Trial Outcomes & Findings for Evaluation of the Safety and Efficacy of PEGAVISION Silicone Hydrogel Daily Disposable Soft Contact Lenses (G3) (NCT NCT06995781)
NCT ID: NCT06995781
Last Updated: 2026-08-20
Results Overview
Distance visual acuity (VA), corrected by contact lenses in both eyes, will be measured using the LogMAR chart. The mean LogMAR score at each time point (Day 1, 1 week, 1 month, 2 months, and 3 months) will be used to assess visual performance over time. Unit of Measure: LogMAR (logarithm of the minimum angle of resolution)
Recruitment status
COMPLETED
Target enrollment
69 participants
Primary outcome timeframe
Day 1, 1 week (±2 days), 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days)
Results posted on
2026-08-20
Participant Flow
The study enrolled and randomly assigned 69 subjects, including a 15% dropout rate. The study was conducted at 5 investigational sites with ≤ 25% differences in enrollment numbers between sites. Upon registration at each study site, subjects sequentially assigned a random identification number and allocated to either the test or control groups in a 2:1 ratio.
Lens distribution complied with a pre-established randomization protocol, which was communicated to authorized personnel at each research site. To mitigate bias, the study was conducted under double-blind conditions. Prior to the initiation of contact lens wear, subjects received comprehensive instructions on the contact lens fitting process.
Unit of analysis: eyes
Participant milestones
| Measure |
Experimental Arm
The arms in this clinical trial are classified as:
Experimental Arm - Participants receive the PEGAVISION G3 Silicone Hydrogel Daily Disposable Soft Contact Lenses (Test Group).
|
Active Comparator Arm
Participants receive the CooperVision Clariti 1 day Soft Contact Lenses (Control Group).
|
|---|---|---|
|
Overall Study
STARTED
|
46 92
|
23 46
|
|
Overall Study
COMPLETED
|
46 92
|
23 46
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Each eye was assessed separately.
Baseline characteristics by cohort
| Measure |
Experimental Arm
n=92 eyes
The arms in this clinical trial are classified as:
Experimental Arm - Participants receive the PEGAVISION G3 Silicone Hydrogel Daily Disposable Soft Contact Lenses (Test Group).
|
Active Comparator Arm
n=46 eyes
Participants receive the CooperVision Clariti 1 day Soft Contact Lenses (Control Group).
|
Total
n=138 eyes
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.43 years
STANDARD_DEVIATION 7.503 • n=5 Participants
|
32.43 years
STANDARD_DEVIATION 8.738 • n=109 Participants
|
31.10 years
STANDARD_DEVIATION 7.928 • n=133 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
12 Participants
n=109 Participants
|
47 Participants
n=133 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
11 Participants
n=109 Participants
|
22 Participants
n=133 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
3 Participants
n=109 Participants
|
13 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
16 Participants
n=109 Participants
|
49 Participants
n=133 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
4 Participants
n=109 Participants
|
7 Participants
n=133 Participants
|
|
Tear Breakup Time Test test
Right eye(OD）
|
8.66 seconds
STANDARD_DEVIATION 1.805 • n=5 Participants • Each eye was assessed separately.
|
8.95 seconds
STANDARD_DEVIATION 1.750 • n=109 Participants • Each eye was assessed separately.
|
8.76 seconds
STANDARD_DEVIATION 1.779 • n=133 Participants • Each eye was assessed separately.
|
|
Tear Breakup Time Test test
Left eye(OS)
|
8.60 seconds
STANDARD_DEVIATION 1.848 • n=5 Participants • Each eye was assessed separately.
|
8.61 seconds
STANDARD_DEVIATION 1.842 • n=109 Participants • Each eye was assessed separately.
|
8.60 seconds
STANDARD_DEVIATION 1.833 • n=133 Participants • Each eye was assessed separately.
