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The Effects of Cyclosporin A in a Low Humidity Environment, on the Ocular Surface (CsA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02199964
Recruitment Status : Terminated (Funding was terminated)
First Posted : July 25, 2014
Results First Posted : February 5, 2020
Last Update Posted : February 20, 2020
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Steven Pflugfelder, Baylor College of Medicine

Brief Summary:
This study will test that hypothesis that topical administration of the FDA approved immunomodulatory agent cyclosporin A emulsion will minimize irritation and ocular surface disease that results from a short term low humidity environmental stress

Condition or disease Intervention/treatment Phase
Dry Eye Drug: Cyclosporin 0.05% emulsion Drug: Endura, Refresh artificial tears Not Applicable

Detailed Description:
This is a pilot study designed to evaluate the effect of two conventional dry eye therapies, artificial tears to hydrate and cyclosporine A as an anti-inflammatory, on the irritation symptoms and ocular surface disease of dry eye patients who will be exposed to a low humidity environment for 90 minutes. Patients with dry eye will be enrolled in this study and complete a validated symptom questionnaire and then undergo a complete ocular surface and tear examination to characterize their disease. Enrolled subjects will be exposed to a low humidity environment at the initial evaluation prior to any treatment and will be exposed to a low humidity environment for a second time. They will be randomized to receive either artificial tears or 0.05% cyclosporine A emulsion drop four times a day for 6 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Effects of Cyclosporin A Emulsion, (Restasis), on the Ocular Surface in Response to Low Humidity Environment in Patients With Dry Eye
Study Start Date : March 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Experimental: Cyclosporin 0.05% emulsion
used in the eye 4 times a day
Drug: Cyclosporin 0.05% emulsion
Topical therapy for dry eye
Other Names:
  • Artificial tears
  • Cyclosporin 0.05% emulsion (Restasis)
  • Dry Eyes

Active Comparator: Endura Refresh, Artificial Tears
Over the Counter artificial tears used in the eye 4 times a day
Drug: Endura, Refresh artificial tears
Over the counter therapy for dry eye, used 4 times a day
Other Names:
  • Dry Eyes
  • Artificial Tears




Primary Outcome Measures :
  1. Corneal Fluorescein Staining [ Time Frame: 6 weeks ]
    The mean difference in corneal staining using the adjusted CCLR global staining score before and after the environmental challenge at visits baseline and Visit 3/Day 42 when patients were subjected to a 90-minute low humidity stress. Corneal fluorescein staining was graded 0-100 in 5 zones on the cornea. The scores ranged from 0 (minimum) to 500 (maximum). A higher score indicates there was greater cornea disease induced by the low humidity stress on Day 42


Secondary Outcome Measures :
  1. Eye Irritation Symptoms [ Time Frame: 6 weeks ]
    The mean difference in subject's scoring of eye irritation symptoms using a VAS (visual analog scale) questionnaire before and after the environmental challenge after treatment at Visit 3/Day 42 when patients were subjected to a 90-minute low humidity stress. Symptoms were graded on a 4 question VAS 0-5 for each question, with scores summed for all questions for a total score that ranges from 0 (minimum) to 20 (maximum) for the pre and post challenge questionnaires. The outcome measure is the difference in the post to pre total score ranging from -20 (maximum improvement) to 20 (maximum worsening). A minus difference indicated the subject had lower irritation symptoms following the lower humidity challenge, while a positive difference indicated the subject had greater irritation following the low humidity challenge on Day 42.


Other Outcome Measures:
  1. Conjunctival Goblet Cells [ Time Frame: 6 weeks ]
    The number of conjunctival goblet cells measured in impression cytology at screening/baseline before and after low humidity exposure at the baseline and Day 42 visits. No (zero) subjects were analyzed because the assay was not performed and data was not collected because the study was terminated due to loss of funding.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signature on the written informed consent form
  • 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 greater than or equal to 3 and conjunctival lissamine green staining greater than or equal to 3 in at least one eye
  • Ocular Surface Disease Index Symptom Severity score of twenty or greater
  • Tear meniscus height less than or equal to 230um
  • 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 cyclosporin A 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 hormone replacement therapy (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

Information from the National Library of Medicine

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): NCT02199964


Locations
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United States, Texas
Alkek Eye Center, Dept of Ophthalmology, Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Allergan
Investigators
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Principal Investigator: Stephen C. Pflugfelder, MD Baylor College of Medicine, Department of Ophthalmology
Publications:
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Responsible Party: Steven Pflugfelder, Director of Ocular Surface Clinical Trials, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02199964    
Other Study ID Numbers: H-33276
First Posted: July 25, 2014    Key Record Dates
Results First Posted: February 5, 2020
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The study was terminated early because of loss of funding.
Keywords provided by Steven Pflugfelder, Baylor College of Medicine:
Dry eye
environmental stress
artificial tears
cyclosporin
Restasis
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Cyclosporine
Lubricant Eye Drops
Cyclosporins
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Ophthalmic Solutions
Pharmaceutical Solutions