Trial Outcomes & Findings for Study to Evaluate the Clinical Performance of Deseyne (Vifilcon C) Daily Disposable Soft Contact Lens (NCT NCT05927753)
NCT ID: NCT05927753
Last Updated: 2025-10-02
Results Overview
To assess each eye for the change from baseline to each post-baseline visit in distance logMAR VA (letters read)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
81 participants
Primary outcome timeframe
Baseline, Day 1, Week 1, Month 1, Month 2, Month 3
Results posted on
2025-10-02
Participant Flow
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.
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.
Unit of analysis: eyes
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
53 106
|
28 56
|
|
Overall Study
COMPLETED
|
53 106
|
25 50
|
|
Overall Study
NOT COMPLETED
|
0 0
|
3 6
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Study to Evaluate the Clinical Performance of Deseyne (Vifilcon C) Daily Disposable Soft Contact Lens
Baseline characteristics by cohort
| Measure |
Test Lens. Deseyne Daily Disposable Contact Lens
n=53 Participants
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.
|
Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens
n=28 Participants
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.
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
53 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=5 Participants
|
28 participants
n=7 Participants
|
81 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 1, Week 1, Month 1, Month 2, Month 3Population: 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.
To assess each eye for the change from baseline to each post-baseline visit in distance logMAR VA (letters read)
Outcome measures
| Measure |
Test Lens. Deseyne Daily Disposable Contact Lens
n=106 eyes
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.
|
Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens
n=56 eyes
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.
|
|---|---|---|
|
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
|
0.0 letters read
Standard Deviation 2.47
|
|
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
|
0.4 letters read
Standard Deviation 1.94
|
|
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
|
0.4 letters read
Standard Deviation 2.83
|
|
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
|
0.5 letters read
Standard Deviation 2.38
|
|
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
|
-0.4 letters read
Standard Deviation 2.81
|
|
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
|
0.2 letters read
Standard Deviation 2.56
|
|
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
|
0.5 letters read
Standard Deviation 2.12
|
|
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
|
0.4 letters read
Standard Deviation 2.86
|
|
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 2.70
|
0.8 letters read
Standard Deviation 2.58
|
|
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
|
0.5 letters read
Standard Deviation 2.52
|
PRIMARY outcome
Timeframe: Day 1, Week 1, Month 1, Month 2, Month 3To assess the number and percentage of subjects with no more than 5 letters read loss from baseline
Outcome measures
| Measure |
Test Lens. Deseyne Daily Disposable Contact Lens
n=53 Participants
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.
|
Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens
n=28 Participants
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.
|
|---|---|---|
|
Number and Percentage of Subjects With No More Than 5 Letters Read Loss From Baseline
Day 1 OD
|
98.1 percentage of subjects
|
100 percentage of subjects
|
|
Number and Percentage of Subjects With No More Than 5 Letters Read Loss From Baseline
Week 1 OD
|
100 percentage of subjects
|
100 percentage of subjects
|
|
Number and Percentage of Subjects With No More Than 5 Letters Read Loss From Baseline
Month 1 OD
|
98.1 percentage of subjects
|
96.0 percentage of subjects
|
|
Number and Percentage of Subjects With No More Than 5 Letters Read Loss From Baseline
Month 2 OD
|
98.1 percentage of subjects
|
100 percentage of subjects
|
|
Number and Percentage of Subjects With No More Than 5 Letters Read Loss From Baseline
Month 3 OD
|
94.3 percentage of subjects
|
96.0 percentage of subjects
|
|
Number and Percentage of Subjects With No More Than 5 Letters Read Loss From Baseline
Day 1 OS
|
100 percentage of subjects
|
96.2 percentage of subjects
|
|
Number and Percentage of Subjects With No More Than 5 Letters Read Loss From Baseline
Week 1 OS
|
98.1 percentage of subjects
|
100 percentage of subjects
|
|
Number and Percentage of Subjects With No More Than 5 Letters Read Loss From Baseline
Month 1 OS
|
100 percentage of subjects
|
96.0 percentage of subjects
|
|
Number and Percentage of Subjects With No More Than 5 Letters Read Loss From Baseline
Month 2 OS
|
100 percentage of subjects
|
96.0 percentage of subjects
|
|
Number and Percentage of Subjects With No More Than 5 Letters Read Loss From Baseline
Month 3 OS
|
98.1 percentage of subjects
|
96.0 percentage of subjects
|
PRIMARY outcome
Timeframe: 3 monthsTo assess the following slit lamp findings: epithelial edema, epithelial microcysts, limbal injection, bulbar injection, upper lid tarsal conjunctival, corneal neovascularization, and corneal infiltrates
Outcome measures
| Measure |
Test Lens. Deseyne Daily Disposable Contact Lens
n=53 Participants
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.
|
Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens
n=26 Participants
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.
|
|---|---|---|
|
Slit Lamp Findings Grade >2 at Any Follow-Up Visit
Any slit lamp findings Grade >2
|
0 Participants
|
0 Participants
|
|
Slit Lamp Findings Grade >2 at Any Follow-Up Visit
No slit lamp findings Grade >2
|
53 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Month 3Population: 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
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
Outcome measures
| Measure |
Test Lens. Deseyne Daily Disposable Contact Lens
n=106 eyes
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.
|
Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens
n=56 eyes
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.
|
|---|---|---|
|
Symptoms/Complaints
Change from baseline in discomfort OD
|
0.6 units on a scale
Standard Deviation 0.80
|
0.4 units on a scale
Standard Deviation 0.96
|
|
Symptoms/Complaints
Change from baseline in discomfort OS
|
0.6 units on a scale
Standard Deviation 0.79
|
0.4 units on a scale
Standard Deviation 0.96
|
|
Symptoms/Complaints
Change from baseline in excessive tearing OD
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
|
Symptoms/Complaints
Change from baseline in excessive tearing OS
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
|
Symptoms/Complaints
Change from baseline in photophobia OD
|
0.0 units on a scale
Standard Deviation 0.00
|
-0.1 units on a scale
Standard Deviation 0.40
|
|
Symptoms/Complaints
Change from baseline in photophobia OS
|
0.0 units on a scale
Standard Deviation 0.00
|
-0.1 units on a scale
Standard Deviation 0.41
|
|
Symptoms/Complaints
Change from baseline in halos OD
|
0.0 units on a scale
Standard Deviation 0.00
|
-0.1 units on a scale
Standard Deviation 0.40
|
|
Symptoms/Complaints
Change from baseline in halos OS
|
0.0 units on a scale
Standard Deviation 0.00
|
-0.1 units on a scale
Standard Deviation 0.41
|
|
Symptoms/Complaints
Change from baseline in itching/burning OD
|
-0.0 units on a scale
Standard Deviation 0.50
|
0.1 units on a scale
Standard Deviation 0.40
|
|
Symptoms/Complaints
Change from baseline in itching/burning OS
|
0.0 units on a scale
Standard Deviation 0.52
|
0.1 units on a scale
Standard Deviation 0.50
|
|
Symptoms/Complaints
Change from baseline in spectacle blur OD
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
|
Symptoms/Complaints
Change from baseline in spectacle blur OS
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
|
Symptoms/Complaints
Change from baseline in variable vision OD
|
0.1 units on a scale
Standard Deviation 0.45
|
0.1 units on a scale
Standard Deviation 0.28
|
|
Symptoms/Complaints
Change from baseline in variable vision OS
|
0.1 units on a scale
Standard Deviation 0.45
|
0.1 units on a scale
Standard Deviation 0.28
|
|
Symptoms/Complaints
Change from baseline in blurred vision OD
|
0.0 units on a scale
Standard Deviation 0.19
|
0.2 units on a scale
Standard Deviation 0.62
|
|
Symptoms/Complaints
Change from baseline in blurred vision OS
|
0.1 units on a scale
Standard Deviation 0.33
|
0.2 units on a scale
Standard Deviation 0.62
|
|
Symptoms/Complaints
Change from baseline in lens needs cleaning OD
|
0.0 units on a scale
Standard Deviation 0.19
|
-0.0 units on a scale
Standard Deviation 0.20
|
|
Symptoms/Complaints
Change from baseline in lens needs cleaning OS
|
0.0 units on a scale
Standard Deviation 0.19
|
-0.0 units on a scale
Standard Deviation 0.20
|
|
Symptoms/Complaints
Change from baseline in handling OD
|
0.5 units on a scale
Standard Deviation 1.07
|
0.4 units on a scale
Standard Deviation 0.87
|
|
Symptoms/Complaints
Change from baseline in handling OS
|
0.6 units on a scale
Standard Deviation 1.05
|
0.5 units on a scale
Standard Deviation 0.88
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 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.
