Dry EyePhase 2NCT01393132
Comparative Study of Thymosin Beta 4 Eye Drops vs. Vehicle in the Treatment of Severe Dry Eye
A Phase 2 study testing Thymosin Beta 4 eye drops in people with Dry Eye and Sjogren's Syndrome, run by Michigan Cornea Consultants, PC at 1 site in United States.
Trial summary
Severe dry eye is a debilitating ocular disease resulting in loss of vision, reduced day-to-day function and significant discomfort. Tear substitutes are an important part of the treatment of all patients, however, even with aggressive us, the corneal(ocular)surface often remains very irregular due to poor surface… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Dry Eye, Sjogren's Syndrome, Graft vs. Host Disease
- What is being tested?
- Thymosin Beta 4 eye drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Dec 2012
- Phase
- Phase 2
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Schirmers of < 5 mm at 5 minutes
- TFBUT: less than 10 seconds
- Corneal staining of >3 of 15: conjunctival staining of >3 of 18
- Ocular Surface Disease Index of > 50
- Presumed best corrected vision of 20/60 or better
Who cannot join
- Acute or inflammatory corneal disease
- Pregnancy or lactation
- Monocular status
- Punctal occlusion within 30 days
- Ocular surgery within 3 months
- Corneal thinning of >50%
Show all 10Show fewer
- Active corneal infection
- History of ocular malignancy
- Retinal neovascularization
- Current use of topical cyclosporin A
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan Cornea Consultants, P.C.
Southfield, Michigan, 48034
About this study
Official title: Comparative Study of Thymosin Beta 4 Eye Drops or Vehicle in the Treatment of Patients With Ocular Surface Defects Due to Severe Dry Eye
Severe dry eye is a debilitating ocular disease resulting in loss of vision, reduced day-to-day function and significant discomfort. Tear substitutes are an important part of the treatment of all patients, however, even with aggressive us, the corneal(ocular)surface often remains very irregular due to poor surface healing.
The agent being evaluated in this study, Thymosin Beta 4, promotes healing of the corneal surface and has been studied in patients with recalcitrant corneal ulcers and erosions with significant success (Arch Ophthalmol. 2010;128(5):636-638., Ann of the NY Acad of Sci, May, 2010).
The study hypothesis is that Thymosin Beta 4, in its role as a modulator of corneal surface healing, may be able to promote healing of the corneal surface allowing for more conventional modalities to take over and maintain a smooth and regular ocular surface. The investigators hope to be able to demonstrate an improvement in visual acuity, surface healing and a reduction in dry-eye related symptoms.
Read the detailed description
See above
- Conditions
- Dry Eye, Sjogren's Syndrome, Graft vs. Host Disease
- Being tested
- Thymosin Beta 4 eye drops, Vehicle Control
- Keywords
- Dry Eye, Sjogren's Syndrome, Graft vs. Host Disease, Rheumatoid arthritis, Systemic lupus erythematosus, Scleroderma
- Medical subject headings
- Dry Eye Syndromes, Sjogren's Syndrome, Graft vs Host Disease, Arthritis, Rheumatoid, Lupus Erythematosus, Systemic, Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thymosin Beta 4 eye dropsDrug
Also called Tβ4
Patients will be randomized and will receive the same eye drops the Thymosin Beta 4.
Vehicle ControlDrug
Also called Vehicle
Patients will be randomized and will receive the same eye drops without the Thymosin Beta 4.
| Study group | Role | What they receive |
|---|---|---|
| Thymosin Beta 4 eye drops | Experimental | It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into each eye, six times daily for 28 days Receives: Drug: Thymosin Beta 4 eye drops |
| Vehicle Control | Placebo comparator | It is composed of the same excipients as RGN-259 but does not contain Tβ4 for direct instillation into each eye, six times daily for 28 days. Receives: Drug: Vehicle Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Sum of adverse events observed at Day 1, Day 14, Day 28 and Day 56. Measurable by Intra-ocular pressure (IOP) by applanation tonometry, Complete ophthalmologic evaluation including fundoscopy, An adverse event (baseline and all subsequent study visits).
Measured: Day 1, Day 14, Day 28 and Day 56
Secondary outcomes (3)
Corneal Fluorescein Staining
Ocular surface irregularity as measured by Slit Lamp Examination (SLE) with fluorescein dye staining of the cornea at days 56 (+28 day follow up).
The scale used to determine the difference in corneal fluorescein staining is the Oxford scale. (The Oxford Scale measures corneal fluorescein staining) Corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The five regions were summed, for a maximum score of 25. A higher score represents greater disability.
Measured: Days 56 (+28 day follow up)
Ocular Discomfort Index
Dry eye causes ocular discomfort, which is measured using a Ocular Surface Disease Index at 56 day (+28 day followup).
(Symptomatic improvement using the validated Ocular Surface Disease Index (OSDI).
The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision.
For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time.
OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4].
The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.
Measured: Days 56 (+28 day follow up)
Tear Film Break up Time
Tear film break up time (TFBUT) was measured to evaluating the quality of tear at 56 day (+28 day follow up).
The tear film break-up time is defined as the interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film.
Range : >10 seconds is thought to be normal, <5 seconds low (with high likelihood of dry eye symptoms).
Measured: Days 56 (+28 day follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2012
- Study completionDec 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan Cornea Consultants, PC
- Sponsor type
- University, hospital or other
- Collaborators
- Kresge Eye Institute
- Responsible party
- Principal investigator, Steven P. Dunn, M.D., Michigan Cornea Consultants, PC
- Investigators
- Steven P Dunn, M.D., Principal investigator, Michigan Cornea Consultants, P.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393132
- Sponsor's protocol ID
- 1003008179
- Status last verified
- Dec 2015
- First submitted
- 7 Jul 2011
- Last updated
- 23 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Sosne G, Dunn SP, Kim C. Thymosin beta4 significantly improves signs and symptoms of severe dry eye in a phase 2 randomized trial. Cornea. 2015 May;34(5):491-6. doi: 10.1097/ICO.0000000000000379.
PubMed 25826322
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Thymosin Beta 4 Eye Drops or Vehicle in the Treatment of Patients With Ocular Surface Defects Due to Severe Dry Eye
- ClinicalTrials.gov ID
- NCT01393132
- Acronym / sponsor ID
- 1003008179
- Conditions
- Dry Eye, Sjogren's Syndrome, Graft vs. Host Disease
- Keywords
- Dry Eye, Sjogren's Syndrome, Graft vs. Host Disease, Rheumatoid arthritis, Systemic lupus erythematosus, Scleroderma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Michigan Cornea Consultants, PCUniversity, hospital or other
- Collaborators
- Kresge Eye Institute
- Study start
- Mar 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 Jul 2011 (estimated)
- Results
- Posted 23 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Severe dry eye is a debilitating ocular disease resulting in loss of vision, reduced day-to-day function and significant discomfort. Tear substitutes are an important part of the treatment of all patients, however, even with aggressive us, the corneal(ocular)surface often remains very irregular due to poor surface healing.
The agent being evaluated in this study, Thymosin Beta 4, promotes healing of the corneal surface and has been studied in patients with recalcitrant corneal ulcers and erosions with significant success (Arch Ophthalmol. 2010;128(5):636-638., Ann of the NY Acad of Sci, May, 2010).
The study hypothesis is that Thymosin Beta 4, in its role as a modulator of corneal surface healing, may be able to promote healing of the corneal surface allowing for more conventional modalities to take over and maintain a smooth and regular ocular surface. The investigators hope to be able to demonstrate an improvement in visual acuity, surface healing and a reduction in dry-eye related symptoms.
Detailed description
See above
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thymosin Beta 4 eye drops | Experimental | Drug: Thymosin Beta 4 eye dropsIt is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into each eye, six times daily for 28 days |
| Vehicle Control | Placebo comparator | Drug: Vehicle ControlIt is composed of the same excipients as RGN-259 but does not contain Tβ4 for direct instillation into each eye, six times daily for 28 days. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Schirmers of < 5 mm at 5 minutes
- TFBUT: less than 10 seconds
- Corneal staining of >3 of 15: conjunctival staining of >3 of 18
- Ocular Surface Disease Index of > 50
- Presumed best corrected vision of 20/60 or better
Key exclusion criteria (10 listed)
- Acute or inflammatory corneal disease
- Pregnancy or lactation
- Monocular status
- Punctal occlusion within 30 days
- Ocular surgery within 3 months
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 |
|---|---|---|
| Thymosin Beta 4 eye dropsAlso: Tβ4Patients will be randomized and will receive the same eye drops the Thymosin Beta 4. | Drug | Thymosin Beta 4 eye drops |
| Vehicle ControlAlso: VehiclePatients will be randomized and will receive the same eye drops without the Thymosin Beta 4. | Drug | Vehicle Control |
Primary outcome
Safety
Time frame: Day 1, Day 14, Day 28 and Day 56
Sum of adverse events observed at Day 1, Day 14, Day 28 and Day 56. Measurable by Intra-ocular pressure (IOP) by applanation tonometry, Complete ophthalmologic evaluation including fundoscopy, An adverse event (baseline and all subsequent study visits).
3 secondary outcomes
Corneal Fluorescein Staining
Time frame: Days 56 (+28 day follow up)
Ocular Discomfort Index
Time frame: Days 56 (+28 day follow up)
Tear Film Break up Time
Time frame: Days 56 (+28 day follow up)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25826322Sosne G, Dunn SP, Kim C. Thymosin beta4 significantly improves signs and symptoms of severe dry eye in a phase 2 randomized trial. Cornea. 2015 May;34(5):491-6. doi: 10.1097/ICO.0000000000000379.
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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.
Steven P Dunn, M.D. principal investigator
Michigan Cornea Consultants, P.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thymosin Beta 4 eye drops in people with Dry Eye and Sjogren's Syndrome, run by Michigan Cornea Consultants, PC 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 10 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: finished, as of the sponsor's last update on 23 Dec 2015. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 23 Dec 2015). 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?
Safety (time frame: Day 1, Day 14, Day 28 and Day 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01393132, which also lists 1 linked publication.
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 23 Dec 2015.