|
PRIMARY outcome
Timeframe: Day 1, 1 week (±2 days), 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days)Distance visual acuity (VA), corrected by contact lenses in both eyes, will be measured using the LogMAR chart. The mean LogMAR score at each time point (Day 1, 1 week, 1 month, 2 months, and 3 months) will be used to assess visual performance over time. Unit of Measure: LogMAR (logarithm of the minimum angle of resolution)
Outcome measures
| Measure |
Experimental Arm
n=92 eyes
The arms in this clinical trial are classified as:
Experimental Arm - Participants receive the PEGAVISION G3 Silicone Hydrogel Daily Disposable Soft Contact Lenses (Test Group).
|
Active Comparator Arm
n=46 eyes
Participants receive the CooperVision Clariti 1 day Soft Contact Lenses (Control Group).
|
|---|---|---|
|
Change in Distance Visual Acuity (VA) Corrected by Contact Lenses
Baseline
|
-0.08 logMAR
Standard Deviation 0.061
|
-0.08 logMAR
Standard Deviation 0.050
|
|
Change in Distance Visual Acuity (VA) Corrected by Contact Lenses
1-week
|
-0.08 logMAR
Standard Deviation 0.059
|
-0.09 logMAR
Standard Deviation 0.059
|
|
Change in Distance Visual Acuity (VA) Corrected by Contact Lenses
1-month
|
-0.09 logMAR
Standard Deviation 0.065
|
-0.08 logMAR
Standard Deviation 0.057
|
|
Change in Distance Visual Acuity (VA) Corrected by Contact Lenses
2-month
|
-0.09 logMAR
Standard Deviation 0.070
|
-0.10 logMAR
Standard Deviation 0.066
|
|
Change in Distance Visual Acuity (VA) Corrected by Contact Lenses
3-month
|
-0.10 logMAR
Standard Deviation 0.059
|
-0.12 logMAR
Standard Deviation 0.075
|
|
Change in Distance Visual Acuity (VA) Corrected by Contact Lenses
Average VA across all visits
|
-0.09 logMAR
Standard Deviation 0.057
|
-0.10 logMAR
Standard Deviation 0.057
|
SECONDARY outcome
Timeframe: up to 12 weeksIncidence of corneal abnormalities, including corneal edema, epithelial microcysts, corneal staining, limbal/bulbar injection, conjunctival abnormalities, and corneal neovascularization/infiltrates, as assessed using slit-lamp examination and graded with the Efron Grading Scale. Outcome is longitudinal tracking of the same measure (not multiple distinct outcomes
Outcome measures
| Measure |
Experimental Arm
n=92 eyes
The arms in this clinical trial are classified as:
Experimental Arm - Participants receive the PEGAVISION G3 Silicone Hydrogel Daily Disposable Soft Contact Lenses (Test Group).
|
Active Comparator Arm
n=46 eyes
Participants receive the CooperVision Clariti 1 day Soft Contact Lenses (Control Group).
|
|---|---|---|
|
Incidence of Corneal Abnormalities Above Grade 2 on the Efron Grading Scale
Baseline · Yes
|
0 eyes
|
0 eyes
|
|
Incidence of Corneal Abnormalities Above Grade 2 on the Efron Grading Scale
Baseline · No
|
92 eyes
|
46 eyes
|
|
Incidence of Corneal Abnormalities Above Grade 2 on the Efron Grading Scale
1-week · Yes
|
0 eyes
|
0 eyes
|
|
Incidence of Corneal Abnormalities Above Grade 2 on the Efron Grading Scale
1-week · No
|
92 eyes
|
46 eyes
|
|
Incidence of Corneal Abnormalities Above Grade 2 on the Efron Grading Scale
1-month · Yes
|
0 eyes
|
0 eyes
|
|
Incidence of Corneal Abnormalities Above Grade 2 on the Efron Grading Scale
1-month · No
|
92 eyes
|
46 eyes
|
|
Incidence of Corneal Abnormalities Above Grade 2 on the Efron Grading Scale
2-month · Yes
|
0 eyes
|
0 eyes
|
|
Incidence of Corneal Abnormalities Above Grade 2 on the Efron Grading Scale
2-month · No
|
92 eyes
|
46 eyes
|
|
Incidence of Corneal Abnormalities Above Grade 2 on the Efron Grading Scale
3-month · Yes
|
0 eyes
|
0 eyes
|
|
Incidence of Corneal Abnormalities Above Grade 2 on the Efron Grading Scale
3-month · No
|
92 eyes
|
46 eyes
|
SECONDARY outcome
Timeframe: up to 12 weeksPopulation: Data for each eye are reported separately.