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
Outcome measures
| Measure |
Test Lens. Deseyne Daily Disposable Contact Lens
n=106 eyes
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.
|
Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens
n=56 eyes
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.
|
|---|---|---|
|
Lens Wettability, Centration, and Movement
Change from baseline in wettability OD
|
0.1 units on a scale
Standard Deviation 0.32
|
0.1 units on a scale
Standard Deviation 0.33
|
|
Lens Wettability, Centration, and Movement
Change from baseline in wettability OS
|
0.1 units on a scale
Standard Deviation 0.32
|
0.1 units on a scale
Standard Deviation 0.28
|
|
Lens Wettability, Centration, and Movement
Change from baseline in centration OD
|
0.1 units on a scale
Standard Deviation 0.36
|
0.0 units on a scale
Standard Deviation 0.61
|
|
Lens Wettability, Centration, and Movement
Change from baseline in centration OS
|
0.1 units on a scale
Standard Deviation 0.40
|
0.0 units on a scale
Standard Deviation 0.73
|
|
Lens Wettability, Centration, and Movement
Change from baseline in movement OD
|
0.0 units on a scale
Standard Deviation 0.39
|
0.0 units on a scale
Standard Deviation 0.35
|
|
Lens Wettability, Centration, and Movement
Change from baseline in movement OS
|
0.1 units on a scale
Standard Deviation 0.45
|
0.0 units on a scale
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: 3 monthsTo assess type of deposit
Outcome measures
| Measure |
Test Lens. Deseyne Daily Disposable Contact Lens
n=53 Participants
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.
|
Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens
n=25 Participants
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.
|
|---|---|---|
|
Lens Deposits
No deposits
|
51 Participants
|
22 Participants
|
|
Lens Deposits
Film
|
0 Participants
|
1 Participants
|
|
Lens Deposits
Spots
|
2 Participants
|
2 Participants
|
Adverse Events
Test Lens. Deseyne Daily Disposable Contact Lens
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Lens. Deseyne Daily Disposable Contact Lens
n=53 participants at risk
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.
|
Control Lens. 1-Day Acuvue Moist Daily Disposable Contact Lens
n=26 participants at risk
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.
|
|---|---|---|
|
Eye disorders
Contact lens intolerance
|
0.00%
0/53 • 3 months
Treatment-emergent adverse events using system organ class and preferred terms
|
3.8%
1/26 • Number of events 2 • 3 months
Treatment-emergent adverse events using system organ class and preferred terms
|
|
Eye disorders
Vision blurred
|
0.00%
0/53 • 3 months
Treatment-emergent adverse events using system organ class and preferred terms
|
3.8%
1/26 • Number of events 2 • 3 months
Treatment-emergent adverse events using system organ class and preferred terms
|
|
Eye disorders
Hordeolum
|
1.9%
1/53 • Number of events 1 • 3 months
Treatment-emergent adverse events using system organ class and preferred terms
|
0.00%
0/26 • 3 months
Treatment-emergent adverse events using system organ class and preferred terms
|
|
Eye disorders
Lacrimation decreased
|
1.9%
1/53 • Number of events 1 • 3 months
Treatment-emergent adverse events using system organ class and preferred terms
|
0.00%
0/26 • 3 months
Treatment-emergent adverse events using system organ class and preferred terms
|
|
Investigations
Vital dye staining cornea present
|
1.9%
1/53 • Number of events 1 • 3 months
Treatment-emergent adverse events using system organ class and preferred terms
|
0.00%
0/26 • 3 months
Treatment-emergent adverse events using system organ class and preferred terms
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Prior to publication or presentation, a copy of the final text should be forwarded by the Investigator(s) to the Sponsor or its designee, for comment. Such comments shall aim to ensure the scientific integrity of the proposed publications and/or presentations and ensure that the data and material referring to Sponsor products and activities receive fair, accurate, and reasonable presentation.
- Publication restrictions are in place
Restriction type: OTHER