Effects of Dry Eye Treatments on the Ocular Surface

NCT ID: NCT01797822

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2015-12-31

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.

Conditions

Keratoconjunctivitis Sicca; Dry Eye Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Artificial tears first, then Dexamethasone

Artificial tears four times a day both eyes for two weeks, then Dexamethasone 0.01% four times a day both eyes for two weeks

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: DRUG

Artificial tear

Intervention Type: DRUG

Interventions

Dexamethasone

Intervention Type: DRUG

Artificial tear

Intervention Type: DRUG

Other Intervention Names

corticosteroid, vehicle

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Steven Pflugfelder

Professor of Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen Pflugfelder, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Baylor College of Medicine, Alkek Eye Center

Houston, Texas, United States

Countries

United States

Other Identifiers

H-31756

Identifier Type: -

Identifier Source: org_study_id