Trial Outcomes & Findings for Comparison of Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period (NCT NCT00762502)
NCT ID: NCT00762502
Last Updated: 2018-06-19
Results Overview
Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
COMPLETED
NA
112 participants
at 3 months of lens wear (period 1)
2018-06-19
Participant Flow
Recruitment occurred at 1 site in the USA (n=50 enrolled), and 7 sites in Australia (n=62 enrolled)
Total of 112 subjects enrolled, 77 subjects completed study after 3 months. The study was then restricted down to two sites (Australia only) after 3 months with only 37 of the 77 being included. There were 36 subjects whom completed the full 6 month trial period.
Participant milestones
| Measure |
Senofilcon A Bilaterally
Senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. For those subject who continued the study from 3 months to 6 months, the same treatment was repeated.
|
Balafilcon A Bilaterally
Balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. For those subject who continued the study from 3 months to 6 months, the same treatment was repeated.
|
Senofilcon A Toric/Balafilcon A Toric Contralaterally
Senofilcon A toric lens worn in one eye and Balafilcon A toric lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly. For those subject who continued the study from 3 months to 6 months, the same treatment was repeated.
|
|---|---|---|---|
|
Baseline to Month 3 (Period 1)
STARTED
|
36
|
25
|
51
|
|
Baseline to Month 3 (Period 1)
COMPLETED
|
26
|
19
|
32
|
|
Baseline to Month 3 (Period 1)
NOT COMPLETED
|
10
|
6
|
19
|
|
Month 3 to Month 6 (Period 2)
STARTED
|
9
|
5
|
23
|
|
Month 3 to Month 6 (Period 2)
COMPLETED
|
9
|
4
|
23
|
|
Month 3 to Month 6 (Period 2)
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Senofilcon A Bilaterally
Senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. For those subject who continued the study from 3 months to 6 months, the same treatment was repeated.
|
Balafilcon A Bilaterally
Balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. For those subject who continued the study from 3 months to 6 months, the same treatment was repeated.
|
Senofilcon A Toric/Balafilcon A Toric Contralaterally
Senofilcon A toric lens worn in one eye and Balafilcon A toric lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly. For those subject who continued the study from 3 months to 6 months, the same treatment was repeated.
|
|---|---|---|---|
|
Baseline to Month 3 (Period 1)
Adverse Event
|
4
|
3
|
6
|
|
Baseline to Month 3 (Period 1)
Lost to Follow-up
|
6
|
3
|
13
|
|
Month 3 to Month 6 (Period 2)
Pregnancy
|
0
|
1
|
0
|
Baseline Characteristics
Comparison of Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period
Baseline characteristics by cohort
| Measure |
Senofilcon A Toric Bilaterally
n=36 Participants
senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.
|
Balafilcon A Toric Bilaterally
n=25 Participants
balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.
|
Senofilcon A/Balafilcon A Contralaterally
n=51 Participants
senofilcon A lens worn in one eye and balafilcon A lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly.
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
29.8 years
STANDARD_DEVIATION 6.9 • n=99 Participants
|
30.4 years
STANDARD_DEVIATION 7.8 • n=107 Participants
|
29.6 years
STANDARD_DEVIATION 8.6 • n=206 Participants
|
29.8 years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
79 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
33 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=99 Participants
|
11 participants
n=107 Participants
|
20 participants
n=206 Participants
|
47 participants
n=7 Participants
|
|
Region of Enrollment
Australia
|
20 participants
n=99 Participants
|
14 participants
n=107 Participants
|
31 participants
n=206 Participants
|
65 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: at 3 months of lens wear (period 1)Population: Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis.
Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
Outcome measures
| Measure |
Senofilcon A
n=68 eyes
Senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. OR Senofilcon A Toric worn contralaterally, replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
|
Balafilcon A
n=54 eyes
Balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly OR Balafilcon A Toric worn contralaterally , replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
|
|---|---|---|
|
Corneal Staining
|
0.6 units on a scale
Standard Deviation 0.61
|
0.8 units on a scale
Standard Deviation 0.74
|
PRIMARY outcome
Timeframe: at 3 months of lens wear (period 1)Population: Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis.
Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
Outcome measures
| Measure |
Senofilcon A
n=68 eyes
Senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. OR Senofilcon A Toric worn contralaterally, replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
|
Balafilcon A
n=54 eyes
Balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly OR Balafilcon A Toric worn contralaterally , replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
|
|---|---|---|
|
Limbal Redness
|
0.7 units on a scale
Standard Deviation 0.61
|
0.7 units on a scale
Standard Deviation 0.58
|
PRIMARY outcome
Timeframe: at 3 months of lens wear (period 1)Population: Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis.
Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
Outcome measures
| Measure |
Senofilcon A
n=68 eyes
Senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. OR Senofilcon A Toric worn contralaterally, replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
|
Balafilcon A
n=54 eyes
Balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly OR Balafilcon A Toric worn contralaterally , replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
|
|---|---|---|
|
Bulbar Redness
|
0.9 units on a scale
Standard Deviation 0.58
|
0.8 units on a scale
Standard Deviation 0.57
|
PRIMARY outcome
Timeframe: at 3 months of lens wear (period 1)Population: Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis.
Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
Outcome measures
| Measure |
Senofilcon A
n=68 eyes
Senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. OR Senofilcon A Toric worn contralaterally, replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
|
Balafilcon A
n=54 eyes
Balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly OR Balafilcon A Toric worn contralaterally , replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
|
|---|---|---|
|
Tarsal Roughness
|
1.1 units on a scale
Standard Deviation 0.58
|
1.0 units on a scale
Standard Deviation 0.75
|
Adverse Events
Senofilcon A
Balafilcon A
Serious adverse events
| Measure |
Senofilcon A
n=87 participants at risk
senofilcon A lenses (test) worn daily bilaterally (in both eyes) for 6 months, replaced weekly OR senofilcon A toric lenses worn contralaterally for 6 months, replaced weekly. All enrolled subjects are included. Subjects are counted by device, there are some subjects that are counted in both arms that are from the contralateral group, as identified in the participant flow.
|
Balafilcon A
n=76 participants at risk
balafilcon A lenses (control) worn daily bilaterally (in both eyes) for 6months, replaced weekly OR balifilcon A toric lenses worn contralaterally for 6 months, replaced weekly. All enrolled subjects are included. Subjects are counted by device, there are some subjects that are counted in both arms that are from the contralateral group, as identified in the participant flow.
|
|---|---|---|
|
Eye disorders
Microbial Karatitis
|
0.00%
0/87 • 6 months
|
1.3%
1/76 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
Senofilcon A
n=87 participants at risk
senofilcon A lenses (test) worn daily bilaterally (in both eyes) for 6 months, replaced weekly OR senofilcon A toric lenses worn contralaterally for 6 months, replaced weekly. All enrolled subjects are included. Subjects are counted by device, there are some subjects that are counted in both arms that are from the contralateral group, as identified in the participant flow.
|
Balafilcon A
n=76 participants at risk
balafilcon A lenses (control) worn daily bilaterally (in both eyes) for 6months, replaced weekly OR balifilcon A toric lenses worn contralaterally for 6 months, replaced weekly. All enrolled subjects are included. Subjects are counted by device, there are some subjects that are counted in both arms that are from the contralateral group, as identified in the participant flow.
|
|---|---|---|
|
Eye disorders
Non-Significant Events
|
14.9%
13/87 • Number of events 13 • 6 months
|
11.8%
9/76 • Number of events 9 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication requires agreement and written consent from the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER