Dry EyePhase 4NCT00553735
The Prophylactic Use of Topical Cyclosporine A 0.05% to Prevent Graft Versus Host Disease Related Dry Eye
A Phase 4 study testing Cyclosporine A 0.05% and Arificial Tear in people with Dry Eye, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- Cyclosporine A 0.05% and Arificial Tear
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Dec 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
About this study
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
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.
Read the 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.
- Conditions
- Dry Eye
- Being tested
- Cyclosporine A 0.05%, Arificial Tear
- Keywords
- Dry Eye, Graft versus Host Disease, GVHD
- Medical subject headings
- Dry Eye Syndromes, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporine A 0.05%Drug
Also called Restasis
Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months.
Arificial TearDrug
Also called Placebo, Artificial Tear
Artificial Tear - three times a day for 18 months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Cyclosporine A 0.05% |
| 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. Receives: Drug: Arificial Tear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Staining Score
Measured: 18 months
Conjunctival Staining Score
Measured: 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.
Measured: 18 Months
Secondary outcomes (4)
Symptom Assessment iN Dry Eye (SANDE) Patient Questionnaire
Measured: 18 Months
Tear Break-up Time (TBUT)
Measured: 18 Months
Schirmer Without Anesthesia
Measured: 18 Months
Schirmer With Anesthesia
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2007 (estimated)
- Study startAug 2007
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: High number of withdrawals, appt. no-shows, or those lost to follow-up.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reza Dana, M.D., Principal investigator, Massachusetts Eye and Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553735
- Sponsor's protocol ID
- 07-05-034
- Other IDs
- 07-05-034
- Status last verified
- Apr 2013
- First submitted
- 2 Nov 2007
- Last updated
- 28 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00553735
- Acronym / sponsor ID
- 07-05-034
- Conditions
- Dry Eye
- Keywords
- Dry Eye, Graft versus Host Disease, GVHD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: High number of withdrawals, appt. no-shows, or those lost to follow-up.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 6 Nov 2007 (estimated)
- Results
- Posted 28 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyclosporine A 0.05% | Active comparator | Drug: Cyclosporine A 0.05%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 | Drug: Arificial TearIf 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclosporine A 0.05%Also: RestasisTopical cyclosporine A 0.05% (Restasis) three times a day for 18 months. | Drug | Cyclosporine A 0.05% |
| Arificial TearAlso: Placebo, Artificial TearArtificial Tear - three times a day for 18 months. | Drug | Artificial Tear |
Primary outcome
Corneal Staining Score
Time frame: 18 months
Conjunctival Staining Score
Time frame: 18 Months
Incidence and Severity of Ocular Adverse Event
Time frame: 18 Months
Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing.
4 secondary outcomes
Symptom Assessment iN Dry Eye (SANDE) Patient Questionnaire
Time frame: 18 Months
Tear Break-up Time (TBUT)
Time frame: 18 Months
Schirmer Without Anesthesia
Time frame: 18 Months
Schirmer With Anesthesia
Time frame: 18 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reza Dana, M.D. principal investigator
Massachusetts Eye and Ear Infirmary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cyclosporine A 0.05% and Arificial Tear in people with Dry Eye, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal Staining Score (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2017.