Refractive Error - Myopia Bilateral
Conditions
Brief summary
This clinical study is to provide clinical performance data comparing the test lens (Deseyne \[vifilcon C\] daily disposable soft contact lens) to a control lens (1-Day Acuvue Moist \[etafilcon A\] daily disposable soft contact lens) in the same indication for use (single use prior to removal followed by a fresh lens upon the next lens wear exposure). The study is designed to test the hypothesis that the test lens is substantially equivalent to the control lens in like indications for use.
Detailed description
A multicenter, randomized, active-controlled, open-label study design will be used to compare the clinical performance of the Deseyne (vifilcon C) test soft contact lens to the similarly indicated 1-Day Acuvue® Moist® (etafilcon A) control soft contact lens. Study participation is approximately 90 days in duration and will consist of approximately 80 subjects assigned in a 2:1 ratio to test or control lens bilaterally, respectively. Subjects must be otherwise healthy, with myopia between -1.00 D and -6.00 D and astigmatism no greater than 1.00 D that does not interfere with VA. At the Screening Visit, approximately two-thirds of the eligible subjects will be randomized to receive the test lens (Deseyne \[vifilcon C\] lenses) and the other one-third eligible subjects will be randomized to receive the control lens (1-Day Acuvue Moist \[etafilcon A\] lenses). At the Dispensing Visit (Visit 2), subjects will be provided with test or control lenses as part of the dispensing package, along with instructions for the use and care of the lenses. They will be recommended unpreserved lubricating/rewetting solution for use as needed during the study. Subjects will wear their assigned lenses bilaterally on a daily wear basis, for a minimum of 6 hours/day throughout the study (no maximum time is mandated, as long as subjects do not sleep in their lenses), with additional visits planned for 1 Week (Visit 3), 1 Month (Visit 4), 2 Months (Visit 5), and 3 Months/Exit Visit (Visit 6). This study follows United States Food and Drug Administration (FDA) Premarket Notification 510(k) Guidance for Daily Wear Contact Lenses adopted in May 1994, and any unpublished subsequent policy declarations.
Interventions
DEVICEDeseyne Daily Disposable Contact Lens (Test Device)
Comparison of contact lens performance between the test lens under study (Deseyne Daily Disposable Contact Lens) and the control lens f(1-Day Acuvue Moist Contact Lens) for safety and effectiveness.
Sponsors
Bruno Vision Care
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Masking description
Open label randomization assignment between test and control intervention.
Intervention model description
Comparison of a test contact lens performance to a known, cleared for market contact lens.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. 18 to 40 years of age on the date the informed consent form (ICF) is signed 2. Presence of clear central corneas and absence of any anterior segment disorders in each eye 3. Presence of myopia and requirement for lens correction from -1.00 D to -6.00 D in each eye 4. Best-corrected distance visual acuity (BCDVA) of 50 ETDRS letters (0.1 logMAR) or better in each eye 5. Be an adapted soft contact lens wearer in each eye and agree to wear study lenses in each eye on a daily wear basis and not wear a non-study lens for approximately 3 months 6. Able and willing to comply with all treatment and follow-up/study procedures 7. Able to read, understand, and provide written informed consent on the IRB-approved ICF and provide authorization as appropriate for local privacy regulations
Exclusion criteria
1. Participation in any drug or device clinical investigation within 2 weeks prior to Screening and/or during the period of study participation 2. Women of childbearing potential (those who are not surgically sterilized or postmenopausal) who meet any of the following conditions: 1. Currently pregnant 2. Plans to become pregnant during the study 3. Currently breastfeeding 3. History of gas permeable lens wear in either eye within 30 days prior to Screening or history of polymethylmethacrylate lens wear in either eye within 3 months prior to Screening 4. Current monovision, multifocal, or toric contact lens wear in either eye 5. In either eye, current nonabsorbable punctal plug or implantation of absorbable punctal plug within 2 to 6 months (depending on type of absorbable plug) prior to Screening, or punctal plug removal within 2 months prior to Screening. Permanent punctal occlusion in 1 or more puncta or nasolacrimal duct obstruction in either eye is excluded 6. Use of