Trial Outcomes & Findings for Endothelial Bleb Response With Toric Lenses (NCT NCT00630305)
NCT ID: NCT00630305
Last Updated: 2017-03-03
Results Overview
Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.
COMPLETED
NA
37 participants
20 minutes post-lens insertion
2017-03-03
Participant Flow
Total of 37 subjects enrolled, with two being discontinued. Thirty-five (35) subjects were recruited to a single site, where eligibility was confirmed and informed consent discussed and when appropriate signed.
Subjects were randomized to go to all four sessions (A, B, C and D) in a random order. Once in a session subjects were further randomized to one of four contralteral lens sequences (right eye / left eye).
Participant milestones
| Measure |
Overall
subjects were randomized to a session (A, B, C and D) and then to one of four lens sequences. Each subject participated in every session.
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Overall
subjects were randomized to a session (A, B, C and D) and then to one of four lens sequences. Each subject participated in every session.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Inability to insert contact lens
|
1
|
Baseline Characteristics
Endothelial Bleb Response With Toric Lenses
Baseline characteristics by cohort
| Measure |
All Subjects
n=37 Participants
All subjects who were enrolled, randomized, and assigned to a study arm.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
25.9 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Gender
Female
|
25 Participants
n=5 Participants
|
|
Gender
Male
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 20 minutes post-lens insertionPopulation: The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.
Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.
Outcome measures
| Measure |
Sequence 1
n=68 Subjects Eyes
Subjects that first received senofilcon A in their right eye and then received alphafilcon A in their left eye.
|
Sequence 2
n=68 Subjects Eyes
Subjects that first recieved alphafilcon A in their right eye and then received senofilcon A in their left eye.
|
Sequence 3
n=68 Subjects Eyes
Subjects that first received senofilcon A in their right eye and then received senofilcon A in their left eye.
|
Sequence 4
n=68 Subjects Eyes
Subjects that first received alphafilcon A in their right eye and then received alphafilcon A in their left eye.
|
|---|---|---|---|---|
|
Endothelial Bleb Areas on Cornea: Session A- Open Eye
Central
|
0.1 Percent Difference of Bleb Area
Standard Deviation 0.1
|
2.0 Percent Difference of Bleb Area
Standard Deviation 0.1
|
0.2 Percent Difference of Bleb Area
Standard Deviation 0.1
|
2.1 Percent Difference of Bleb Area
Standard Deviation 0.7
|
|
Endothelial Bleb Areas on Cornea: Session A- Open Eye
Inferior
|
0.0 Percent Difference of Bleb Area
Standard Deviation 0.0
|
0.8 Percent Difference of Bleb Area
Standard Deviation 0.3
|
0.1 Percent Difference of Bleb Area
Standard Deviation 0.0
|
2.3 Percent Difference of Bleb Area
Standard Deviation 1.0
|
|
Endothelial Bleb Areas on Cornea: Session A- Open Eye
Nasal
|
0.0 Percent Difference of Bleb Area
Standard Deviation 0.0
|
0.1 Percent Difference of Bleb Area
Standard Deviation 0.0
|
0.1 Percent Difference of Bleb Area
Standard Deviation 0.0
|
0.7 Percent Difference of Bleb Area
Standard Deviation 0.4
|
|
Endothelial Bleb Areas on Cornea: Session A- Open Eye
Superior
|
0.2 Percent Difference of Bleb Area
Standard Deviation 0.1
|
0.0 Percent Difference of Bleb Area
Standard Deviation 0.0
|
0.0 Percent Difference of Bleb Area
Standard Deviation 0.0
|
0.3 Percent Difference of Bleb Area
Standard Deviation 0.1
|
|
Endothelial Bleb Areas on Cornea: Session A- Open Eye
Temporal
|
0.0 Percent Difference of Bleb Area
Standard Deviation 0.0
|
0.1 Percent Difference of Bleb Area
Standard Deviation 0.0
|
0.1 Percent Difference of Bleb Area
Standard Deviation 0.0
|
0.4 Percent Difference of Bleb Area
Standard Deviation 0.2
|
PRIMARY outcome
Timeframe: 20 minutes post-lens insertionPopulation: The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.
Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.
Outcome measures
| Measure |
Sequence 1
n=68 Subject Eyes
Subjects that first received senofilcon A in their right eye and then received alphafilcon A in their left eye.
|
Sequence 2
n=68 Subject Eyes
Subjects that first recieved alphafilcon A in their right eye and then received senofilcon A in their left eye.
|
Sequence 3
n=68 Subject Eyes
Subjects that first received senofilcon A in their right eye and then received senofilcon A in their left eye.
|
Sequence 4
n=68 Subject Eyes
Subjects that first received alphafilcon A in their right eye and then received alphafilcon A in their left eye.
|
|---|---|---|---|---|
|
Endothelial Bleb Areas on Cornea: Session B- Closed Eye
Central
|
2.0 Percent Difference of Bleb Area
Standard Deviation 0.9
|
5.9 Percent Difference of Bleb Area
Standard Deviation 2.5
|
4.0 Percent Difference of Bleb Area
Standard Deviation 0.9
|
0.9 Percent Difference of Bleb Area
Standard Deviation 0.5
|
|
Endothelial Bleb Areas on Cornea: Session B- Closed Eye
Inferior
|
0.5 Percent Difference of Bleb Area
Standard Deviation 0.3
|
3.9 Percent Difference of Bleb Area
Standard Deviation 2.2
|
2.5 Percent Difference of Bleb Area
Standard Deviation 0.5
|
0.9 Percent Difference of Bleb Area
Standard Deviation 0.3
|
|
Endothelial Bleb Areas on Cornea: Session B- Closed Eye
Nasal
|
0.5 Percent Difference of Bleb Area
Standard Deviation 0.3
|
0.9 Percent Difference of Bleb Area
Standard Deviation 0.1
|
1.0 Percent Difference of Bleb Area
Standard Deviation 0.3
|
0.1 Percent Difference of Bleb Area
Standard Deviation 0.1
|
|
Endothelial Bleb Areas on Cornea: Session B- Closed Eye
Superior
|
0.1 Percent Difference of Bleb Area
Standard Deviation 0.0
|
0.2 Percent Difference of Bleb Area
Standard Deviation 0.
|
10.3 Percent Difference of Bleb Area
Standard Deviation 0.1
|
0.3 Percent Difference of Bleb Area
Standard Deviation 0.1
|
|
Endothelial Bleb Areas on Cornea: Session B- Closed Eye
Temporal
|
0.2 Percent Difference of Bleb Area
Standard Deviation 0.1
|
0.5 Percent Difference of Bleb Area
Standard Deviation 0.2
|
0.5 Percent Difference of Bleb Area
Standard Deviation 0.2
|
0.3 Percent Difference of Bleb Area
Standard Deviation 0.1
|
PRIMARY outcome
Timeframe: 20 minutes post-lens insertionPopulation: The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.
Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.
Outcome measures
| Measure |
Sequence 1
n=68 Subject Eyes
Subjects that first received senofilcon A in their right eye and then received alphafilcon A in their left eye.
|
Sequence 2
n=68 Subject Eyes
Subjects that first recieved alphafilcon A in their right eye and then received senofilcon A in their left eye.
|
Sequence 3
n=68 Subject Eyes
Subjects that first received senofilcon A in their right eye and then received senofilcon A in their left eye.
|
Sequence 4
n=68 Subject Eyes
Subjects that first received alphafilcon A in their right eye and then received alphafilcon A in their left eye.
|
|---|---|---|---|---|
|
Endothelial Bleb Areas on Cornea: Session C- Open Eye
Central
|
0.2 Percent Difference of Bleb Area
Standard Deviation 0.1
|
0.4 Percent Difference of Bleb Area
Standard Deviation 0.3
|
0.2 Percent Difference of Bleb Area
Standard Deviation 0.1
|
0.2 Percent Difference of Bleb Area
Standard Deviation 0.1
|
|
Endothelial Bleb Areas on Cornea: Session C- Open Eye
Inferior
|
0.1 Percent Difference of Bleb Area
Standard Deviation 0.0
|
0.1 Percent Difference of Bleb Area
Standard Deviation 0.1
|
0.1 Percent Difference of Bleb Area
Standard Deviation 0.0
|
0.1 Percent Difference of Bleb Area
Standard Deviation 0.0
|
|
Endothelial Bleb Areas on Cornea: Session C- Open Eye
Nasal
|
0.1 Percent Difference of Bleb Area
Standard Deviation 0.0
|
0.1 Percent Difference of Bleb Area
Standard Deviation 0.0
|
0.1 Percent Difference of Bleb Area
Standard Deviation 0.0
|
0.2 Percent Difference of Bleb Area
Standard Deviation 0.1
|
|
Endothelial Bleb Areas on Cornea: Session C- Open Eye
Superior
|
0.1 Percent Difference of Bleb Area
Standard Deviation 0.0
|
0.0 Percent Difference of Bleb Area
Standard Deviation 0.0
|
0.0 Percent Difference of Bleb Area
Standard Deviation 0.0
|
0.4 Percent Difference of Bleb Area
Standard Deviation 0.1
|
|
Endothelial Bleb Areas on Cornea: Session C- Open Eye
Temporal
|
0.0 Percent Difference of Bleb Area
Standard Deviation 0.0
|
0.1 Percent Difference of Bleb Area
Standard Deviation 0.0
|
0.0 Percent Difference of Bleb Area
Standard Deviation 0.0
|
0.1 Percent Difference of Bleb Area
Standard Deviation 0.0
|
PRIMARY outcome
Timeframe: 20 minutes post-lens insertionPopulation: The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.
Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.
Outcome measures
| Measure |
Sequence 1
n=68 Subject Eyes
Subjects that first received senofilcon A in their right eye and then received alphafilcon A in their left eye.
|
Sequence 2
n=68 Subject Eyes
Subjects that first recieved alphafilcon A in their right eye and then received senofilcon A in their left eye.
|
Sequence 3
n=68 Subject Eyes
Subjects that first received senofilcon A in their right eye and then received senofilcon A in their left eye.
|
Sequence 4
n=68 Subject Eyes
Subjects that first received alphafilcon A in their right eye and then received alphafilcon A in their left eye.
|
|---|---|---|---|---|
|
Endothelial Bleb Areas on Cornea: Session D- Closed Eye
Central
|
1.7 Percent Difference of Bleb Area
Standard Deviation 0.6
|
1.6 Percent Difference of Bleb Area
Standard Deviation 0.6
|
0.5 Percent Difference of Bleb Area
Standard Deviation 0.2
|
3.5 Percent Difference of Bleb Area
Standard Deviation 2.0
|
|
Endothelial Bleb Areas on Cornea: Session D- Closed Eye
Inferior
|
0.8 Percent Difference of Bleb Area
Standard Deviation 0.3
|
1.7 Percent Difference of Bleb Area
Standard Deviation 1.0
|
0.3 Percent Difference of Bleb Area
Standard Deviation 0.1
|
1.4 Percent Difference of Bleb Area
Standard Deviation 0.7
|
|
Endothelial Bleb Areas on Cornea: Session D- Closed Eye
Nasal
|
0.2 Percent Difference of Bleb Area
Standard Deviation 0.1
|
0.8 Percent Difference of Bleb Area
Standard Deviation 0.4
|
0.1 Percent Difference of Bleb Area
Standard Deviation 0.1
|
0.7 Percent Difference of Bleb Area
Standard Deviation 0.3
|
|
Endothelial Bleb Areas on Cornea: Session D- Closed Eye
Superior
|
0.2 Percent Difference of Bleb Area
Standard Deviation 0.1
|
0.1 Percent Difference of Bleb Area
Standard Deviation 0.1
|
0.3 Percent Difference of Bleb Area
Standard Deviation 0.2
|
0.1 Percent Difference of Bleb Area
Standard Deviation 0.1
|
|
Endothelial Bleb Areas on Cornea: Session D- Closed Eye
Temporal
|
0.1 Percent Difference of Bleb Area
Standard Deviation 0.1
|
0.2 Percent Difference of Bleb Area
Standard Deviation 0.1
|
0.1 Percent Difference of Bleb Area
Standard Deviation 0.0
|
0.3 Percent Difference of Bleb Area
Standard Deviation 0.1
|
Adverse Events
Session A
Session B
Session C
Session D
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
- Publication restrictions are in place
Restriction type: OTHER