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The Prophylactic Use of Topical Cyclosporine A 0.05% to Prevent Graft Versus Host Disease Related Dry Eye

Primary Purpose

Dry Eye

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Cyclosporine A 0.05%
Arificial Tear
Sponsored by
Massachusetts Eye and Ear Infirmary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dry Eye focused on measuring Dry Eye, Graft versus Host Disease, GVHD

Eligibility Criteria

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

Inclusion Criteria:

  • Male or female
  • At least 18 years of age
  • Approved candidate for allogeneic HSCT
  • Ability to understand and provide informed consent to participate in this study
  • Willingness to follow study instructions and likely to complete all required visits

Exclusion Criteria:

  • History of ocular or eyelid surgery
  • History of glaucoma or ocular hypertension
  • History of herpetic eye disease
  • Patient with acne rosacea, blepharitis, or meibomitis, in the opinion of the investigator
  • Any ocular disorder or condition (including ocular infection, trauma, and disease) that could possibly interfere with the interpretation of the study results
  • Recent (3-month) history of wearing contact lens
  • Anticipated contact lens wear during any portion of the study
  • Recent (3-month) history of current use of topical steroids or antiglaucoma agents
  • Any punctal occlusion within 2 months of the screening visit
  • Significant sign or symptoms of dry eye (the definition of "dry eye" used for exclusion criteria is compatible with the recommendations of the NEI/Industry Workshop on Clinical Trials in Dry Eyes (Lemp, 1995) (see Appendix 1and 2))
  • History of connective tissue disease or diabetes
  • Any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study

Sites / Locations

  • Massachusetts Eye and Ear Infirmary

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Cyclosporine A 0.05%

Artificial Tear

Arm Description

If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear) The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.

If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear) The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.

Outcomes

Primary Outcome Measures

Corneal Staining Score
Conjunctival Staining Score
Incidence and Severity of Ocular Adverse Event
Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing.

Secondary Outcome Measures

Symptom Assessment iN Dry Eye (SANDE) Patient Questionnaire
Tear Break-up Time (TBUT)
Schirmer Without Anesthesia
Schirmer With Anesthesia

Full Information

First Posted
November 2, 2007
Last Updated
February 7, 2017
Sponsor
Massachusetts Eye and Ear Infirmary
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1. Study Identification

Unique Protocol Identification Number
NCT00553735
Brief Title
The Prophylactic Use of Topical Cyclosporine A 0.05% to Prevent Graft Versus Host Disease Related Dry Eye
Official Title
The Prophylactic Use of Topical Cyclosporine A 0.05% (Restasis) to Prevent Onset and Progression of Graft-versus-host Disease-related Dry Eye
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Terminated
Why Stopped
High number of withdrawals, appt. no-shows, or those lost to follow-up.
Study Start Date
August 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Massachusetts Eye and Ear Infirmary

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether Restasis is an effective treatment for preventing the occurrence and progression of dry eye syndrome in patients who have recently received a bone marrow transplant and are at risk to graft-versus-host disease.
Detailed Description
The purpose of this research study is to determine if early treatment using Restasis eye drops can prevent the development or delay the progression of dry eye syndrome in allogeneic bone marrow transplant (BMT) recipients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
Dry Eye, Graft versus Host Disease, GVHD

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cyclosporine A 0.05%
Arm Type
Active Comparator
Arm Description
If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear) The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.
Arm Title
Artificial Tear
Arm Type
Placebo Comparator
Arm Description
If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear) The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.
Intervention Type
Drug
Intervention Name(s)
Cyclosporine A 0.05%
Other Intervention Name(s)
Restasis
Intervention Description
Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months.
Intervention Type
Drug
Intervention Name(s)
Arificial Tear
Other Intervention Name(s)
Placebo, Artificial Tear
Intervention Description
Artificial Tear - three times a day for 18 months.
Primary Outcome Measure Information:
Title
Corneal Staining Score
Time Frame
18 months
Title
Conjunctival Staining Score
Time Frame
18 Months
Title
Incidence and Severity of Ocular Adverse Event
Description
Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing.
Time Frame
18 Months
Secondary Outcome Measure Information:
Title
Symptom Assessment iN Dry Eye (SANDE) Patient Questionnaire
Time Frame
18 Months
Title
Tear Break-up Time (TBUT)
Time Frame
18 Months
Title
Schirmer Without Anesthesia
Time Frame
18 Months
Title
Schirmer With Anesthesia
Time Frame
18 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female At least 18 years of age Approved candidate for allogeneic HSCT Ability to understand and provide informed consent to participate in this study Willingness to follow study instructions and likely to complete all required visits Exclusion Criteria: History of ocular or eyelid surgery History of glaucoma or ocular hypertension History of herpetic eye disease Patient with acne rosacea, blepharitis, or meibomitis, in the opinion of the investigator Any ocular disorder or condition (including ocular infection, trauma, and disease) that could possibly interfere with the interpretation of the study results Recent (3-month) history of wearing contact lens Anticipated contact lens wear during any portion of the study Recent (3-month) history of current use of topical steroids or antiglaucoma agents Any punctal occlusion within 2 months of the screening visit Significant sign or symptoms of dry eye (the definition of "dry eye" used for exclusion criteria is compatible with the recommendations of the NEI/Industry Workshop on Clinical Trials in Dry Eyes (Lemp, 1995) (see Appendix 1and 2)) History of connective tissue disease or diabetes Any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Dana, M.D.
Organizational Affiliation
Massachusetts Eye and Ear Infirmary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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The Prophylactic Use of Topical Cyclosporine A 0.05% to Prevent Graft Versus Host Disease Related Dry Eye

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