any prescription ocular medication throughout the duration of the study. Prescription eyedrops for dry eye disease (eg, Restasis, Xiidra, Cequa, Eysuvis), as well as nasally administered Tyrvaya, must be discontinued 2 weeks prior to Screening and are prohibited throughout the duration of the study Clinical Study Protocol Version 3.0, 26 April 2023 Page 17 of 66 Bruno Vision Care Protocol 22001 7. Use of over-the-counter eyedrops (eg, oxymetazoline, naphazoline, ketotifen, etc.), except for unpreserved lubricant eyedrops or artificial tears (eg, Systane, Refresh), within 1 week prior to Screening and throughout the duration of the study 8. Use of any systemic or topical medications that may, in the Investigator's opinion, affect ocular physiology or lens performance 9. Anisometropia (spherical equivalent) \>2.00 D 10. Ocular astigmatism \>1.00 D in either eye 11. Amblyopia in either eye 12. Aphakia in either eye 13. Active ocular disease (eg, dry eye disease, blepharitis, conjunctivitis, keratitis, etc.) in either eye. Subjects must be symptom free for at least 7 days 14. History or evidence of ocular infection within 30 days prior to Screening 15. History or evidence of ocular herpes simplex or ocular herpes zoster 16. Any grade corneal infiltrates in either eye 17. Grade ≥2 finding in either eye during slit lamp examination 18. Any Present finding in either eye during slit lamp examination that, in the Investigator's opinion, may interfere with contact lens wear 19. Any scar or neovascularization within the central 4 mm of the cornea in either eye. Subjects with minor peripheral corneal scarring (not extending into the central area) that, in the Investigator's opinion, does not interfere with contact lens wear are eligible to participate in this study 20. History of any corneal surgery (eg, refractive surgery or therapeutic) in either eye 21. Any systemic disease currently affecting ocular health or which, in the Investigator's opinion, may have an effect on ocular health in either eye during the course of the study 22. Allergy to any component in the study care products 23. Meet any of the following criteria: 1. Subject is an employee of the investigative site 2. Subject or a member of the subject's household is an ophthalmologist, an optometrist, an optician, or an ophthalmic assistant/technician 3. Subject or a member of the subject's household is an employee of a manufacturer of contact lenses or contact lens care products 4. Subject or a member of the subject's household is an employee of a market research firm -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Each Post-Baseline Visit in Distance logMAR Visual Acuity (Letters Read) by Eye | Baseline, Day 1, Week 1, Month 1, Month 2, Month 3 | To assess each eye for the change from baseline to each post-baseline visit in distance logMAR VA (letters read) |
| Number and Percentage of Subjects With No More Than 5 Letters Read Loss From Baseline | Day 1, Week 1, Month 1, Month 2, Month 3 | To assess the number and percentage of subjects with no more than 5 letters read loss from baseline |
| Slit Lamp Findings Grade >2 at Any Follow-Up Visit | 3 months | To assess the following slit lamp findings: epithelial edema, epithelial microcysts, limbal injection, bulbar injection, upper lid tarsal conjunctival, corneal neovascularization, and corneal infiltrates |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms/Complaints | Month 3 | This unnamed questionnaire measures change from baseline in discomfort, excessive tearing, photophobia, halos, itching/burning/spectacle blur, variable vision, blurred vision, lens needs cleaning, handling using a 0 (no symptoms) to 4 (severe symptoms) scale for each symptom |
| Lens Wettability, Centration, and Movement | 3 months | Wettability Analog Scale 0-4 (0=100% wettable, 4=more than one dry spot greater than 0.5 mm) Lower score is better Centration Analog Scale 0-4 (0=superior cornea, 4=inferior cornea) Lower score is better Movement Analog Scale 0-4 (0=adequate, 4=adherence to cornea) Lower score is better |
| Lens Deposits | 3 months | To assess type of deposit |
Countries
United States
Participant flow
Recruitment details
81 subjects enrolled in the study for a period of 3 months follow-up. Study began on April 8, 2023 at three clinical sites and was completed on January 8, 2024. All sites were at private clinical optometric sites.. Each site conducted screening evaluation to determine eligibility for continuation in the study. Follow-up visits were scheduled at 1 week, 1 month, 2 months, and 3 months including he exit visit. Subjects were instructed to wear the contact lenses a minimum of 6 hours per day.
