Effects of Dry Eye Treatments on the Ocular Surface

January 22, 2020 updated by: Steven Pflugfelder, Baylor College of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine, Alkek Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Dexamethasone
Other Names:
  • corticosteroid, vehicle
Drug: Artificial tear

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Corneal Fluorescein Staining
Time Frame: Two weeks after treatment and exposure to a low humidity environment
Subjects will be treated with preservative-free artificial tears for 2 weeks then exposed to a low humidity environment for 90 minutes, then treated with preservative-free dexamethasone 0.1% for 2 weeks and exposed to a low humidity environment again. The change in corneal fluorescein staining before and after the low humidity exposure was measured after each treatment. Fluorescein staining was graded using the CCLR scale (0-100) in 5 zones on the cornea for a maximum score of 500 (range 0-500). A lower change in staining indicates less severe disease in response to the low humidity stress. Negative number indicates staining after exposure was lower than pre.
Two weeks after treatment and exposure to a low humidity environment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Investigators

  • Principal Investigator: Stephen Pflugfelder, MD, Baylor College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

February 21, 2013

First Submitted That Met QC Criteria

February 22, 2013

First Posted (Estimate)

February 25, 2013

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

January 22, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-31756

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The de-identified data was published in a peer reviewed publication

IPD Sharing Time Frame

data is available in a peer reviewed publication

IPD Sharing Access Criteria

data is available in a peer reviewed publication

IPD Sharing Supporting Information Type

  • Study Protocol

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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