baseline and 30-Day Follow-up | Subjective ocular comfort was assessed at baseline, and at 30-day follow-up using a Visual Analogue Scale (VAS) with continuous scale 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 reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Overall Quality of Vision From Baseline to 30-Day Follow-Up Using VAS Scores | Baseline and 30-Day Follow-up | Subjective vision was assessed at baseline, and at 30-day follow-up using a Visual Analogue Scale (VAS) with continuous scale from 0 (extremely uncomfortable) to 100 (extremely comfortable). The change from baseline quality of 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. |
Countries
United States
Participant flow
Recruitment details
A total of 121 subjects were enrolled in this study. Of those enrolled, 118 subjects were dispensed at least one study eyedrop while 3 subjects failed to meet all eligibility criteria. Of those dispensed, 107 subjects completed the study while 11 subjects were discontinued.
Participants by arm
| Arm | Count |
|---|---|
| Test Subjects that were randomized to the Test group throughout the duration of the study. | 58 |
| Control Subjects that were randomized to the Control group throughout the duration of the study. | 60 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Covid-19 Related | 3 | 4 |
| Overall Study | investigational product Was Dispensed Incorrectly At Visit 2 | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | The Patient Was Dispensed The Incorrect investigational product At Visit 2 | 0 | 1 |
Baseline characteristics
| Characteristic | Control | Total | Test |
|---|---|---|---|
| Age, Continuous | 50.1 Years STANDARD_DEVIATION 13.79 | 49.2 Years STANDARD_DEVIATION 13.98 | 48.2 Years STANDARD_DEVIATION 14.23 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 14 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 51 Participants | 96 Participants | 45 Participants |
| Sex: Female, Male Female | 41 Participants | 86 Participants | 45 Participants |
| Sex: Female, Male Male | 19 Participants | 32 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 60 |
| other Total, other adverse events | 0 / 58 | 0 / 60 |
| serious Total, serious adverse events | 0 / 58 | 0 / 60 |
Outcome results
Primary
Change in Overall Quality of Ocular Comfort From Baseline to 30-Day Follow-Up Using VAS Scores
Subjective ocular comfort was assessed at baseline, and at 30-day follow-up using a Visual Analogue Scale (VAS) with continuous scale 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 reported.
Time frame: Baseline and 30-Day Follow-up
Population: All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Change in Overall Quality of Ocular Comfort From Baseline to 30-Day Follow-Up Using VAS Scores | 18.47 Scores on a scale | Standard Deviation 22.125 |
| Control | Change in Overall Quality of Ocular Comfort From Baseline to 30-Day Follow-Up Using VAS Scores | 9.65 Scores on a scale | Standard Deviation 22.859 |
Comparison: A sample size of 104 subjects provides at least 90% statistical power to test non-inferiority of the Test eyedrop compared to the Control eyedrop using a two sample t-test with a two-sided type I error rate of 0.05.95% CI: [-1.67, 13.38]Linear Mixed Model
Secondary
Change in Overall Quality of Vision From Baseline to 30-Day Follow-Up Using VAS Scores
Subjective vision was assessed at baseline, and at 30-day follow-up using a Visual Analogue Scale (VAS) with continuous scale from 0 (extremely uncomfortable) to 100 (extremely comfortable). The change from baseline quality of 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.
Time frame: Baseline and 30-Day Follow-up
Population: All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Change in Overall Quality of Vision From Baseline to 30-Day Follow-Up Using VAS Scores | 11.55 Scores on a scale | Standard Deviation 22.863 |
| Control | Change in Overall Quality of Vision From Baseline to 30-Day Follow-Up Using VAS Scores | 5.70 Scores on a scale | Standard Deviation 23.615 |
Comparison: A sample size of 104 subjects provides at least 90% statistical power to test non-inferiority of the Test eyedrop compared to the Control eyedrop using a two sample t-test with a two-sided type I error rate of 0.05.95% CI: [-2.8904, 14.5768]Bootstrapping methods