Pre-assignment details
The study was designed as a randomized enrollment dictated by an electronic randomization program to test and control. This assignment took place at the screening visit at each site. All subjects were subject to review for inclusion and exclusion at enrollment screening visit. To be included/excluded all screening needed to meet all criteria by forced choice selection. Any positive exclusion element excluded the subject from continuing with participation.
Participants by arm
| Arm | Count |
|---|---|
| Test Lens. Deseyne Daily Disposable Contact Lens Test contact lens to be worn as a daily disposable soft (hydrophilic) contact lens, to be discarded daily. Individual new lens placed daily for a period of 90 consecutive days, bilaterally. Follow-up visits are 1 week, 1 month, 2 months, and 3 months after dispensing.
Deseyne Daily Disposable Contact Lens (Test Device): Comparison of contact lens performance between the test lens under study (Deseyne Daily Disposable Contact Lens) and the control lens f(1-Day Acuvue Moist Contact Lens) for safety and effectiveness. | 53 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens Control lens to be worn as a daily disposable soft (hydrophilic) contact lens, to be discarded daily, Individual new lens placed daily for a period of 90 consecutive days, bilaterally. Follow-up visits are 1 week, 1 month, 2 months, and 3 months after dispensing.
Deseyne Daily Disposable Contact Lens (Test Device): Comparison of contact lens performance between the test lens under study (Deseyne Daily Disposable Contact Lens) and the control lens f(1-Day Acuvue Moist Contact Lens) for safety and effectiveness. | 28 |
| Total | 81 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Total | Test Lens. Deseyne Daily Disposable Contact Lens | Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 81 Participants | 53 Participants | 28 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 70 Participants | 47 Participants | 23 Participants |
| Region of Enrollment United States | 81 participants | 53 participants | 28 participants |
| Sex: Female, Male Female | 57 Participants | 39 Participants | 18 Participants |
| Sex: Female, Male Male | 24 Participants | 14 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 26 |
| other Total, other adverse events | 3 / 53 | 1 / 26 |
| serious Total, serious adverse events | 0 / 53 | 0 / 26 |
Outcome results
Primary
Change From Baseline to Each Post-Baseline Visit in Distance logMAR Visual Acuity (Letters Read) by Eye
To assess each eye for the change from baseline to each post-baseline visit in distance logMAR VA (letters read)
Time frame: Baseline, Day 1, Week 1, Month 1, Month 2, Month 3
Population: Each row refers to either right eyes (OD) or left eyes (OS); therefore, the number of eyes analyzed is one-half of the total eyes in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Lens. Deseyne Daily Disposable Contact Lens | Change From Baseline to Each Post-Baseline Visit in Distance logMAR Visual Acuity (Letters Read) by Eye | Change from baseline at Day 1 OD | 0.3 letters read | Standard Deviation 2.76 |
| Test Lens. Deseyne Daily Disposable Contact Lens | Change From Baseline to Each Post-Baseline Visit in Distance logMAR Visual Acuity (Letters Read) by Eye | Change from baseline at Day 1 OS | -0.0 letters read | Standard Deviation 2.19 |
| Test Lens. Deseyne Daily Disposable Contact Lens | Change From Baseline to Each Post-Baseline Visit in Distance logMAR Visual Acuity (Letters Read) by Eye | Change from baseline at Week 1 OS | -0.1 letters read | Standard Deviation 2.79 |
| Test Lens. Deseyne Daily Disposable Contact Lens | Change From Baseline to Each Post-Baseline Visit in Distance logMAR Visual Acuity (Letters Read) by Eye | Change from baseline at Month 2 OD | 0.7 letters read | Standard Deviation 2.85 |
| Test Lens. Deseyne Daily Disposable Contact Lens | Change From Baseline to Each Post-Baseline Visit in Distance logMAR Visual Acuity (Letters Read) by Eye | Change from baseline at Month 1 OS | 0.3 letters read | Standard Deviation 2.17 |
| Test Lens. Deseyne Daily Disposable Contact Lens | Change From Baseline to Each Post-Baseline Visit in Distance logMAR Visual Acuity (Letters Read) by Eye | Change from baseline at Month 1 OD | 0.5 letters read | Standard Deviation 2.71 |
| Test Lens. Deseyne Daily Disposable Contact Lens | Change From Baseline to Each Post-Baseline Visit in Distance logMAR Visual Acuity (Letters Read) by Eye | Change from baseline at Month 2 OS | 0.3 letters read | Standard Deviation 2.7 |
| Test Lens. Deseyne Daily Disposable Contact Lens | Change From Baseline to Each Post-Baseline Visit in Distance logMAR Visual Acuity (Letters Read) by Eye | Change from baseline at Month 3 OD | 0.3 letters read | Standard Deviation 3.14 |
| Test Lens. Deseyne Daily Disposable Contact Lens | Change From Baseline to Each Post-Baseline Visit in Distance logMAR Visual Acuity (Letters Read) by Eye | Change from baseline at Month 3 OS | -0.1 letters read | Standard Deviation 2.84 |
| Test Lens. Deseyne Daily Disposable Contact Lens | Change From Baseline to Each Post-Baseline Visit in Distance logMAR Visual Acuity (Letters Read) by Eye | Change from baseline at Week 1 OD | 0.4 letters read | Standard Deviation 2.55 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Change From Baseline to Each Post-Baseline Visit in Distance logMAR Visual Acuity (Letters Read) by Eye | Change from baseline at Month 3 OS | 0.5 letters read | Standard Deviation 2.52 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Change From Baseline to Each Post-Baseline Visit in Distance logMAR Visual Acuity (Letters Read) by Eye | Change from baseline at Week 1 OD | 0.4 letters read | Standard Deviation 1.94 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Change From Baseline to Each Post-Baseline Visit in Distance logMAR Visual Acuity (Letters Read) by Eye | Change from baseline at Day 1 OS | 0.2 letters read | Standard Deviation 2.56 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Change From Baseline to Each Post-Baseline Visit in Distance logMAR Visual Acuity (Letters Read) by Eye | Change from baseline at Day 1 OD | 0.0 letters read | Standard Deviation 2.47 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Change From Baseline to Each Post-Baseline Visit in Distance logMAR Visual Acuity (Letters Read) by Eye | Change from baseline at Month 1 OD | 0.4 letters read | Standard Deviation 2.83 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Change From Baseline to Each Post-Baseline Visit in Distance logMAR Visual Acuity (Letters Read) by Eye | Change from baseline at Month 2 OD | 0.5 letters read | Standard Deviation 2.38 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Change From Baseline to Each Post-Baseline Visit in Distance logMAR Visual Acuity (Letters Read) by Eye | Change from baseline at Month 3 OD | -0.4 letters read | Standard Deviation 2.81 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Change From Baseline to Each Post-Baseline Visit in Distance logMAR Visual Acuity (Letters Read) by Eye | Change from baseline at Week 1 OS | 0.5 letters read | Standard Deviation 2.12 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Change From Baseline to Each Post-Baseline Visit in Distance logMAR Visual Acuity (Letters Read) by Eye | Change from baseline at Month 1 OS | 0.4 letters read | Standard Deviation 2.86 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Change From Baseline to Each Post-Baseline Visit in Distance logMAR Visual Acuity (Letters Read) by Eye | Change from baseline at Month 2 OS | 0.8 letters read | Standard Deviation 2.58 |
Primary
Number and Percentage of Subjects With No More Than 5 Letters Read Loss From Baseline
To assess the number and percentage of subjects with no more than 5 letters read loss from baseline
Time frame: Day 1, Week 1, Month 1, Month 2, Month 3
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test Lens. Deseyne Daily Disposable Contact Lens | Number and Percentage of Subjects With No More Than 5 Letters Read Loss From Baseline | Day 1 OS | 100 percentage of subjects |
| Test Lens. Deseyne Daily Disposable Contact Lens | Number and Percentage of Subjects With No More Than 5 Letters Read Loss From Baseline | Week 1 OS | 98.1 percentage of subjects |
| Test Lens. Deseyne Daily Disposable Contact Lens | Number and Percentage of Subjects With No More Than 5 Letters Read Loss From Baseline | Month 1 OD | 98.1 percentage of subjects |
| Test Lens. Deseyne Daily Disposable Contact Lens | Number and Percentage of Subjects With No More Than 5 Letters Read Loss From Baseline | Month 1 OS | 100 percentage of subjects |
