Clinical Comparison of DDT2 Contact Lens and a Daily Disposable Contact Lens - Study 2
Study Details
Study Description
Brief Summary
The purpose of this study was to evaluate visual acuity at distance when wearing DDT2 contact lenses compared to Clariti contact lenses.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
Subjects were expected to attend 3 study visits and wear the DDT2 and Clariti study lenses in a crossover design for approximately 14 - 20 days (7 - 10 days for each product).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Other: DDT2, then Clariti Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality. |
Device: Verofilcon A contact lenses
Investigational daily disposable soft contact lenses
Other Names:
Device: Somofilcon A contact lenses
Commercially available daily disposable soft contact lenses
Other Names:
|
Other: Clariti, then DDT2 Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality. |
Device: Verofilcon A contact lenses
Investigational daily disposable soft contact lenses
Other Names:
Device: Somofilcon A contact lenses
Commercially available daily disposable soft contact lenses
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Least Squares Mean Distance Visual Acuity With Study Lenses [Day 8, each product]
Visual acuity was assessed and collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.
Eligibility Criteria
Criteria
Key Inclusion Criteria:
-
Able to understand and sign an Informed Consent Form that has been approved by an Institutional Review Board.
-
Willing and able to attend all scheduled study visits as required per protocol.
-
Current wearer of spherical soft contact lenses.
Key Exclusion Criteria:
-
Any ocular condition that contraindicates contact lens wear.
-
Previous or current habitual wearer of clariti® or DAILIES TOTAL1® contact lenses.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Alcon Investigative Site | Jacksonville | Florida | United States | 32256 |
2 | Alcon Investigative Site | Maitland | Florida | United States | 32751 |
3 | Alcon Investigative Site | Orlando | Florida | United States | 32803 |
4 | Alcon Investigative Site | Bloomington | Illinois | United States | 61701 |
5 | Alcon Investigative Site | Powell | Ohio | United States | 43065 |
6 | Alcon Investigative Site | Warwick | Rhode Island | United States | 02888 |
7 | Alcon Investigative Site | Brentwood | Tennessee | United States | 37027 |
8 | Alcon Investigative Site | Memphis | Tennessee | United States | 38111 |
Sponsors and Collaborators
- Alcon Research
Investigators
- Study Director: CDMA Project Lead, Vision Care, Alcon Research, LLC
Study Documents (Full-Text)
More Information
Publications
None provided.- CLE383-C010
Study Results
Participant Flow
Recruitment Details | This study was performed at 8 study centers in the United States (US). |
---|---|
Pre-assignment Detail | Of the 154 enrolled, 2 were exited from the study as screen failures and 1 subject was randomized but not exposed. This reporting group includes all exposed subjects (151). |
Arm/Group Title | DDT2, Then Clariti | Clariti, Then DDT2 |
---|---|---|
Arm/Group Description | Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality. | Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality. |
Period Title: First Wear Period (8 -1/+2 Days) | ||
STARTED | 76 | 75 |
COMPLETED | 76 | 75 |
NOT COMPLETED | 0 | 0 |
Period Title: First Wear Period (8 -1/+2 Days) | ||
STARTED | 74 | 75 |
COMPLETED | 73 | 74 |
NOT COMPLETED | 1 | 1 |
Baseline Characteristics
Arm/Group Title | DDT2, Then Clariti | Clariti, Then DDT2 | Total |
---|---|---|---|
Arm/Group Description | Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality. Verofilcon A contact lenses: Investigational daily disposable soft contact lenses Somofilcon A contact lenses: Commercially available daily disposable soft contact lenses | Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality. Verofilcon A contact lenses: Investigational daily disposable soft contact lenses Somofilcon A contact lenses: Commercially available daily disposable soft contact lenses | Total of all reporting groups |
Overall Participants | 76 | 75 | 151 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
35.1
(7.9)
|
31.8
(7.9)
|
33.5
(8.1)
|
Sex: Female, Male (Count of Participants) | |||
Female |
56
73.7%
|
47
62.7%
|
103
68.2%
|
Male |
20
26.3%
|
28
37.3%
|
48
31.8%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
3
3.9%
|
6
8%
|
9
6%
|
Not Hispanic or Latino |
73
96.1%
|
69
92%
|
142
94%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Race/Ethnicity, Customized (Count of Participants) | |||
White |
65
85.5%
|
67
89.3%
|
132
87.4%
|
Black or African American |
5
6.6%
|
1
1.3%
|
6
4%
|
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
Asian |
1
1.3%
|
0
0%
|
1
0.7%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
Other |
1
1.3%
|
2
2.7%
|
3
2%
|
Multi-racial |
1
1.3%
|
0
0%
|
1
0.7%
|
Region of Enrollment (participants) [Number] | |||
United States |
76
100%
|
75
100%
|
151
100%
|
Outcome Measures
Title | Least Squares Mean Distance Visual Acuity With Study Lenses |
---|---|
Description | Visual acuity was assessed and collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. |
Time Frame | Day 8, each product |
Outcome Measure Data
Analysis Population Description |
---|
Full analysis set (FAS): All randomized subjects/eyes with non-missing responses, who were exposed to any study lenses evaluated in this study, with the exception of the lenses used at Visit 1 for optimization and fitting. |
Arm/Group Title | DDT2 | Clariti |
---|---|---|
Arm/Group Description | Verofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -1/+2 days in a daily disposable modality. | Somofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -1/+2 days in a daily disposable modality. |
Measure Participants | 151 | 149 |
Measure eyes | 294 | 296 |
Least Squares Mean (Standard Error) [logMAR] |
-0.08
(0.006)
|
-0.08
(0.006)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | DDT2, Clariti |
---|---|---|
Comments | ||
Type of Statistical Test | Non-Inferiority | |
Comments | Non-inferiority margin = 0.05 | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 0.00 | |
Confidence Interval |
(1-Sided) 95% to 0.01 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Difference = DDT2 - Clariti |
Adverse Events
Time Frame | Adverse events were collected from time of consent to study exit (approximately 14-20 days). The safety analysis set included all subjects/eyes exposed to any study lenses evaluated in this study, with the exception of the lenses used at Visit 1 for the purpose of parameter optimization and fitting, as they were not intended for the assessment of safety. | |||||||
---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | Adverse events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population of ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. | |||||||
Arm/Group Title | DDT2 - Ocular | DDT2 - Systemic / Nonocular | Clariti - Ocular | Clariti - Systemic / Nonocular | ||||
Arm/Group Description | Verofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -1/+2 days in a daily disposable modality. | Verofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -1/+2 days in a daily disposable modality. | Somofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -1/+2 days in a daily disposable modality. | Somofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -1/+2 days in a daily disposable modality. | ||||
All Cause Mortality |
||||||||
DDT2 - Ocular | DDT2 - Systemic / Nonocular | Clariti - Ocular | Clariti - Systemic / Nonocular | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/302 (0%) | 0/151 (0%) | 0/298 (0%) | 0/149 (0%) | ||||
Serious Adverse Events |
||||||||
DDT2 - Ocular | DDT2 - Systemic / Nonocular | Clariti - Ocular | Clariti - Systemic / Nonocular | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/302 (0%) | 0/151 (0%) | 0/298 (0%) | 0/149 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
DDT2 - Ocular | DDT2 - Systemic / Nonocular | Clariti - Ocular | Clariti - Systemic / Nonocular | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/302 (0%) | 0/151 (0%) | 0/298 (0%) | 0/149 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Name/Title | CDMA Project Lead, Vision Care |
---|---|
Organization | Alcon Research, LLC |
Phone | 1-888-451-3937 |
alcon.medinfo@alcon.com |
- CLE383-C010