Trial Outcomes & Findings for Initial Performance of a Daily Disposable Contact Lens Featuring Molded Marks (NCT NCT02939170)
NCT ID: NCT02939170
Last Updated: 2018-07-02
Results Overview
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device (test article). Ocular discomfort device-related AE was defined as an ocular AE classified as "Related" to study device and deemed to be related to ocular discomfort.
COMPLETED
NA
87 participants
Day 1 at Hour 9
2018-07-02
Participant Flow
Subjects were recruited from 5 study centers located in the United States.
Of the 87 enrolled, 7 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (80).
Participant milestones
| Measure |
DT1 MF MM
Delefilcon A multifocal contact lenses with molded marks on back surface worn bilaterally (in both eyes) for 9 hours
|
DT1 MF
Delefilcon A multifocal contact lenses worn bilaterally for 9 hours
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Initial Performance of a Daily Disposable Contact Lens Featuring Molded Marks
Baseline characteristics by cohort
| Measure |
DT1 MF MM
n=40 Participants
Delefilcon A multifocal contact lenses with molded marks on back surface worn bilaterally for 9 hours
|
DT1 MF
n=40 Participants
Delefilcon A multifocal contact lenses worn bilaterally for 9 hours
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.2 years
STANDARD_DEVIATION 9.47 • n=99 Participants
|
36.1 years
STANDARD_DEVIATION 10.07 • n=107 Participants
|
36.2 years
STANDARD_DEVIATION 9.71 • n=206 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1 at Hour 9Population: Safety Analysis Set
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device (test article). Ocular discomfort device-related AE was defined as an ocular AE classified as "Related" to study device and deemed to be related to ocular discomfort.
Outcome measures
| Measure |
DT1 MF MM
n=80 Eyes
Delefilcon A multifocal contact lenses with molded marks on back surface worn bilaterally for 9 hours
|
DT1 MF
n=80 Eyes
Delefilcon A multifocal contact lenses worn bilaterally for 9 hours
|
|---|---|---|
|
Incidence of Ocular Discomfort Device-related Adverse Events (AE)
|
0 Events
|
1 Events
|
SECONDARY outcome
Timeframe: Day 1 at Hour 9Population: Safety Analysis Set
Assessed by the Investigator through slit-lamp examination and graded on a 5-point scale, where 0=none and 4=severe. Ocular staining was categorized by corneal staining, conjunctival staining, and limbal staining. Both eyes contributed to the analysis.
Outcome measures
| Measure |
DT1 MF MM
n=80 Eyes
Delefilcon A multifocal contact lenses with molded marks on back surface worn bilaterally for 9 hours
|
DT1 MF
n=80 Eyes
Delefilcon A multifocal contact lenses worn bilaterally for 9 hours
|
|---|---|---|
|
Ocular Staining
Corneal Staining, Grade 0
|
62 Eyes
|
63 Eyes
|
|
Ocular Staining
Corneal Staining, Grade 1
|
14 Eyes
|
17 Eyes
|
|
Ocular Staining
Corneal Staining, Grade 2
|
4 Eyes
|
0 Eyes
|
|
Ocular Staining
Corneal Staining, Grade 3
|
0 Eyes
|
0 Eyes
|
|
Ocular Staining
Corneal Staining, Grade 4
|
0 Eyes
|
0 Eyes
|
|
Ocular Staining
Conjunctival Staining, Grade 0
|
60 Eyes
|
61 Eyes
|
|
Ocular Staining
Conjunctival Staining, Grade 1
|
15 Eyes
|
15 Eyes
|
|
Ocular Staining
Conjunctival Staining, Grade 2
|
5 Eyes
|
4 Eyes
|
|
Ocular Staining
Conjunctival Staining, Grade 3
|
0 Eyes
|
0 Eyes
|
|
Ocular Staining
Conjunctival Staining, Grade 4
|
0 Eyes
|
0 Eyes
|
|
Ocular Staining
Limbal Staining, Grade 0
|
72 Eyes
|
67 Eyes
|
|
Ocular Staining
Limbal Staining, Grade 1
|
7 Eyes
|
13 Eyes
|
|
Ocular Staining
Limbal Staining, Grade 2
|
1 Eyes
|
0 Eyes
|
|
Ocular Staining
Limbal Staining, Grade 3
|
0 Eyes
|
0 Eyes
|
|
Ocular Staining
Limbal Staining, Grade 4
|
0 Eyes
|
0 Eyes
|
SECONDARY outcome
Timeframe: Day 1 at Hour 9Population: Safety Analysis Set
Hyperemia (excess of blood) was assessed by the Investigator through slit-lamp examination and graded on a 5-point scale, where 0=none and 4=severe. Both eyes contributed to the analysis.
Outcome measures
| Measure |
DT1 MF MM
n=80 Eyes
Delefilcon A multifocal contact lenses with molded marks on back surface worn bilaterally for 9 hours
|
DT1 MF
n=80 Eyes
Delefilcon A multifocal contact lenses worn bilaterally for 9 hours
|
|---|---|---|
|
Limbal Hyperemia
Grade 2
|
0 Eyes
|
1 Eyes
|
|
Limbal Hyperemia
Grade 3
|
0 Eyes
|
0 Eyes
|
|
Limbal Hyperemia
Grade 4
|
0 Eyes
|
0 Eyes
|
|
Limbal Hyperemia
Grade 0
|
60 Eyes
|
52 Eyes
|
|
Limbal Hyperemia
Grade 1
|
20 Eyes
|
27 Eyes
|
Adverse Events
Pre-treatment
DT1 MF MM
DT1 MF
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Clinical Project Lead, Clinical Affairs
Alcon, A Novartis Division
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