| Test Lens. Deseyne Daily Disposable Contact Lens | Number and Percentage of Subjects With No More Than 5 Letters Read Loss From Baseline | Day 1 OD | 98.1 percentage of subjects |
| Test Lens. Deseyne Daily Disposable Contact Lens | Number and Percentage of Subjects With No More Than 5 Letters Read Loss From Baseline | Month 2 OS | 100 percentage of subjects |
| Test Lens. Deseyne Daily Disposable Contact Lens | Number and Percentage of Subjects With No More Than 5 Letters Read Loss From Baseline | Month 2 OD | 98.1 percentage of subjects |
| Test Lens. Deseyne Daily Disposable Contact Lens | Number and Percentage of Subjects With No More Than 5 Letters Read Loss From Baseline | Month 3 OS | 98.1 percentage of subjects |
| Test Lens. Deseyne Daily Disposable Contact Lens | Number and Percentage of Subjects With No More Than 5 Letters Read Loss From Baseline | Week 1 OD | 100 percentage of subjects |
| Test Lens. Deseyne Daily Disposable Contact Lens | Number and Percentage of Subjects With No More Than 5 Letters Read Loss From Baseline | Month 3 OD | 94.3 percentage of subjects |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Number and Percentage of Subjects With No More Than 5 Letters Read Loss From Baseline | Month 3 OS | 96.0 percentage of subjects |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Number and Percentage of Subjects With No More Than 5 Letters Read Loss From Baseline | Week 1 OD | 100 percentage of subjects |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Number and Percentage of Subjects With No More Than 5 Letters Read Loss From Baseline | Month 1 OD | 96.0 percentage of subjects |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Number and Percentage of Subjects With No More Than 5 Letters Read Loss From Baseline | Month 2 OD | 100 percentage of subjects |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Number and Percentage of Subjects With No More Than 5 Letters Read Loss From Baseline | Day 1 OS | 96.2 percentage of subjects |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Number and Percentage of Subjects With No More Than 5 Letters Read Loss From Baseline | Week 1 OS | 100 percentage of subjects |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Number and Percentage of Subjects With No More Than 5 Letters Read Loss From Baseline | Month 1 OS | 96.0 percentage of subjects |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Number and Percentage of Subjects With No More Than 5 Letters Read Loss From Baseline | Month 2 OS | 96.0 percentage of subjects |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Number and Percentage of Subjects With No More Than 5 Letters Read Loss From Baseline | Day 1 OD | 100 percentage of subjects |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Number and Percentage of Subjects With No More Than 5 Letters Read Loss From Baseline | Month 3 OD | 96.0 percentage of subjects |
Primary
Slit Lamp Findings Grade >2 at Any Follow-Up Visit
To assess the following slit lamp findings: epithelial edema, epithelial microcysts, limbal injection, bulbar injection, upper lid tarsal conjunctival, corneal neovascularization, and corneal infiltrates
Time frame: 3 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Test Lens. Deseyne Daily Disposable Contact Lens | Slit Lamp Findings Grade >2 at Any Follow-Up Visit | No slit lamp findings Grade >2 | 53 Participants |
| Test Lens. Deseyne Daily Disposable Contact Lens | Slit Lamp Findings Grade >2 at Any Follow-Up Visit | Any slit lamp findings Grade >2 | 0 Participants |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Slit Lamp Findings Grade >2 at Any Follow-Up Visit | Any slit lamp findings Grade >2 | 0 Participants |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Slit Lamp Findings Grade >2 at Any Follow-Up Visit | No slit lamp findings Grade >2 | 26 Participants |
Secondary
Lens Deposits
To assess type of deposit
Time frame: 3 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Test Lens. Deseyne Daily Disposable Contact Lens | Lens Deposits | No deposits | 51 Participants |
| Test Lens. Deseyne Daily Disposable Contact Lens | Lens Deposits | Film | 0 Participants |
| Test Lens. Deseyne Daily Disposable Contact Lens | Lens Deposits | Spots | 2 Participants |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Lens Deposits | No deposits | 22 Participants |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Lens Deposits | Film | 1 Participants |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Lens Deposits | Spots | 2 Participants |
