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Keratoconjunctivitis Sicca | Effects of Conventional Dry Eye Treatments on the Ocular Surface Response to Low Humidity Environment in Patients With Keratoconjunctivitis Sicca

Keratoconjunctivitis Sicca research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Keratoconjunctivitis Sicca

Dry Eye Syndrome

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:dexamethasone, artificial tears

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Dexamethasone, artificial tearsDexamethasone 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

Study Status

Completed

Start Date: February 2013

Completed Date: December 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Changes in ocular surface measured by routine opthalmic dyes

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Stephen Pflugfelder, MD

Lead Sponsor: Baylor College of Medicine

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01797822

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