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The purpose of this study is to determine the correct volume of lissamine green to use when assessing conjunctival staining, and to determine the time course needed to evaluate conjunctival staining after lissamine green has been instilled in the eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2.5 microliters lissamine green |
| ||
| 5.0 microliters lissamine green |
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| 10.0 microliters lissamine green |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2.5/5.0/10.0 µL lissamine green | Other | vital stain solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Conjunctival Staining at 1 Minute | Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the "study eye." The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit. | 1 minute after instillation |
| Conjunctival Staining at 2 Minutes | Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the "study eye." The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit. | 2 minutes after instillation |
| Conjunctival Staining at 3 Minutes | Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the "study eye." The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit. | 3 minutes after instillation |
| Conjunctival Staining at 4 Minutes | Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the "study eye." The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit. |
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Inclusion Criteria:
Exclusion Criteria:
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community sample
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Call Center for Trial Locations | Fort Worth | Texas | 76134 | United States |
This reporting group includes all enrolled participants.
30 subjects with conjunctival staining and no other ocular pathology were recruited and enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall | All enrolled participants |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | All enrolled participants |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Conjunctival Staining at 1 Minute | Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the "study eye." The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit. | Analysis conducted per protocol. All subjects participated in each arm/group. | Posted | Mean | Standard Deviation | Units on a scale | 1 minute after instillation |
|
Adverse events were collected for 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 | 2.5 Microliters Lissamine Green | 2.5 microliters lissamine green |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alison Ramsey, O.D., Manager | Alcon Research, Ltd. | 817-551-6986 | Alison.ramsey@alconlabs.com |
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| 4 minutes after instillation |
| Conjunctival Staining at 5 Minutes | Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the "study eye." The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit. | 5 minutes after instillation |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 5.0 Microliters Lissamine Green | 5.0 microliters lissamine green instilled in each eye |
| OG002 | 10.0 Microliters Lissamine Green | 10.0 microliters lissamine green instilled in each eye |
|
|
| Primary | Conjunctival Staining at 2 Minutes | Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the "study eye." The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit. | Analysis conducted per protocol. All subjects participated in each arm/group. | Posted | Mean | Standard Deviation | Units on a scale | 2 minutes after instillation |
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|
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| Primary | Conjunctival Staining at 3 Minutes | Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the "study eye." The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit. | Analysis conducted per protocol. All subjects participated in each arm/group. | Posted | Mean | Standard Deviation | Units on a scale | 3 minutes after instillation |
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| Primary | Conjunctival Staining at 4 Minutes | Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the "study eye." The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit. | Analysis conducted per protocol. All subjects participated in each arm/group. | Posted | Mean | Standard Deviation | Units on a scale | 4 minutes after instillation |
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|
|
| Primary | Conjunctival Staining at 5 Minutes | Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the "study eye." The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit. | Analysis conducted per protocol. All subjects participated in each arm/group. | Posted | Mean | Standard Deviation | Units on a scale | 5 minutes after instillation |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | 5.0 Microliters Lissamine Green | 5.0 microliters lissamine green | 0 | 30 | 0 | 30 |
| EG002 | 10.0 Microliters Lissamine Green | 10.0 microliters lissamine green | 0 | 30 | 0 | 30 |
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