Trial Outcomes & Findings for Comparison of Three Soft Bifocal Contact Lenses (NCT NCT00808340)
NCT ID: NCT00808340
Last Updated: 2018-06-19
Results Overview
Tested with both eyes together in bright lighting, reading charts distant to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
COMPLETED
NA
37 participants
5 minutes after insertion
2018-06-19
Participant Flow
Participant milestones
| Measure |
Senofilcon A Test/Senofilcon A Prod/Balafilcon A
Subjects wear 3 multifocal contact lenses: senofilcon A test worn first, senofilcon A production worn second, and balafilcon A worn third.
|
Senofilcon A Test/Balafilcon A/Senofilcon A Prod
Subjects wear 3 multifocal contact lenses: senofilcon A test worn first, balafilcon A worn second, and senofilcon A production worn third.
|
Senofilcon A Prod/Senofilcon A Test/Balafilcon A
Subjects wear 3 multifocal contact lenses: senofilcon A prod worn first, senofilcon A test worn second, and balafilcon A worn third.
|
Senofilcon A Prod/ Balifilcon A/ Senofilcon A Test
Subjects wear 3 multifocal contact lenses: senofilcon A prod worn first, balafilcon A worn second, and senofilcon A test worn third.
|
Balafilcon A/Senofilcon A Test/Senofilcon A Prod
Subjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A test worn second, and senofilcon A production worn third.
|
Balafilcon A/Senofilcon A Prod/Senofilcon A Test
Subjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A producton worn second, senofilcon A test worn third.
|
|---|---|---|---|---|---|---|
|
First Intervention
STARTED
|
4
|
9
|
7
|
3
|
5
|
6
|
|
First Intervention
COMPLETED
|
4
|
9
|
7
|
3
|
5
|
6
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention
STARTED
|
4
|
9
|
7
|
3
|
5
|
6
|
|
Second Intervention
COMPLETED
|
4
|
9
|
7
|
3
|
5
|
6
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Intervention
STARTED
|
4
|
9
|
7
|
3
|
5
|
6
|
|
Third Intervention
COMPLETED
|
4
|
9
|
7
|
3
|
5
|
6
|
|
Third Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Three Soft Bifocal Contact Lenses
Baseline characteristics by cohort
| Measure |
Overall
n=34 Participants
|
|---|---|
|
Age, Continuous
|
50.5 years
STANDARD_DEVIATION 6.3 • n=99 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 5 minutes after insertionTested with both eyes together in bright lighting, reading charts distant to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
Outcome measures
| Measure |
Senofilcon A Test
n=34 Participants
senofilcon A test represents subjects that wore this lens in either the first, second, or third period.
|
Senofilcon A Prod
n=34 Participants
senofilcon A prod represents subjects that wore this lens in either the first, second, or third period.
|
Balafilcon A
n=34 Participants
balafilcon A represents subjects that wore this lens in either the first, second, or third period.
|
|---|---|---|---|
|
Distance Bright Illumination Binocular Visual Performance Reported as Visual Acuity
|
0.8191 logMAR
Standard Error 0.161
|
0.6942 logMAR
Standard Error 0.161
|
1.0635 logMAR
Standard Error 0.161
|
PRIMARY outcome
Timeframe: 5 minutes after insertionTested with both eyes together in bright lighting reading charts near to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
Outcome measures
| Measure |
Senofilcon A Test
n=34 Participants
senofilcon A test represents subjects that wore this lens in either the first, second, or third period.
|
Senofilcon A Prod
n=34 Participants
senofilcon A prod represents subjects that wore this lens in either the first, second, or third period.
|
Balafilcon A
n=34 Participants
balafilcon A represents subjects that wore this lens in either the first, second, or third period.
|
|---|---|---|---|
|
Near Bright Illumination Binocular Visual Performance Reported as Visual Acuity
|
-0.6735 logMAR
Standard Error 0.161
|
-0.6327 logMAR
Standard Error 0.161
|
-0.1719 logMAR
Standard Error 0.161
|
PRIMARY outcome
Timeframe: after 1 week of lens wear, for each lens typeInvestigator rated type of corneal staining as either 0=none, 1=micropunctate, 2=macropunctate, 3=coalesced, or 4=patch(\> or = to mm).
Outcome measures
| Measure |
Senofilcon A Test
n=34 Participants
senofilcon A test represents subjects that wore this lens in either the first, second, or third period.
|
Senofilcon A Prod
n=34 Participants
senofilcon A prod represents subjects that wore this lens in either the first, second, or third period.
|
Balafilcon A
n=34 Participants
balafilcon A represents subjects that wore this lens in either the first, second, or third period.
|
|---|---|---|---|
|
Type of Corneal Staining
|
0.1311 Units on a scale
Standard Error 0.07154
|
0.1017 Units on a scale
Standard Error 0.07154
|
0.1694 Units on a scale
Standard Error 0.07154
|
PRIMARY outcome
Timeframe: after 1 week of lens wear, for each lens typeSubject rated the overall quality of vision with the study contact lenses. 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
Outcome measures
| Measure |
Senofilcon A Test
n=34 Participants
senofilcon A test represents subjects that wore this lens in either the first, second, or third period.
|
Senofilcon A Prod
n=34 Participants
senofilcon A prod represents subjects that wore this lens in either the first, second, or third period.
|
Balafilcon A
n=34 Participants
balafilcon A represents subjects that wore this lens in either the first, second, or third period.
|
|---|---|---|---|
|
Overall Subjective Vision
|
3.5373 Units on a scale
Standard Error 0.1681
|
3.207 Units on a scale
Standard Error 0.1681
|
3.4351 Units on a scale
Standard Error 0.1681
|
Adverse Events
Senofilcon A Test
Senofilcon A Prod
Balafilcon A
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Tom Karkkainen, OD
Vistakon
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