Effects of Dry Eye Treatments on the Ocular Surface

NCT01797822 | Completed Phase 4 Results

• 1 other identifier: H-31756
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Keratoconjunctivitis Sicca; Dry Eye Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  Two weeks after treatment and exposure to a low humidity environment

Study Arms (1)

Artificial tears first, then Dexamethasone

EXPERIMENTAL

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; Drug: Artificial tear

Interventions

Dexamethasone DRUG

Also known as: corticosteroid, vehicle

Artificial tears first, then Dexamethasone

Artificial tear DRUG

Artificial tears first, then Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine, Alkek Eye Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Keratoconjunctivitis Sicca; Dry Eye Syndromes

Interventions

Dexamethasone; Adrenal Cortex Hormones; Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Eye Diseases; Keratitis; Corneal Diseases; Lacrimal Apparatus Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Results Point of Contact

• Title: Stephen Pflugfelder
• Organization: Baylor College of Medicine

stevenp@bcm.edu

713-798-6100

Study Officials

• Stephen Pflugfelder, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: Vehicle and therapy groups were not masked.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Ophthalmology

Study Record Dates

• First Submitted: February 21, 2013
• First Posted: February 25, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 5, 2020
• Results First Posted: February 5, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: data is available in a peer reviewed publication
• Access Criteria: data is available in a peer reviewed publication

Locations

US (1)