Secondary
Lens Wettability, Centration, and Movement
Wettability Analog Scale 0-4 (0=100% wettable, 4=more than one dry spot greater than 0.5 mm) Lower score is better Centration Analog Scale 0-4 (0=superior cornea, 4=inferior cornea) Lower score is better Movement Analog Scale 0-4 (0=adequate, 4=adherence to cornea) Lower score is better
Time frame: 3 months
Population: Each row analyzes either right eyes (OS) or left eyes (OS); therefore, the total number of eyes in a row is one-half of the total eye population for that arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Lens. Deseyne Daily Disposable Contact Lens | Lens Wettability, Centration, and Movement | Change from baseline in wettability OD | 0.1 units on a scale | Standard Deviation 0.32 |
| Test Lens. Deseyne Daily Disposable Contact Lens | Lens Wettability, Centration, and Movement | Change from baseline in wettability OS | 0.1 units on a scale | Standard Deviation 0.32 |
| Test Lens. Deseyne Daily Disposable Contact Lens | Lens Wettability, Centration, and Movement | Change from baseline in centration OD | 0.1 units on a scale | Standard Deviation 0.36 |
| Test Lens. Deseyne Daily Disposable Contact Lens | Lens Wettability, Centration, and Movement | Change from baseline in centration OS | 0.1 units on a scale | Standard Deviation 0.4 |
| Test Lens. Deseyne Daily Disposable Contact Lens | Lens Wettability, Centration, and Movement | Change from baseline in movement OD | 0.0 units on a scale | Standard Deviation 0.39 |
| Test Lens. Deseyne Daily Disposable Contact Lens | Lens Wettability, Centration, and Movement | Change from baseline in movement OS | 0.1 units on a scale | Standard Deviation 0.45 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Lens Wettability, Centration, and Movement | Change from baseline in centration OD | 0.0 units on a scale | Standard Deviation 0.61 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Lens Wettability, Centration, and Movement | Change from baseline in wettability OD | 0.1 units on a scale | Standard Deviation 0.33 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Lens Wettability, Centration, and Movement | Change from baseline in movement OD | 0.0 units on a scale | Standard Deviation 0.35 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Lens Wettability, Centration, and Movement | Change from baseline in wettability OS | 0.1 units on a scale | Standard Deviation 0.28 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Lens Wettability, Centration, and Movement | Change from baseline in centration OS | 0.0 units on a scale | Standard Deviation 0.73 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Lens Wettability, Centration, and Movement | Change from baseline in movement OS | 0.0 units on a scale | Standard Deviation 0.35 |
Secondary
Symptoms/Complaints
This unnamed questionnaire measures change from baseline in discomfort, excessive tearing, photophobia, halos, itching/burning/spectacle blur, variable vision, blurred vision, lens needs cleaning, handling using a 0 (no symptoms) to 4 (severe symptoms) scale for each symptom
Time frame: Month 3
Population: Each row analyzes either right eyes (OD) or left eyes (OS); therefore, the number of eyes analyzed is one-half of the total eye population in that arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Lens. Deseyne Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in blurred vision OD | 0.0 units on a scale | Standard Deviation 0.19 |
| Test Lens. Deseyne Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in handling OS | 0.6 units on a scale | Standard Deviation 1.05 |
| Test Lens. Deseyne Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in halos OD | 0.0 units on a scale | Standard Deviation 0 |
| Test Lens. Deseyne Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in excessive tearing OD | 0.0 units on a scale | Standard Deviation 0 |
| Test Lens. Deseyne Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in itching/burning OD | -0.0 units on a scale | Standard Deviation 0.5 |
| Test Lens. Deseyne Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in discomfort OS | 0.6 units on a scale | Standard Deviation 0.79 |
| Test Lens. Deseyne Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in itching/burning OS | 0.0 units on a scale | Standard Deviation 0.52 |
