Endothelial Bleb Response With Toric Lenses
Study Details
Study Description
Brief Summary
Evaluate the short-term corneal response of oxygen deprivation when using toric contact lenses. The response will be noted by endothelial bleb formation in both open eye and closed eye state.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Interested subjects who meet the entry criteria for the study will be scheduled for four sessions of approximately 30 minutes duration each. Informed consent obtained. Baseline measurements of visual acuity and corneal and conjunctival physiology will be recorded. An examination of the endothelium of the corneas will be conducted using the specular microscope, readings obtained at 5 locations on each cornea: one in the centre and one in each of the superior, inferior, nasal and temporal peripheral regions, approximately 2mm from the limbal margin. The assigned lenses will be inserted according to a fixed-allocation randomization schedule, where each session follows an optimized 2- period simultaneous crossover design, which specifies lenses to be used in each of the four sessions. Lenses will be worn for 20 minutes and then removed. Endothelial specular microscopy will be conducted at 20 minutes with the lenses on. A final evaluation of corneal and conjunctival physiology will be performed prior to subject clearance from the study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Session A Subjects were first randomized to a session and then randomized to receive one of four lens sequences for that session. Each subject participated in all four sessions. Session A only contains senofilcon A toric and alphafilcon A toric lenses. |
Device: alphafilcon A toric
Subjects that were randomized to receive alphafilcon A toric during one of the four sessions (Sessions A, B, C and D).
Device: senofilcon A toric
Subjects that were randomized to receive senofilcon A toric during one of the four sessions (Sessions A, B, C and D).
|
| Other: Session B Subjects were first randomized to a session and then randomized to receive one of four lens sequences for that session. Each subject participated in all four sessions. Session B only contains senofilcon A toric and alphafilcon A toric lenses. |
Device: alphafilcon A toric
Subjects that were randomized to receive alphafilcon A toric during one of the four sessions (Sessions A, B, C and D).
Device: senofilcon A toric
Subjects that were randomized to receive senofilcon A toric during one of the four sessions (Sessions A, B, C and D).
|
| Other: Session C Subjects were first randomized to a session and then randomized to receive one of four lens sequences for that session. Each subject participated in all four sessions. Session C only contains senofilcon A toric and lotrafilcon B toric lenses. |
Device: lotrafilcon B toric
Subjects that were randomized to receive lotrafilcon B toric during one of the four sessions (Sessions A, B, C and D).
Device: senofilcon A toric
Subjects that were randomized to receive senofilcon A toric during one of the four sessions (Sessions A, B, C and D).
|
| Other: Session D Subjects were first randomized to a session and then randomized to receive one of four lens sequences for that session. Each subject participated in all four sessions. Session D only contains senofilcon A toric and lotrafilcon B toric lenses. |
Device: lotrafilcon B toric
Subjects that were randomized to receive lotrafilcon B toric during one of the four sessions (Sessions A, B, C and D).
Device: senofilcon A toric
Subjects that were randomized to receive senofilcon A toric during one of the four sessions (Sessions A, B, C and D).
|
Outcome Measures
Primary Outcome Measures
- Endothelial Bleb Areas on Cornea: Session A- Open Eye [20 minutes post-lens insertion]
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.
- Endothelial Bleb Areas on Cornea: Session B- Closed Eye [20 minutes post-lens insertion]
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.
- Endothelial Bleb Areas on Cornea: Session C- Open Eye [20 minutes post-lens insertion]
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.
- Endothelial Bleb Areas on Cornea: Session D- Closed Eye [20 minutes post-lens insertion]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Successful soft contact lens wear in daily mode for a minimum of 1 month prior to start of the study without experiencing difficulties or contact lens related complications.
-
At least 18 years of age and mentally competent to sign an informed consent form.
-
Healthy eyes and no use of ocular medication.
-
Similarity of optical parameters between eyes.
-
Physical appearance typical of Asian eyes
Exclusion Criteria:
-
A medical or ocular condition that may influence the outcome of this trial.
-
Current use of ocular/systemic medication that may influence the outcome of this trial.
-
Failure to wear soft lenses for 2 weeks prior to the start of the study.
-
Current enrolment or participation in another clinical study.
-
Current state of pregnancy or breastfeeding
-
Anisometropia greater than 1.00D (equivalent sphere).
-
Unequal acuities between eyes (greater than 1 line)
-
Unequal corneal curvatures (>1.00D)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Brennan Consultants 110 Auburn Rd | Auburn Village | Victoria | Australia | 3122 |
Sponsors and Collaborators
- Johnson & Johnson Vision Care, Inc.
Investigators
- Principal Investigator: Noel A Brennan, McOptom PhD, Brennan Consultants
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR-0726
- JJO0717
Study Results
Participant Flow
| Recruitment Details | 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. |
|---|---|
| Pre-assignment Detail | 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). |
| Arm/Group Title | Overall |
|---|---|
| Arm/Group Description | 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. |
| Period Title: Overall Study | |
| STARTED | 37 |
| COMPLETED | 35 |
| NOT COMPLETED | 2 |
Baseline Characteristics
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | All subjects who were enrolled, randomized, and assigned to a study arm. |
| Overall Participants | 37 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
37
100%
|
| >=65 years |
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
25.9
(7.7)
|
| Gender (Count of Participants) | |
| Female |
25
67.6%
|
| Male |
12
32.4%
|
| Region of Enrollment (participants) [Number] | |
| Australia |
37
100%
|
Outcome Measures
| Title | Endothelial Bleb Areas on Cornea: Session A- Open Eye |
|---|---|
| Description | 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. |
| Time Frame | 20 minutes post-lens insertion |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes. |
| Arm/Group Title | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 |
|---|---|---|---|---|
| Arm/Group Description | Subjects that first received senofilcon A in their right eye and then received alphafilcon A in their left eye. | Subjects that first recieved alphafilcon A in their right eye and then received senofilcon A in their left eye. | Subjects that first received senofilcon A in their right eye and then received senofilcon A in their left eye. | Subjects that first received alphafilcon A in their right eye and then received alphafilcon A in their left eye. |
| Measure Participants | 34 | 34 | 34 | 34 |
| Measure Subjects Eyes | 68 | 68 | 68 | 68 |
| Central |
0.1
(0.1)
|
2.0
(0.1)
|
0.2
(0.1)
|
2.1
(0.7)
|
| Inferior |
0.0
(0.0)
|
0.8
(0.3)
|
0.1
(0.0)
|
2.3
(1.0)
|
| Nasal |
0.0
(0.0)
|
0.1
(0.0)
|
0.1
(0.0)
|
0.7
(0.4)
|
| Superior |
0.2
(0.1)
|
0.0
(0.0)
|
0.0
(0.0)
|
0.3
(0.1)
|
| Temporal |
0.0
(0.0)
|
0.1
(0.0)
|
0.1
(0.0)
|
0.4
(0.2)
|
| Title | Endothelial Bleb Areas on Cornea: Session B- Closed Eye |
|---|---|
| Description | 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. |
| Time Frame | 20 minutes post-lens insertion |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes. |
| Arm/Group Title | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 |
|---|---|---|---|---|
| Arm/Group Description | Subjects that first received senofilcon A in their right eye and then received alphafilcon A in their left eye. | Subjects that first recieved alphafilcon A in their right eye and then received senofilcon A in their left eye. | Subjects that first received senofilcon A in their right eye and then received senofilcon A in their left eye. | Subjects that first received alphafilcon A in their right eye and then received alphafilcon A in their left eye. |
| Measure Participants | 34 | 34 | 34 | 34 |
| Measure Subject Eyes | 68 | 68 | 68 | 68 |
| Central |
2.0
(0.9)
|
5.9
(2.5)
|
4.0
(0.9)
|
0.9
(0.5)
|
| Inferior |
0.5
(0.3)
|
3.9
(2.2)
|
2.5
(0.5)
|
0.9
(0.3)
|
| Nasal |
0.5
(0.3)
|
0.9
(0.1)
|
1.0
(0.3)
|
0.1
(0.1)
|
| Superior |
0.1
(0.0)
|
0.2
(0.)
|
10.3
(0.1)
|
0.3
(0.1)
|
| Temporal |
0.2
(0.1)
|
0.5
(0.2)
|
0.5
(0.2)
|
0.3
(0.1)
|
| Title | Endothelial Bleb Areas on Cornea: Session C- Open Eye |
|---|---|
| Description | 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. |
| Time Frame | 20 minutes post-lens insertion |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes. |
| Arm/Group Title | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 |
|---|---|---|---|---|
| Arm/Group Description | Subjects that first received senofilcon A in their right eye and then received lotrafilcon B in their left eye. | Subjects that first recieved lotrafilcon B in their right eye and then received senofilcon A in their left eye. | Subjects that first received senofilcon A in their right eye and then received senofilcon A in their left eye. | Subjects that first received lotrafilcon B in their right eye and then received lotrafilcon B in their left eye. |
| Measure Participants | 34 | 34 | 34 | 34 |
| Measure Subject Eyes | 68 | 68 | 68 | 68 |
| Central |
0.2
(0.1)
|
0.4
(0.3)
|
0.2
(0.1)
|
0.2
(0.1)
|
| Inferior |
0.1
(0.0)
|
0.1
(0.1)
|
0.1
(0.0)
|
0.1
(0.0)
|
| Nasal |
0.1
(0.0)
|
0.1
(0.0)
|
0.1
(0.0)
|
0.2
(0.1)
|
| Superior |
0.1
(0.0)
|
0.0
(0.0)
|
0.0
(0.0)
|
0.4
(0.1)
|
| Temporal |
0.0
(0.0)
|
0.1
(0.0)
|
0.0
(0.0)
|
0.1
(0.0)
|
| Title | Endothelial Bleb Areas on Cornea: Session D- Closed Eye |
|---|---|
| Description | 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. |
| Time Frame | 20 minutes post-lens insertion |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes. |
| Arm/Group Title | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 |
|---|---|---|---|---|
| Arm/Group Description | Subjects that first received senofilcon A in their right eye and then received lotrafilcon B in their left eye. | Subjects that first recieved lotrafilcon B in their right eye and then received senofilcon A in their left eye. | Subjects that first received senofilcon A in their right eye and then received senofilcon A in their left eye. | Subjects that first received lotrafilcon B in their right eye and then received lotrafilcon B in their left eye. |
| Measure Participants | 34 | 34 | 34 | 34 |
| Measure Subject Eyes | 68 | 68 | 68 | 68 |
| Central |
1.7
(0.6)
|
1.6
(0.6)
|
0.5
(0.2)
|
3.5
(2.0)
|
| Inferior |
0.8
(0.3)
|
1.7
(1.0)
|
0.3
(0.1)
|
1.4
(0.7)
|
| Nasal |
0.2
(0.1)
|
0.8
(0.4)
|
0.1
(0.1)
|
0.7
(0.3)
|
| Superior |
0.2
(0.1)
|
0.1
(0.1)
|
0.3
(0.2)
|
0.1
(0.1)
|
| Temporal |
0.1
(0.1)
|
0.2
(0.1)
|
0.1
(0.0)
|
0.3
(0.1)
|
Adverse Events
| Time Frame | Throughout the duration of the study. | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Session A | Session B | Session C | Session D | ||||
| Arm/Group Description | Open eye session, this session includes the following sequences only: senofilcon A / alphafilcon A alphafilcon A / senofilcon A senofilcon A / senofilcon A alphafilcon A / alphafilcon A | Closed eye session, this session includes the following sequences only: senofilcon A/ alphafilcon A alphafilcon A/ senofilcon A senofilcon A/ senofilcon A alphafilcon A/ alphafilcon A | Open eye session, this session includes the following sequences only: senofilcon A/ lotrafilcon B lotrafilcon B / senofilcon A senofilcon A/ senofilcon A lotrafilcon B / lotrafilcon B | Closed eye session, this session includes the following sequences only: senofilcon A/ lotrafilcon B lotrafilcon B / senofilcon A senofilcon A/ senofilcon A lotrafilcon B / lotrafilcon B | ||||
All Cause Mortality |
||||||||
| Session A | Session B | Session C | Session D | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Session A | Session B | Session C | Session D | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/37 (0%) | 0/37 (0%) | 0/37 (0%) | 0/37 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Session A | Session B | Session C | Session D | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/37 (0%) | 0/37 (0%) | 0/37 (0%) | 0/37 (0%) | ||||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Kurt Moody, OD |
|---|---|
| Organization | Johnson & Johnson Vision Care, Inc. |
| Phone | 1-904-443-3088 |
| kmoody1@its.jnj.com |
- CR-0726
- JJO0717