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| ID | Type | Description | Link |
|---|---|---|---|
| JJO0717 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Session A | Other | 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. |
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| Session B | Other | 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. |
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| Session C | Other | 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. |
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| Session D | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alphafilcon A toric | Device | Subjects that were randomized to receive alphafilcon A toric during one of the four sessions (Sessions A, B, C and D). |
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| Measure | Description | Time Frame |
|---|---|---|
| Endothelial Bleb Areas on Cornea: Session A- Open Eye | 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. | 20 minutes post-lens insertion |
| Endothelial Bleb Areas on Cornea: Session B- Closed Eye | 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. | 20 minutes post-lens insertion |
| Endothelial Bleb Areas on Cornea: Session C- Open Eye | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noel A Brennan, McOptom PhD | Brennan Consultants | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brennan Consultants 110 Auburn Rd | Auburn Village | Victoria | 3122 | Australia |
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).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All participants who were enrolled and randomized to a trial arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | All subjects who were enrolled, randomized, and assigned to a study arm. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Endothelial Bleb Areas on Cornea: Session A- Open Eye | 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. | The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes. | Posted | Mean | Standard Deviation | Percent Difference of Bleb Area | 20 minutes post-lens insertion | Subjects Eyes | Subjects Eyes |
Throughout the duration of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Session A | Open eye session, this session includes the following sequences only:
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kurt Moody, OD | Johnson & Johnson Vision Care, Inc. | 1-904-443-3088 | kmoody1@its.jnj.com |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| lotrafilcon B toric | Device | Subjects that were randomized to receive lotrafilcon B toric during one of the four sessions (Sessions A, B, C and D). |
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| senofilcon A toric | Device | Subjects that were randomized to receive senofilcon A toric during one of the four sessions (Sessions A, B, C and D). |
|
| 20 minutes post-lens insertion |
| Endothelial Bleb Areas on Cornea: Session D- Closed Eye | 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. | 20 minutes post-lens insertion |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Gender | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| ID | Title | Description |
|---|
| OG000 | Sequence 1 | Subjects that first received senofilcon A in their right eye and then received alphafilcon A in their left eye. |
| OG001 | Sequence 2 | Subjects that first recieved alphafilcon A in their right eye and then received senofilcon A in their left eye. |
| OG002 | Sequence 3 | Subjects that first received senofilcon A in their right eye and then received senofilcon A in their left eye. |
| OG003 | Sequence 4 | Subjects that first received alphafilcon A in their right eye and then received alphafilcon A in their left eye. |
|
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| Primary | Endothelial Bleb Areas on Cornea: Session B- Closed Eye | 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. | The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes. | Posted | Mean | Standard Deviation | Percent Difference of Bleb Area | 20 minutes post-lens insertion | Subject Eyes | Subject Eyes |
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| Primary | Endothelial Bleb Areas on Cornea: Session C- Open Eye | 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. | The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes. | Posted | Mean | Standard Deviation | Percent Difference of Bleb Area | 20 minutes post-lens insertion | Subject Eyes | Subject Eyes |
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| Primary | Endothelial Bleb Areas on Cornea: Session D- Closed Eye | 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. | The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes. | Posted | Mean | Standard Deviation | Percent Difference of Bleb Area | 20 minutes post-lens insertion | Subject Eyes | Subject Eyes |
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| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | Session B | Closed eye session, this session includes the following sequences only:
| 0 | 37 | 0 | 37 |
| EG002 | Session C | Open eye session, this session includes the following sequences only:
| 0 | 37 | 0 | 37 |
| EG003 | Session D | Closed eye session, this session includes the following sequences only:
| 0 | 37 | 0 | 37 |
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| Subject Eyes |
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| Inferior |
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| Nasal |
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| Superior |
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| Temporal |
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| Subject Eyes |
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| Inferior |
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| Nasal |
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| Superior |
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| Temporal |
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| Subject Eyes |
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| Inferior |
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| Nasal |
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| Superior |
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| Temporal |
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