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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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To assess the reading function impairment in patients with dry eye and to assess the effects of reading on the ocular surface.
This study is being done to understand how reading is affected in people with dry eye in comparison with healthy controls and what effect reading has on the ocular surface in patients with dry eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dry Eye | The patients with Sjogren Syndrome related or non-Sjogren Syndrome related dry eye. The participants will be asked some questions. Before and after reading a text silently in 30 minutes "30 minutes sustained reading", a detailed dry eye exam will be performed. |
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| Controls | The patients without dry eye. The participants will be asked some questions. Before and after reading a text silently in 30 minutes "30 minutes sustained reading", a detailed dry eye exam will be performed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 30 minutes sustained reading | Other | The participants will be given a text to read silently in 30 minutes. |
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| Measure | Description | Time Frame |
|---|---|---|
| Sustained Silent Reading Speed | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Ocular Staining Score (OSS) | Ocular staining score (OSS) is sum of the corneal and conjuctival staining scores with a total possible maximum score of 12 for each eye. Corneal staining is graded with a maximum possible fluorescein score of 6 for each cornea (the punctate epithelial erosions grade between 0-3 plus any extra points for modifiers up to 3). Nasal and temporal conjunctiva are graded separately with a score range between 0 and 3 for each area after instillation of lissamine green. An abnormal OSS is defined as being a total score of 3 or more. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with known dry eye as well as normal healthy control subjects with no ocular surface diseases will be recruited from the Ocular Surface Diseases and Dry Eye Clinic as well as Glaucoma Clinic of the Wilmer Eye Institute.
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| Name | Affiliation | Role |
|---|---|---|
| Esen K Akpek, MD | The Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Wilmer Eye Institute, Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
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Ocular staining score (OSS) is sum of the corneal and conjuctival staining scores with a total possible maximum score of 12 for each eye. Corneal staining is graded with a maximum possible fluorescein score of 6 for each eye. Nasal and temporal conjunctiva are graded separately with a lissamine green staining score between 0 and 3 for each area.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dry Eye | Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more |
| FG001 | Controls | Controls defined as OSDI 12 and less AND total OSS score less than 3 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dry Eye | Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more |
| BG001 | Controls | Controls defined as OSDI 12 and less AND total OSS score less than 3 |
| 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, Continuous | Mean |
| 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 | Sustained Silent Reading Speed | Posted | Mean | Standard Deviation | words/minute | 30 minutes |
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Started with the first patient enrollment on 8/7/2013 until the last patient enrollment on 11/5/2015.
The oversight total number of participants at risk was 200. Serious or non-serious adverse events were collected/assessed, but none observed.
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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 | Dry Eye | Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Esen K. Akpek | The Wilmer Eye Institute, Johns Hopkins | 410-955-5214 | esakpek@jhmi.edu |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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Tears
| Dry eye exam | Other | Tear break-up time, tear collection, osmolarity, Schirmer test, corneal and conjunctival staining. |
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| Before and after 30 minutes reading |
| Change in Tear Osmolarity | Before and after 30 minutes reading |
| Change in Visual Acuity | 30 minutes |
| Cytokines | Identification of various inflammatory cytokines in tear film of dry eye patients comparing to controls. | Tear samples were collected on the day of the exam. The samples were frozen to be assayed upon completion of the study. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Baseline Visual Acuity, logMAR | Mean | Standard Deviation | logMAR |
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| Baseline Osmolarity | Mean | Standard Deviation | mOsm/L |
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| Baseline total OSS score | Ocular staining score (OSS) is sum of the corneal and conjuctival staining scores with a total possible maximum score of 12 for each eye. Corneal staining is graded with a maximum possible fluorescein score of 6 for each eye (the punctate epithelial erosions grade between 0-3 plus any extra points for modifiers up to 3). Nasal and temporal conjunctiva are graded separately with a score range between 0 and 3 for each area after instillation of lissamine green. An abnormal OSS is defined as being a total score of 3 or more. | Mean | Standard Deviation | scores on a scale of 0 to 12 |
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| Secondary | Change in Total Ocular Staining Score (OSS) | Ocular staining score (OSS) is sum of the corneal and conjuctival staining scores with a total possible maximum score of 12 for each eye. Corneal staining is graded with a maximum possible fluorescein score of 6 for each cornea (the punctate epithelial erosions grade between 0-3 plus any extra points for modifiers up to 3). Nasal and temporal conjunctiva are graded separately with a score range between 0 and 3 for each area after instillation of lissamine green. An abnormal OSS is defined as being a total score of 3 or more. | Posted | Mean | Standard Deviation | units on a scale | Before and after 30 minutes reading |
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| Secondary | Change in Tear Osmolarity | Posted | Mean | Standard Deviation | mOsm/L | Before and after 30 minutes reading |
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| Secondary | Change in Visual Acuity | Posted | Mean | Standard Deviation | logMAR | 30 minutes |
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| Secondary | Cytokines | Identification of various inflammatory cytokines in tear film of dry eye patients comparing to controls. | The cytokine analysis was performed in the samples of selected participants based on their clinical signs and characteristics. The sample size of the groups was justified using the power analysis. | Posted | Mean | Standard Error | pg/mL | Tear samples were collected on the day of the exam. The samples were frozen to be assayed upon completion of the study. |
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| 0 |
| 167 |
| 0 |
| 167 |
| EG001 | Controls | Controls defined as OSDI 12 and less AND total OSS score less than 3 | 0 | 33 | 0 | 33 |
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| IL6 |
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| IL17A |
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| IL1b |
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| IL8 |
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| IL10 |
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| IL12p70 |
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