Trial Outcomes & Findings for A Prospective Study of Two Daily Disposable Contact Lenses (NCT NCT01636986)
NCT ID: NCT01636986
Last Updated: 2014-01-14
Results Overview
Contact lens symptoms were evaluated using the Contact Lens and Dry Eye Questionnaire (CLDEQ). The participant indicated the frequency with which 9 common contact lens-related ocular surface dryness symptoms were experienced over the previous week. Each symptom was rated on a 5-point scale (1=never, 5=constantly). Both eyes contributed to the mean. A more negative change number indicates a greater perceived improvement, namely, lessening of the symptom.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
Day 0, Week 4
Results posted on
2014-01-14
Participant Flow
Participants were recruited from 1 US study center.
This reporting group includes all enrolled and randomized participants.
Participant milestones
| Measure |
DAILIES TOTAL1
Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
|
1DAVM
Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
32
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
DAILIES TOTAL1
Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
|
1DAVM
Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Corneal Staining
|
0
|
1
|
Baseline Characteristics
A Prospective Study of Two Daily Disposable Contact Lenses
Baseline characteristics by cohort
| Measure |
DAILIES TOTAL1
n=30 Participants
Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
|
1DAVM
n=30 Participants
Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23.26 years
STANDARD_DEVIATION 4.28 • n=5 Participants
|
24.53 years
STANDARD_DEVIATION 4.83 • n=7 Participants
|
23.89 years
STANDARD_DEVIATION 4.56 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0, Week 4Population: All enrolled and randomized participants who completed the study.
Contact lens symptoms were evaluated using the Contact Lens and Dry Eye Questionnaire (CLDEQ). The participant indicated the frequency with which 9 common contact lens-related ocular surface dryness symptoms were experienced over the previous week. Each symptom was rated on a 5-point scale (1=never, 5=constantly). Both eyes contributed to the mean. A more negative change number indicates a greater perceived improvement, namely, lessening of the symptom.
Outcome measures
| Measure |
DAILIES TOTAL1
n=30 Participants
Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
|
1DAVM
n=30 Participants
Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
|
|---|---|---|
|
Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ
Eyes feel uncomfortable
|
-0.21 Units on a scale
Standard Deviation 0.13
|
-0.17 Units on a scale
Standard Deviation 0.16
|
|
Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ
Eyes feel dry
|
-1.07 Units on a scale
Standard Deviation 0.68
|
-0.92 Units on a scale
Standard Deviation 0.90
|
|
Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ
Vision change between clear and blurry
|
-0.04 Units on a scale
Standard Deviation 0.04
|
-0.04 Units on a scale
Standard Deviation 0.04
|
|
Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ
Eyes feel irritated
|
-0.42 Units on a scale
Standard Deviation 0.32
|
-0.31 Units on a scale
Standard Deviation 0.28
|
|
Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ
Eyes feel gritty and scratchy
|
-0.10 Units on a scale
Standard Deviation 0.10
|
-0.07 Units on a scale
Standard Deviation 0.07
|
|
Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ
Feel "something" in the eye
|
-0.47 Units on a scale
Standard Deviation 0.58
|
-0.38 Units on a scale
Standard Deviation 0.54
|
|
Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ
Eyes burning and stinging
|
-0.25 Units on a scale
Standard Deviation 0.34
|
-0.28 Units on a scale
Standard Deviation 0.36
|
|
Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ
Eyes feel unusually sensitive to bright light
|
-0.23 Units on a scale
Standard Deviation 0.35
|
-0.19 Units on a scale
Standard Deviation 0.32
|
|
Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ
Eyes itch
|
-0.43 Units on a scale
Standard Deviation 0.41
|
-0.38 Units on a scale
Standard Deviation 0.46
|
Adverse Events
DAILIES TOTAL1
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
1DAVM
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DAILIES TOTAL1
n=30 participants at risk
Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
|
1DAVM
n=32 participants at risk
Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
|
|---|---|---|
|
Eye disorders
Contact lens fell out
|
0.00%
0/30 • Adverse events were collected for the duration of the study (4 months).
This reporting group includes all enrolled participants who were exposed to the test product.
|
6.2%
2/32 • Adverse events were collected for the duration of the study (4 months).
This reporting group includes all enrolled participants who were exposed to the test product.
|
|
Eye disorders
Eye irritation
|
13.3%
4/30 • Adverse events were collected for the duration of the study (4 months).
This reporting group includes all enrolled participants who were exposed to the test product.
|
12.5%
4/32 • Adverse events were collected for the duration of the study (4 months).
This reporting group includes all enrolled participants who were exposed to the test product.
|
|
Eye disorders
Corneal Staining
|
3.3%
1/30 • Adverse events were collected for the duration of the study (4 months).
This reporting group includes all enrolled participants who were exposed to the test product.
|
6.2%
2/32 • Adverse events were collected for the duration of the study (4 months).
This reporting group includes all enrolled participants who were exposed to the test product.
|
|
Eye disorders
Foreign body sensation
|
6.7%
2/30 • Adverse events were collected for the duration of the study (4 months).
This reporting group includes all enrolled participants who were exposed to the test product.
|
0.00%
0/32 • Adverse events were collected for the duration of the study (4 months).
This reporting group includes all enrolled participants who were exposed to the test product.
|
Additional Information
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