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| ID | Type | Description | Link |
|---|---|---|---|
| 07-05-034 | Other Identifier | Massachusetts Eye and Ear |
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High number of withdrawals, appt. no-shows, or those lost to follow-up.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyclosporine A 0.05% | Active Comparator | 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. |
|
| Artificial Tear | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclosporine A 0.05% | Drug | Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Staining Score | 18 months | |
| Conjunctival Staining Score | 18 Months | |
| Incidence and Severity of Ocular Adverse Event | Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing. | 18 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom Assessment iN Dry Eye (SANDE) Patient Questionnaire | 18 Months | |
| Tear Break-up Time (TBUT) | 18 Months | |
| Schirmer Without Anesthesia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Reza Dana, M.D. | Massachusetts Eye and Ear Infirmary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts Eye and Ear Infirmary | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Each eye of every participant was 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. Cyclosporine A 0.05% : Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I | 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. Cyclosporine A 0.05% : Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Corneal Staining Score | No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up. | Posted | 18 months |
|
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The adverse events reported are by "eye". Two adverse events were reported: uveitis and bacterial infection. Both these events were bilateral (i.e. both eyes), occurring in two separate subjects.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I | 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. Cyclosporine A 0.05% : Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Uveitis (bilateral) | Eye disorders | Non-systematic Assessment |
The study was terminated early due to a high number of patients who withdrew themselves, failed to show for their appointments, or were lost to follow-up.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Reza Dana, MD, MPH, MSc | Massachusetts Eye and Ear Infirmary | 617-573-3313 | Cornea_Research@MEEI.Harvard.edu |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
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| Arificial Tear | Drug | Artificial Tear - three times a day for 18 months. |
|
|
| 18 Months |
| Schirmer With Anesthesia | 18 Months |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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.
Arificial Tear: Artificial Tear - three times a day for 18 months.
|
| Primary | Conjunctival Staining Score | No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up. | Posted | 18 Months |
|
|
| Primary | Incidence and Severity of Ocular Adverse Event | Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing. | All patients enrolled in the study were analyzed. | Posted | Number | participants | 18 Months |
|
|
|
| Secondary | Symptom Assessment iN Dry Eye (SANDE) Patient Questionnaire | No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up. | Posted | 18 Months |
|
|
| Secondary | Tear Break-up Time (TBUT) | No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up. | Posted | 18 Months |
|
|
| Secondary | Schirmer Without Anesthesia | No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up. | Posted | 18 Months |
|
|
| Secondary | Schirmer With Anesthesia | No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up. | Posted | 18 Months |
|
|
| 0 |
| 8 |
| 2 |
| 8 |
| Bacterial Infection (bilateral) | Eye disorders | Non-systematic Assessment |
|
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| D000602 |
| Amino Acids, Peptides, and Proteins |
| D009883 | Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |