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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01797822
First Posted: February 25, 2013
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Steven Pflugfelder, Baylor College of Medicine
  Purpose

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.


Condition Intervention
Keratoconjunctivitis Sicca Dry Eye Syndrome Drug: dexamethasone, artificial tears

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Conventional Dry Eye Treatments on the Ocular Surface Response to Low Humidity Environment in Patients With Keratoconjunctivitis Sicca.

Resource links provided by NLM:


Further study details as provided by Steven Pflugfelder, Baylor College of Medicine:

Primary Outcome Measures:
  • Changes in ocular surface measured by routine opthalmic dyes [ Time Frame: Two weeks after treatment and exposure to a low humidity environment ]
    Subjects will be exposed to a low humidity environment at initial examination and then after two weeks of using artificial tears, and lastly after two weeks of using dexamethasone. The changes in the ocular surface will be measured after each exposure to a low humidity environment.


Enrollment: 4
Study Start Date: February 2013
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: dexamethasone, artificial tears

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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-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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01797822


Locations
United States, Texas
Baylor College of Medicine, Alkek Eye Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Stephen Pflugfelder, MD Baylor College of Medicine
  More Information

Responsible Party: Steven Pflugfelder, Professor of Ophthalmology, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01797822     History of Changes
Other Study ID Numbers: H-31756
First Submitted: February 21, 2013
First Posted: February 25, 2013
Last Update Posted: October 12, 2017
Last Verified: January 2016

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Dexamethasone acetate
Dexamethasone
BB 1101
Lubricant Eye Drops
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Ophthalmic Solutions
Pharmaceutical Solutions