Effects of Dry Eye Treatments on the Ocular Surface
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|ClinicalTrials.gov Identifier: NCT01797822|
Recruitment Status : Completed
First Posted : February 25, 2013
Results First Posted : February 5, 2020
Last Update Posted : February 5, 2020
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 or disease||Intervention/treatment||Phase|
|Keratoconjunctivitis Sicca Dry Eye Syndrome||Drug: Dexamethasone Drug: Artificial tear||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Vehicle and therapy groups were not masked.|
|Official Title:||Effects of Conventional Dry Eye Treatments on the Ocular Surface Response to Low Humidity Environment in Patients With Keratoconjunctivitis Sicca.|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
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
Other Name: corticosteroid, vehicle
Drug: Artificial tear
- 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.
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
|United States, Texas|
|Baylor College of Medicine, Alkek Eye Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Stephen Pflugfelder, MD||Baylor College of Medicine|