Keratoconjunctivitis Sicca, Dry Eye Syndrome
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGDexamethasone
DRUGArtificial tear
Sponsors
Baylor College of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Vehicle and therapy groups were not masked.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Signature on the written informed consent form * Patient motivation and willingness to cooperate with the investigator by following the required medication regimen * Patient willingness and ability to return for all visits during the study * Rapid tear film break up time of seven seconds or less in at least one eye AND * Both cornea fluorescein staining score 3 or greater and conjunctival lissamine green staining 3 or greater in at least one eye * Ocular Surface Disease Index Symptom Severity score of twenty or greater * Tear meniscus height less than or equal to 200um * Intact corneal sensitivity * Willingness to discontinue use of any current dry eye treatment (except artificial tears) for four weeks prior to enrollment, and during the course of the study
Exclusion criteria
* Compromised cognitive ability which may be expected to interfere with study compliance * Uncontrolled or poorly controlled diabetes or heart or pulmonary disease that could, in the judgment of the investigator, jeopardize subject safety or interfere with the interpretation of the results of the study * Known hypersensitivity to any components of the artificial tears or dexamethasone eye drops * Anticipated contact lens wear during the study * History of corneal transplant * Active ocular infection, uveitis or non-Keratoconjunctivitis sicca related inflammation * History of cataract surgery within 3 months prior to enrollment * History of pterygium removal within 6 months prior to enrollment * Reduced corneal sensitivity * Initiation, discontinuation or change in dosage of hormone replacement therapy, fish oil, evening primrose, flaxseed, or black current seed oil supplements, antihistamines, cholinergic agents, beta-blocking agents, tricyclic or selective serotonin reuptake inhibitors, antidepressants, phenothiazines, or topical or systemic acne rosacea medications in two months prior to enrollment, or anticipated change in dosage during course of study * Topical ophthalmic medications within prior 4 weeks, or anticipated use of same during the study (except artificial tears) * Occlusion of the lacrimal puncta either surgically or with temporary collagen punctal plugs within three months prior to study, or anticipated use of same during study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Corneal Fluorescein Staining | Two weeks after treatment and exposure to a low humidity environment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Dexamethasone, Artificial Tears |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Age, Continuous | 54.25 years STANDARD_DEVIATION 14 |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
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.
Time frame: Two weeks after treatment and exposure to a low humidity environment
Population: difference (change) in fluorescein staining pre- and post-exposure to low humidity stress
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artificial Tears | Changes in Corneal Fluorescein Staining | 22.18 units on a scale | Standard Deviation 22.03 |
| Dexamethasone | Changes in Corneal Fluorescein Staining | -3.35 units on a scale | Standard Deviation 18.83 |
p-value: <0.05t-test, 1 sided