Trial Outcomes & Findings for DD T2 Daily Disposable Registration Trial (NCT NCT03305770)
NCT ID: NCT03305770
Last Updated: 2019-02-22
Results Overview
VA was assessed for each eye individually using a Snellen chart at a distance of 4 meters. A 20/20 Snellen acuity is considered normal distance eyesight. No formal hypotheses were formulated; hence no inferential testing was performed.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
107 participants
Primary outcome timeframe
Dispense, Week 1, Week 2, Month 1, Month 2, Month 3
Results posted on
2019-02-22
Participant Flow
Subjects were recruited from 6 investigational sites located in the US.
This reporting group includes all randomized subjects (107).
Unit of analysis: Eyes
Participant milestones
| Measure |
DD T2
Verofilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses were inserted each day and discarded at the end of the day.
|
DT 1
Delefilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses were inserted each day and discarded at the end of the day.
|
|---|---|---|
|
Overall Study
STARTED
|
70 140
|
37 74
|
|
Overall Study
Enrolled Dispensed Analysis Set
|
70 140
|
36 72
|
|
Overall Study
Completed Analysis Set
|
69 138
|
36 72
|
|
Overall Study
COMPLETED
|
69 138
|
36 72
|
|
Overall Study
NOT COMPLETED
|
1 2
|
1 2
|
Reasons for withdrawal
| Measure |
DD T2
Verofilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses were inserted each day and discarded at the end of the day.
|
DT 1
Delefilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses were inserted each day and discarded at the end of the day.
|
|---|---|---|
|
Overall Study
Physician Decision - prior to dispense
|
0
|
1
|
|
Overall Study
Subject moved
|
1
|
0
|
Baseline Characteristics
DD T2 Daily Disposable Registration Trial
Baseline characteristics by cohort
| Measure |
DD T2
n=70 Participants
Verofilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses were inserted each day and discarded at the end of the day.
|
DT 1
n=37 Participants
Delefilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses will be inserted each day and discarded at the end of the day.
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.3 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
31.3 years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
33.3 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
65 participants
n=5 Participants
|
33 participants
n=7 Participants
|
98 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multi-racial
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Dispense, Week 1, Week 2, Month 1, Month 2, Month 3Population: Completed Analysis Set
VA was assessed for each eye individually using a Snellen chart at a distance of 4 meters. A 20/20 Snellen acuity is considered normal distance eyesight. No formal hypotheses were formulated; hence no inferential testing was performed.
Outcome measures
| Measure |
DD T2
n=138 eyes
Verofilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses were inserted each day and discarded at the end of the day.
|
DT 1
n=72 eyes
Delefilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses will be inserted each day and discarded at the end of the day.
|
|---|---|---|
|
Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)
Month 1 @ 20/20
|
72 eyes
|
40 eyes
|
|
Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)
Month 2 @ 20/15
|
63 eyes
|
33 eyes
|
|
Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)
Dispense @ 20/15
|
74 eyes
|
32 eyes
|
|
Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)
Dispense @ 20/20
|
62 eyes
|
40 eyes
|
|
Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)
Dispense @ 20/25
|
2 eyes
|
0 eyes
|
|
Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)
Dispense @ 20/30
|
0 eyes
|
0 eyes
|
|
Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)
Week 1 @ 20/15
|
75 eyes
|
36 eyes
|
|
Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)
Week 1 @ 20/20
|
58 eyes
|
36 eyes
|
|
Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)
Week 1 @ 20/25
|
4 eyes
|
0 eyes
|
|
Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)
Week 1 @ 20/30
|
1 eyes
|
0 eyes
|
|
Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)
Week 2 @ 20/15
|
69 eyes
|
35 eyes
|
|
Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)
Week 2 @ 20/20
|
65 eyes
|
37 eyes
|
|
Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)
Week 2 @ 20/25
|
4 eyes
|
0 eyes
|
|
Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)
Week 2 @ 20/30
|
0 eyes
|
0 eyes
|
|
Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)
Month 1 @ 20/15
|
62 eyes
|
31 eyes
|
|
Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)
Month 1 @ 20/25
|
4 eyes
|
1 eyes
|
|
Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)
Month 1 @ 20/30
|
0 eyes
|
0 eyes
|
|
Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)
Month 2 @ 20/20
|
68 eyes
|
36 eyes
|
|
Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)
Month 2 @ 20/25
|
7 eyes
|
3 eyes
|
|
Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)
Month 2 @ 20/30
|
0 eyes
|
0 eyes
|
|
Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)
Month 3 @ 20/15
|
63 eyes
|
35 eyes
|
|
Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)
Month 3 @ 20/20
|
69 eyes
|
37 eyes
|
|
Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)
Month 3 @ 20/25
|
6 eyes
|
0 eyes
|
|
Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)
Month 3 @ 20/30
|
0 eyes
|
0 eyes
|
Adverse Events
DD T2 Ocular
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DD T2 Non-ocular
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DT 1 Ocular
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DT 1 Non-ocular
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sr Director Project Leadership
Alcon, A Novartis Division
Phone: 1-888-451-3937
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER