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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Baylor College of Medicine
Sponsor:
Information provided by (Responsible Party):
Steven Pflugfelder, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01797822
First received: February 21, 2013
Last updated: March 5, 2014
Last verified: March 2014
  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: 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 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: February 2013
Estimated Primary Completion Date: July 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01797822

Contacts
Contact: Margaret Olfson, COA, CCRP 713-798-8419 molfson@bcm.edu

Locations
United States, Texas
Baylor College of Medicine, Alkek Eye Center Recruiting
Houston, Texas, United States, 77030
Contact: Olfson       molfson@bcm.edu   
Principal Investigator: Stephen Pflugfelder, MD         
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Stephen Pflugfelder, MD Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Steven Pflugfelder, Professor of Ophthalmology, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01797822     History of Changes
Other Study ID Numbers: H-31756
Study First Received: February 21, 2013
Last Updated: March 5, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lacrimal Apparatus Diseases
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Keratoconjunctivitis
Eye Diseases
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Ophthalmic Solutions
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors

ClinicalTrials.gov processed this record on August 01, 2014