Dry Eye
Conditions
Keywords
Dry Eye, Graft versus Host Disease, GVHD
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.
Interventions
DRUGCyclosporine A 0.05%
Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months.
DRUGArificial Tear
Artificial Tear - three times a day for 18 months.
Sponsors
Massachusetts Eye and Ear Infirmary
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Staining Score | 18 months | — |
| Conjunctival Staining Score | 18 Months | — |
| Incidence and Severity of Ocular Adverse Event | 18 Months | Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing. |
Secondary
| Measure | Time frame |
|---|---|
| Symptom Assessment iN Dry Eye (SANDE) Patient Questionnaire | 18 Months |
| Schirmer With Anesthesia | 18 Months |
| Tear Break-up Time (TBUT) | 18 Months |
| Schirmer Without Anesthesia | 18 Months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Arm I |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age, Continuous | 43 years STANDARD_DEVIATION 17 |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Conjunctival Staining Score
Time frame: 18 Months
Population: No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.
Primary
Corneal Staining Score
Time frame: 18 months
Population: No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.
Primary
Incidence and Severity of Ocular Adverse Event
Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing.
Time frame: 18 Months
Population: All patients enrolled in the study were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cyclosporine A 0.05% | Incidence and Severity of Ocular Adverse Event | 2 participants |
| Artificial Tear | Incidence and Severity of Ocular Adverse Event | 2 participants |
Secondary
Schirmer With Anesthesia
Time frame: 18 Months
Population: No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.
Secondary
Schirmer Without Anesthesia
Time frame: 18 Months
Population: No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.
Secondary
Symptom Assessment iN Dry Eye (SANDE) Patient Questionnaire
Time frame: 18 Months
Population: No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.
Secondary
Tear Break-up Time (TBUT)
Time frame: 18 Months
Population: No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.