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

Primary Purpose

Dry Eye

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cyclosporin 0.05% emulsion
Endura, Refresh artificial tears
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dry Eye focused on measuring Dry eye, environmental stress, artificial tears, cyclosporin, Restasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alkek Eye Center, Dept of Ophthalmology, Baylor College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cyclosporin 0.05% emulsion

Endura Refresh, Artificial Tears

Arm Description

used in the eye 4 times a day

Over the Counter artificial tears used in the eye 4 times a day

Outcomes

Primary Outcome Measures

Corneal Fluorescein Staining
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

Eye Irritation Symptoms
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.

Full Information

First Posted
July 16, 2014
Last Updated
February 12, 2020
Sponsor
Baylor College of Medicine
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02199964
Brief Title
The Effects of Cyclosporin A in a Low Humidity Environment, on the Ocular Surface
Acronym
CsA
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 Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
Funding was terminated
Study Start Date
March 2014 (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
Collaborators
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
Dry eye, environmental stress, artificial tears, cyclosporin, Restasis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cyclosporin 0.05% emulsion
Arm Type
Experimental
Arm Description
used in the eye 4 times a day
Arm Title
Endura Refresh, Artificial Tears
Arm Type
Active Comparator
Arm Description
Over the Counter artificial tears used in the eye 4 times a day
Intervention Type
Drug
Intervention Name(s)
Cyclosporin 0.05% emulsion
Other Intervention Name(s)
Artificial tears, Cyclosporin 0.05% emulsion (Restasis), Dry Eyes
Intervention Description
Topical therapy for dry eye
Intervention Type
Drug
Intervention Name(s)
Endura, Refresh artificial tears
Other Intervention Name(s)
Dry Eyes, Artificial Tears
Intervention Description
Over the counter therapy for dry eye, used 4 times a day
Primary Outcome Measure Information:
Title
Corneal Fluorescein Staining
Description
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
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Eye Irritation Symptoms
Description
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.
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Conjunctival Goblet Cells
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen C. Pflugfelder, MD
Organizational Affiliation
Baylor College of Medicine, Department of Ophthalmology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alkek Eye Center, Dept of Ophthalmology, Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The study was terminated early because of loss of funding.
Citations:
PubMed Identifier
23572103
Citation
Alex A, Edwards A, Hays JD, Kerkstra M, Shih A, de Paiva CS, Pflugfelder SC. Factors predicting the ocular surface response to desiccating environmental stress. Invest Ophthalmol Vis Sci. 2013 May 7;54(5):3325-32. doi: 10.1167/iovs.12-11322.
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The Effects of Cyclosporin A in a Low Humidity Environment, on the Ocular Surface

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