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The purpose of this study is to evaluate whether, in people with dry eye syndrome, over the counter artificial tears and the prescription eye drop, dexamethasone, change or effect the eyes response to a low humidity environment.
It is known that irritation from dry eye can be improved by over the counter artificial tears because they wet and lubricate the eyes. The prescription eye drop, dexamethasone, can also improve eye irritation by decreasing the inflammation that develops in dry eye. Thus, the investigators hypothesize that the use of these conventional dry eye treatments will improve the eyes' response to a low humidity environment.
This study evaluated the effects of the corticosteroid dexamethasone on suppressing development of eye irritation, cornea epithelial disease and increased production of inflammatory mediators in subjects who were subjected to an experimental low humidity drafty environment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artificial tears first, then Dexamethasone | Experimental | Artificial tears four times a day both eyes for two weeks, then Dexamethasone 0.01% four times a day both eyes for two weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Corneal Fluorescein Staining | Subjects will be treated with preservative-free artificial tears for 2 weeks then exposed to a low humidity environment for 90 minutes, then treated with preservative-free dexamethasone 0.1% for 2 weeks and exposed to a low humidity environment again. The change in corneal fluorescein staining before and after the low humidity exposure was measured after each treatment. Fluorescein staining was graded using the CCLR scale (0-100) in 5 zones on the cornea for a maximum score of 500 (range 0-500). A lower change in staining indicates less severe disease in response to the low humidity stress. Negative number indicates staining after exposure was lower than pre. | Two weeks after treatment and exposure to a low humidity environment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Pflugfelder, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine, Alkek Eye Center | Houston | Texas | 77030 | United States |
The de-identified data was published in a peer reviewed publication
data is available in a peer reviewed publication
data is available in a peer reviewed publication
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| ID | Title | Description |
|---|---|---|
| FG000 | Artificial Tears First, Then Dexamethasone 0.01% | Artificial tears four times a day for two weeks in both eyes, then Dexamethasone 0.01% ophthalmic solution four times a day for two weeks in both eyes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexamethasone, Artificial Tears | Dexamethasone 0.01% ophthalmic solution four times a day for two weeks in both eyes Artificial tears four times a day for two weeks in both eyes dexamethasone, artificial tears |
| 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 | Changes in Corneal Fluorescein Staining | Subjects will be treated with preservative-free artificial tears for 2 weeks then exposed to a low humidity environment for 90 minutes, then treated with preservative-free dexamethasone 0.1% for 2 weeks and exposed to a low humidity environment again. The change in corneal fluorescein staining before and after the low humidity exposure was measured after each treatment. Fluorescein staining was graded using the CCLR scale (0-100) in 5 zones on the cornea for a maximum score of 500 (range 0-500). A lower change in staining indicates less severe disease in response to the low humidity stress. Negative number indicates staining after exposure was lower than pre. | difference (change) in fluorescein staining pre- and post-exposure to low humidity stress | Posted | Mean | Standard Deviation | units on a scale | Two weeks after treatment and exposure to a low humidity environment |
|
18 months
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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 | Dexamethasone | Dexamethasone 0.01% ophthalmic solution four times a day for two weeks in both eyes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen Pflugfelder | Baylor College of Medicine | 713-798-6100 | stevenp@bcm.edu |
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| ID | Term |
|---|---|
| D007638 | Keratoconjunctivitis Sicca |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007637 | Keratoconjunctivitis |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D000305 | Adrenal Cortex Hormones |
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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Vehicle and therapy groups were not masked.
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| Artificial tear |
| Drug |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Artificial tears four times a day for two weeks in both eyes/Artificial tears |
| OG001 | Dexamethasone | Dexamethasone 4 times per day for 2 weeks in both eyes/Dexamethasone |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Artificial Tear | Artificial tears four times a day for two weeks in both eyes | 0 | 20 | 0 | 20 | 0 | 20 |
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| D007634 |
| Keratitis |
| D003316 | Corneal Diseases |
| D007766 | Lacrimal Apparatus Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009883 | Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |