Trial Outcomes & Findings for Evaluation of Two Toric Soft Contact Lenses After Two Weeks of Wear (NCT NCT00584220)
NCT ID: NCT00584220
Last Updated: 2015-05-21
Results Overview
A weighted combined score of one week and two week data calculated from individual vision-related questions asked on a 1-5 scale, 1 = most negative response to 5 = most positive, was used to derive vision outcomes. The analysis shows the outcome for both senofilcon A and alphafilcon A. If score \>0 then greater vision, if \<0 then lesser vision.
COMPLETED
NA
96 participants
1 week
2015-05-21
Participant Flow
Of those 96 enrolled subjects in the study, 7 did not meet the study eligibility criteria and 1 did not receive the study lenses. One enrolled subject was discontinued from the study leaving n=87 who completed the study.
Participant milestones
| Measure |
Senofilcon A / Alphafilcon A
senofilcon A toric silicone hydrogel contact lenses worn first, then alphafilcon A toric hydrogel contact lenses worn second
|
Alphafilcon A / Senofilcon A
alphafilcon A toric hydrogel contact lenses worn first, then senofilcon A toric silicone hydrogel contact lenses worn second
|
|---|---|---|
|
First Period
STARTED
|
48
|
39
|
|
First Period
COMPLETED
|
48
|
39
|
|
First Period
NOT COMPLETED
|
0
|
0
|
|
Second Period
STARTED
|
48
|
39
|
|
Second Period
COMPLETED
|
48
|
39
|
|
Second Period
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Two Toric Soft Contact Lenses After Two Weeks of Wear
Baseline characteristics by cohort
| Measure |
All Subjects
n=87 Participants
Subjects who enrolled and completed the study.
|
|---|---|
|
Age, Continuous
|
28.0 years
STANDARD_DEVIATION 5.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 weekPopulation: Analysis includes only participants who completed the study per protocol and had no missing data.
A weighted combined score of one week and two week data calculated from individual vision-related questions asked on a 1-5 scale, 1 = most negative response to 5 = most positive, was used to derive vision outcomes. The analysis shows the outcome for both senofilcon A and alphafilcon A. If score \>0 then greater vision, if \<0 then lesser vision.
Outcome measures
| Measure |
Senofilcon A Toric
n=87 Participants
contact lenses
|
Alphafilcon A Toric
n=87 Participants
contact lenses
|
|---|---|---|
|
Subjective Reported Vision
|
0.33 Units on a scale
Standard Deviation 0.795
|
-0.17 Units on a scale
Standard Deviation 0.788
|
PRIMARY outcome
Timeframe: 1 weekPopulation: Analysis includes only participants who completed the study per protocol and had no missing data.
A weighted combined score of one week and two week data calculated from individual comfort-related questions asked on a 1-5 scale, 1=most negative response to 5=most positive response, was used to derive comfort outcomes. The analysis shows the estimates for senofilcon A and alphafilcon A, respectively. Interpretation is \>0 indicates comfortable and \<0 indicates uncomfortable.
Outcome measures
| Measure |
Senofilcon A Toric
n=87 Participants
contact lenses
|
Alphafilcon A Toric
n=87 Participants
contact lenses
|
|---|---|---|
|
Subject Reported Lens Comfort.
|
0.37 Units on a scale
Standard Deviation 0.730
|
-0.38 Units on a scale
Standard Deviation 0.723
|
Adverse Events
Senofilcon A
Alphafilcon A
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
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