| Test Lens. Deseyne Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in halos OS | 0.0 units on a scale | Standard Deviation 0 |
| Test Lens. Deseyne Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in spectacle blur OD | 0.0 units on a scale | Standard Deviation 0 |
| Test Lens. Deseyne Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in variable vision OD | 0.1 units on a scale | Standard Deviation 0.45 |
| Test Lens. Deseyne Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in photophobia OD | 0.0 units on a scale | Standard Deviation 0 |
| Test Lens. Deseyne Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in discomfort OD | 0.6 units on a scale | Standard Deviation 0.8 |
| Test Lens. Deseyne Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in blurred vision OS | 0.1 units on a scale | Standard Deviation 0.33 |
| Test Lens. Deseyne Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in spectacle blur OS | 0.0 units on a scale | Standard Deviation 0 |
| Test Lens. Deseyne Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in lens needs cleaning OD | 0.0 units on a scale | Standard Deviation 0.19 |
| Test Lens. Deseyne Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in photophobia OS | 0.0 units on a scale | Standard Deviation 0 |
| Test Lens. Deseyne Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in lens needs cleaning OS | 0.0 units on a scale | Standard Deviation 0.19 |
| Test Lens. Deseyne Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in variable vision OS | 0.1 units on a scale | Standard Deviation 0.45 |
| Test Lens. Deseyne Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in handling OD | 0.5 units on a scale | Standard Deviation 1.07 |
| Test Lens. Deseyne Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in excessive tearing OS | 0.0 units on a scale | Standard Deviation 0 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in handling OD | 0.4 units on a scale | Standard Deviation 0.87 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in discomfort OD | 0.4 units on a scale | Standard Deviation 0.96 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in discomfort OS | 0.4 units on a scale | Standard Deviation 0.96 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in excessive tearing OS | 0.0 units on a scale | Standard Deviation 0 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in photophobia OD | -0.1 units on a scale | Standard Deviation 0.4 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in photophobia OS | -0.1 units on a scale | Standard Deviation 0.41 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in halos OD | -0.1 units on a scale | Standard Deviation 0.4 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in halos OS | -0.1 units on a scale | Standard Deviation 0.41 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in spectacle blur OD | 0.0 units on a scale | Standard Deviation 0 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in spectacle blur OS | 0.0 units on a scale | Standard Deviation 0 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in variable vision OS | 0.1 units on a scale | Standard Deviation 0.28 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in handling OS | 0.5 units on a scale | Standard Deviation 0.88 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in itching/burning OD | 0.1 units on a scale | Standard Deviation 0.4 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in itching/burning OS | 0.1 units on a scale | Standard Deviation 0.5 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in variable vision OD | 0.1 units on a scale | Standard Deviation 0.28 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in blurred vision OD | 0.2 units on a scale | Standard Deviation 0.62 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in blurred vision OS | 0.2 units on a scale | Standard Deviation 0.62 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in lens needs cleaning OD | -0.0 units on a scale | Standard Deviation 0.2 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in lens needs cleaning OS | -0.0 units on a scale | Standard Deviation 0.2 |
| Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens | Symptoms/Complaints | Change from baseline in excessive tearing OD | 0.0 units on a scale | Standard Deviation 0 |