Trial Outcomes & Findings for A Comparison of Two Contact Lenses (NCT NCT00700752)
NCT ID: NCT00700752
Last Updated: 2015-05-21
Results Overview
Subjective rating of overall comfort using a 0 through 5 scale. 0=n/a, 1=poor, 2=fair, 3=good, 4=very good, 5=excellent. Scores from 2-week and 4-week visits were combined for final values.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
after 4 weeks of lens wear
Results posted on
2015-05-21
Participant Flow
Participant milestones
| Measure |
Senofilcon A/Balafilcon A
senofilcon A silicone hydrogel contact lens worn first, balafilcon A silicone hydrogel contact lens worn second.
|
Balafilcon A/Senofilcon A
balafilcon A silicone hydrogel contact lens worn first, senofilcon A silicone hydrogel contact lens worn second.
|
|---|---|---|
|
First Intervention
STARTED
|
20
|
20
|
|
First Intervention
COMPLETED
|
20
|
18
|
|
First Intervention
NOT COMPLETED
|
0
|
2
|
|
Second Intervention
STARTED
|
20
|
18
|
|
Second Intervention
COMPLETED
|
20
|
18
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Senofilcon A/Balafilcon A
senofilcon A silicone hydrogel contact lens worn first, balafilcon A silicone hydrogel contact lens worn second.
|
Balafilcon A/Senofilcon A
balafilcon A silicone hydrogel contact lens worn first, senofilcon A silicone hydrogel contact lens worn second.
|
|---|---|---|
|
First Intervention
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
A Comparison of Two Contact Lenses
Baseline characteristics by cohort
| Measure |
Overall
n=38 Participants
Completed study population
|
|---|---|
|
Age, Continuous
|
24.4 years
STANDARD_DEVIATION 3.4 • n=39 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: after 4 weeks of lens wearSubjective rating of overall comfort using a 0 through 5 scale. 0=n/a, 1=poor, 2=fair, 3=good, 4=very good, 5=excellent. Scores from 2-week and 4-week visits were combined for final values.
Outcome measures
| Measure |
Senofilcon A
n=38 Participants
silicone hydrogel contact lens worn daily with a 2-week replacement regimen.
|
Balafilcon A
n=38 Participants
silicone hydrogel contact lens worn daily with a 4-week replacement regimen
|
|---|---|---|
|
Patient-reported Comfort at at the Manufacturer's Recommended Lens Replacement Timeframe of 2-weeks (Senofilcon A) or 4-weeks (Balafilcon A).
|
4.0074 Units on a scale
Standard Error 0.2008
|
2.8438 Units on a scale
Standard Error 0.1972
|
Adverse Events
Senofilcon A/Balafilcon A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Balafilcon A/Senofilcon A
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
Kurt Moody OD
Vistakon
Phone: 904-443-3088
Results disclosure agreements
- Principal investigator is a sponsor employee The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.
- Publication restrictions are in place
Restriction type: OTHER