Dry Eye Syndromes
Conditions
Brief summary
To assess the reading function impairment in patients with dry eye and to assess the effects of reading on the ocular surface.
Detailed description
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.
Interventions
OTHER30 minutes sustained reading
The participants will be given a text to read silently in 30 minutes.
OTHERDry eye exam
Tear break-up time, tear collection, osmolarity, Schirmer test, corneal and conjunctival staining.
Sponsors
Allergan
Johns Hopkins University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* age of 50 or greater, * literacy in English language, * ability to give informed consent
Exclusion criteria
* binocular vision below 20/25, * any ocular surgery within the last 3 months, * mental issues, * illiteracy, * language problems which might possibly interfere with reading ability, * history of taking or current use of topical prescription anti-inflammatory eye drops (including, cyclosporine and steroids as well as any glaucoma eye drops).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained Silent Reading Speed | 30 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Ocular Staining Score (OSS) | Before and after 30 minutes reading | 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. |
| Change in Tear Osmolarity | Before and after 30 minutes reading | — |
| Change in Visual Acuity | 30 minutes | — |
| Cytokines | Tear samples were collected on the day of the exam. The samples were frozen to be assayed upon completion of the study. | Identification of various inflammatory cytokines in tear film of dry eye patients comparing to controls. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Dry Eye Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more | 167 |
| Controls Controls defined as OSDI 12 and less AND total OSS score less than 3 | 33 |
| Total | 200 |
Baseline characteristics
| Characteristic | Dry Eye | Total | Controls |
|---|---|---|---|
| Age, Continuous | 64.1 years STANDARD_DEVIATION 8.7 | 63.7 years STANDARD_DEVIATION 8.3 | 61.4 years STANDARD_DEVIATION 8.7 |
| Baseline Osmolarity | 312 mOsm/L STANDARD_DEVIATION 28 | 311 mOsm/L STANDARD_DEVIATION 26 | 306 mOsm/L STANDARD_DEVIATION 10 |
| Baseline total OSS score | 4.9 scores on a scale of 0 to 12 STANDARD_DEVIATION 3.3 | 4.3 scores on a scale of 0 to 12 STANDARD_DEVIATION 3.4 | 0.9 scores on a scale of 0 to 12 STANDARD_DEVIATION 0.9 |
| Baseline Visual Acuity, logMAR | -0.04 logMAR STANDARD_DEVIATION 0.11 | -0.038 logMAR STANDARD_DEVIATION 0.11 | -0.03 logMAR STANDARD_DEVIATION 0.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 8 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 160 Participants | 192 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 6 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 23 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 6 Participants | 1 Participants |
| Race (NIH/OMB) White | 139 Participants | 163 Participants | 24 Participants |
| Region of Enrollment United States | 167 participants | 200 participants | 33 participants |
| Sex: Female, Male Female | 122 Participants | 141 Participants | 19 Participants |
| Sex: Female, Male Male | 45 Participants | 59 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 167 | 0 / 33 |
| serious Total, serious adverse events | 0 / 167 | 0 / 33 |
Outcome results
Primary
Sustained Silent Reading Speed
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dry Eye | Sustained Silent Reading Speed | 248.4 words/minute | Standard Deviation 79.5 |
| Controls | Sustained Silent Reading Speed | 270.3 words/minute | Standard Deviation 75.3 |
Secondary
Change in Tear Osmolarity
Time frame: Before and after 30 minutes reading
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dry Eye | Change in Tear Osmolarity | 2.7 mOsm/L | Standard Deviation 12.3 |
| Controls | Change in Tear Osmolarity | 1.8 mOsm/L | Standard Deviation 10.9 |
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.
Time frame: Before and after 30 minutes reading
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dry Eye | Change in Total Ocular Staining Score (OSS) | 1.5 units on a scale | Standard Deviation 1.4 |
| Controls | Change in Total Ocular Staining Score (OSS) | 1.1 units on a scale | Standard Deviation 1.2 |
Secondary
Change in Visual Acuity
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dry Eye | Change in Visual Acuity | 0.02 logMAR | Standard Deviation 0.07 |
| Controls | Change in Visual Acuity | 0.02 logMAR | Standard Deviation 0.09 |
Secondary
Cytokines
Identification of various inflammatory cytokines in tear film of dry eye patients comparing to controls.
Time frame: Tear samples were collected on the day of the exam. The samples were frozen to be assayed upon completion of the study.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dry Eye | Cytokines | IFNg | 99.79 pg/mL | Standard Error 16.81 |
| Dry Eye | Cytokines | IL8 | 903.91 pg/mL | Standard Error 268.02 |
| Dry Eye | Cytokines | TNFa | 131.16 pg/mL | Standard Error 54.63 |
| Dry Eye | Cytokines | IL6 | 130.78 pg/mL | Standard Error 39.65 |
| Dry Eye | Cytokines | IL17A | 176.08 pg/mL | Standard Error 28.39 |
| Dry Eye | Cytokines | IL1b | 27.40 pg/mL | Standard Error 5.09 |
| Dry Eye | Cytokines | IL10 | 211.69 pg/mL | Standard Error 30.37 |
| Dry Eye | Cytokines | IL12p70 | 70.89 pg/mL | Standard Error 10.06 |
| Controls | Cytokines | IL12p70 | 131.32 pg/mL | Standard Error 28.59 |
| Controls | Cytokines | IL1b | 27.87 pg/mL | Standard Error 6.47 |
| Controls | Cytokines | IL17A | 200.00 pg/mL | Standard Error 41.42 |
| Controls | Cytokines | IFNg | 150.10 pg/mL | Standard Error 30.29 |
| Controls | Cytokines | IL10 | 304.29 pg/mL | Standard Error 55.01 |
| Controls | Cytokines | TNFa | 107.53 pg/mL | Standard Error 25.3 |
| Controls | Cytokines | IL8 | 157.58 pg/mL | Standard Error 32.39 |
| Controls | Cytokines | IL6 | 69.64 pg/mL | Standard Error 13.4 |