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Effects of Dry Eye Treatments on the Ocular Surface

Primary Purpose

Keratoconjunctivitis Sicca, Dry Eye Syndrome

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Dexamethasone

Artificial tear

About this trial

This is an interventional treatment trial for Keratoconjunctivitis Sicca

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Baylor College of Medicine, Alkek Eye Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Artificial tears first, then Dexamethasone

Arm Description

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

Outcomes

Primary Outcome Measures

Changes in Corneal Fluorescein Staining

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01797822

First Posted

February 21, 2013

Last Updated

January 22, 2020

Sponsor

Baylor College of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT01797822

Brief Title

Effects of Dry Eye Treatments on the Ocular Surface

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

February 2013 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Baylor College of Medicine

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Keratoconjunctivitis Sicca, Dry Eye Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Masking Description

Vehicle and therapy groups were not masked.

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Artificial tears first, then Dexamethasone

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Other Intervention Name(s)

corticosteroid, vehicle

Intervention Type

Drug

Intervention Name(s)

Artificial tear

Primary Outcome Measure Information:

Title

Changes in Corneal Fluorescein Staining

Description

Time Frame

Two weeks after treatment and exposure to a low humidity environment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephen Pflugfelder, MD

Organizational Affiliation

Baylor College of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Baylor College of Medicine, Alkek Eye Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

Effects of Dry Eye Treatments on the Ocular Surface

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