Effects of Conventional Dry Eye Treatments on the Ocular Surface Response to Low Humidity Environment in Patients With Keratoconjunctivitis Sicca
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/14/2017 |
| Start Date: | February 2013 |
| End Date: | December 2015 |
Effects of Conventional Dry Eye Treatments on the Ocular Surface Response to Low Humidity Environment in Patients With Keratoconjunctivitis Sicca.
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.
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.
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-KCS 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 HRT, fish oil, evening primrose,
flaxseed, or black current seed oil supplements, antihistamines, cholinergic agents,
beta-blocking agents, tricyclic or SSRI 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
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