Lens Fit and Surface Condition Measure: Lens centration, movement, and deposits assessed via slit-lamp biomicroscopy. Time Frame: Assessed at all study visits. Purpose: To compare the on-eye performance and stability of PEGAVISION G3 lenses with control lenses.
Outcome measures
| Measure |
Experimental Arm
n=92 eyes
The arms in this clinical trial are classified as:
Experimental Arm - Participants receive the PEGAVISION G3 Silicone Hydrogel Daily Disposable Soft Contact Lenses (Test Group).
|
Active Comparator Arm
n=46 eyes
Participants receive the CooperVision Clariti 1 day Soft Contact Lenses (Control Group).
|
|---|---|---|
|
Lens Fit and Surface Condition (Coverage)
OD_Day 1 · Complete
|
46 eyes
|
23 eyes
|
|
Lens Fit and Surface Condition (Coverage)
OD_Day 1 · partial
|
0 eyes
|
0 eyes
|
|
Lens Fit and Surface Condition (Coverage)
OD_1-week · Complete
|
46 eyes
|
23 eyes
|
|
Lens Fit and Surface Condition (Coverage)
OD_1-week · partial
|
0 eyes
|
0 eyes
|
|
Lens Fit and Surface Condition (Coverage)
OD_1-month · Complete
|
46 eyes
|
23 eyes
|
|
Lens Fit and Surface Condition (Coverage)
OD_1-month · partial
|
0 eyes
|
0 eyes
|
|
Lens Fit and Surface Condition (Coverage)
OD_2-month · Complete
|
46 eyes
|
23 eyes
|
|
Lens Fit and Surface Condition (Coverage)
OD_2-month · partial
|
0 eyes
|
0 eyes
|
|
Lens Fit and Surface Condition (Coverage)
OD_3-month · Complete
|
46 eyes
|
23 eyes
|
|
Lens Fit and Surface Condition (Coverage)
OD_3-month · partial
|
0 eyes
|
0 eyes
|
|
Lens Fit and Surface Condition (Coverage)
OS_Day1 · Complete
|
46 eyes
|
23 eyes
|
|
Lens Fit and Surface Condition (Coverage)
OS_Day1 · partial
|
0 eyes
|
0 eyes
|
|
Lens Fit and Surface Condition (Coverage)
OS_1-week · Complete
|
46 eyes
|
23 eyes
|
|
Lens Fit and Surface Condition (Coverage)
OS_1-week · partial
|
0 eyes
|
0 eyes
|
|
Lens Fit and Surface Condition (Coverage)
OS_1-month · Complete
|
46 eyes
|
23 eyes
|
|
Lens Fit and Surface Condition (Coverage)
OS_1-month · partial
|
0 eyes
|
0 eyes
|
|
Lens Fit and Surface Condition (Coverage)
OS_2-month · Complete
|
46 eyes
|
23 eyes
|
|
Lens Fit and Surface Condition (Coverage)
OS_2-month · partial
|
0 eyes
|
0 eyes
|
|
Lens Fit and Surface Condition (Coverage)
OS_3-month · Complete
|
46 eyes
|
23 eyes
|
|
Lens Fit and Surface Condition (Coverage)
OS_3-month · partial
|
0 eyes
|
0 eyes
|
SECONDARY outcome
Timeframe: up to 12 weeksAdverse Events Monitoring Measure: Number and type of adverse events related to contact lens use. Time Frame: Throughout the entire study duration. Purpose: To monitor potential complications and evaluate the safety profile of PEGAVISION G3 lenses.
Outcome measures
| Measure |
Experimental Arm
n=46 Participants
The arms in this clinical trial are classified as:
Experimental Arm - Participants receive the PEGAVISION G3 Silicone Hydrogel Daily Disposable Soft Contact Lenses (Test Group).
|
Active Comparator Arm
n=23 Participants
Participants receive the CooperVision Clariti 1 day Soft Contact Lenses (Control Group).
|
|---|---|---|
|
Adverse Events Monitoring
Subjects with SAE
|
0 Participants
|
0 Participants
|
|
Adverse Events Monitoring
Subjects with ocular non-significant AE
|
2 Participants
|
1 Participants
|
|
Adverse Events Monitoring
Subjects with mild AE
|
2 Participants
|
1 Participants
|
|
Adverse Events Monitoring
Subject with moderate AE
|
0 Participants
|
0 Participants
|
|
Adverse Events Monitoring
Subjects with severe AE
|
0 Participants
|
0 Participants
|
|
Adverse Events Monitoring
Subjects with ADE
|
1 Participants
|
1 Participants
|
|
Adverse Events Monitoring
Subjects with significant AE
|
0 Participants
|
0 Participants
|
|
Adverse Events Monitoring
Subjects with SADE
|
0 Participants
|
0 Participants
|
|
Adverse Events Monitoring
Subjects with OSAE
|
0 Participants
|
0 Participants
|
|
Adverse Events Monitoring
Subjects with ocular significant AE
|
0 Participants
|
0 Participants
|
|
Adverse Events Monitoring
Subjects temporarily discontinued due to AE
|
1 Participants
|
1 Participants
|
|
Adverse Events Monitoring
Subjects permanently discontinued due to AE
|
0 Participants
|
0 Participants
|
|
Adverse Events Monitoring
Subjects' death due to AE
|
0 Participants
|
0 Participants
|
Adverse Events
Experimental Arm
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Active Comparator Arm
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 |
Experimental Arm
n=46 participants at risk
The arms in this clinical trial are classified as:
Experimental Arm - Participants receive the PEGAVISION G3 Silicone Hydrogel Daily Disposable Soft Contact Lenses (Test Group).
|
Active Comparator Arm
n=23 participants at risk
Participants receive the CooperVision Clariti 1 day Soft Contact Lenses (Control Group).
|
|---|---|---|
|
Eye disorders
mild
|
4.3%
2/46 • Number of events 2 • from enrollment until end of follow-up, up to 3-month
Adverse events were monitored throughout the study period. No adverse events were observed.
|
4.3%
1/23 • Number of events 1 • from enrollment until end of follow-up, up to 3-month
Adverse events were monitored throughout the study period. No adverse events were observed.
|
|
Eye disorders
moderate
|
0.00%
0/46 • from enrollment until end of follow-up, up to 3-month
Adverse events were monitored throughout the study period. No adverse events were observed.
|
0.00%
0/23 • from enrollment until end of follow-up, up to 3-month
Adverse events were monitored throughout the study period. No adverse events were observed.
|
|
Eye disorders
ADE
|
2.2%
1/46 • Number of events 1 • from enrollment until end of follow-up, up to 3-month
Adverse events were monitored throughout the study period. No adverse events were observed.
|
4.3%
1/23 • Number of events 1 • from enrollment until end of follow-up, up to 3-month
Adverse events were monitored throughout the study period. No adverse events were observed.
|
|
Eye disorders
ocular non-significant AE
|
4.3%
2/46 • Number of events 2 • from enrollment until end of follow-up, up to 3-month
Adverse events were monitored throughout the study period. No adverse events were observed.
|
4.3%
1/23 • Number of events 1 • from enrollment until end of follow-up, up to 3-month
Adverse events were monitored throughout the study period. No adverse events were observed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place