Effects of Dry Eye Treatments on the Ocular Surface

Baylor College of Medicine

Status and phase

Completed

Phase 4

Conditions

Dry Eye Syndrome

Keratoconjunctivitis Sicca

Treatments

Drug: Dexamethasone

Drug: Artificial tear

Study type

Interventional

Funder types

Other

Identifiers

NCT01797822

H-31756

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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