Dry Eye SyndromePhase 1NCT02369861
Study of ST266 Eye Drops in Treating Dry Eye
A Phase 1 study testing ST266 and Refresh Lubricant Eye Drops in people with Dry Eye Syndrome, run by Noveome Biotherapeutics, formerly Stemnion at 1 site in United States.
Trial summary
Subjects with moderate-to-severe Dry Eye by symptoms will be screened including history, ophthalmic examination to include the status of their ocular structure and function and evaluation of tear production. Blood will be blood drawn for complete blood count and chemistry panel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- ST266 and Refresh Lubricant Eye Drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Dec 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Subjects ages 18 years and older.
- Subjects with symptoms and signs of Dry Eye for > four months supported by previous clinical diagnosis or self-reported history.
- Visual acuity corrected 20/40 or better in each eye.
- If wearing contact lenses, subjects must be willing to refrain from wearing the contact lenses during the study (including washout period).
- Score of 25-75 on the Ocular Surface Disorder Index (OSDI) questionnaire.
- Corneal staining of grade 2 or more anywhere on the cornea (scale 0-4).
Who cannot join
- Pregnant or breast feeding.
- Anterior segment disease other than Dry Eye which in the opinion of the investigator would confound the study.
- Macular and neovascular eye diseases
- History of corneal surgery or LASIK (laser in situ keratomileusis) surgery in either eye within the past year.
- Use of cyclosporine, steroid eye drops, serum eye drops, or any other eye medication (except for artificial tears) or experimental drug within the past 30 days.
- Subjects with glaucoma or in whom glaucoma is suspected.
Show all 13Show fewer
- Use of anticholinergic drugs, antihistamines, beta-blockers, or tricyclic anti-depressants within the past 30 days.
- Asymmetric punctal plugs or punctal cauterization within the past three months.
- History of Stevens-Johnson disease, ocular cicatricial pemphigoid, alkali burn of the eye, or graft-versus-host disease.
- Immune compromise for any reason.
- Kidney or liver function studies >2x the upper limit of normal.
- Symptomatic abnormalities od the lid.
- History of cancer within the past 5 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Masked, Active Placebo-controlled Phase 1 Study of Amnion-derived Cellular Cytokine Solution (ACCS) Eye Drops in the Treatment of Dry Eye
Subjects with moderate-to-severe Dry Eye by symptoms will be screened including history, ophthalmic examination to include the status of their ocular structure and function and evaluation of tear production. Blood will be blood drawn for complete blood count and chemistry panel. They will also have a urinalysis and pregnancy test in women of child-bearing potential.
Subjects will have a two week "run-in" period in which they use artificial tears. If their Dry Eye signs and symptoms do not improve significantly, they will be enrolled and will receive study drug.
Read more
Safety evaluation includes assessment of the structure and function of the eyes including retina examination and corrected visual acuity.
Subjects who meet the inclusion and exclusion criteria will be randomly assigned to one of two treatment arms, ST266 or "artificial tears" eye drops. The randomization scheme is 1:1 ST266:artificial tears. Subjects will self-administer their eye drops four times each day.
Subjects will be seen in the office of the ophthalmologist/optometrist at baseline (week zero), one week, three weeks, six weeks and ten weeks. Eye examination will be done at each visit. The baseline eye tests and lab work will be repeated after the treatment phase of the study at the end of week six. Following 6 weeks of treatment, the subjects will be followed for 4 additional weeks.
Read the detailed description
Subjects with moderate-to-severe Dry Eye judged by symptoms will be screened following signing of informed consent. Screening will involve history and physical examination including ophthalmic examination with dilated fundus exam to assess the status of their ocular structure and function, and evaluation of tear production and damage caused by clinically significant Dry Eye. Blood will be blood drawn for complete blood count, chemistry panel including serum glucose, blood urea nitrogen, electrolytes, creatinine, liver function studies including total and direct bilirubin, alkaline phosphatase, alanine transaminase (ALT), aspartate transaminase (AST), albumin, and total protein. They will also have a urinalysis. Pregnancy test will be performed in women of child-bearing potential.
Subjects will have a two week "run-in" period in which they use artificial tears. Those subjects in whom corneal staining is 2 or more (on a scale of 0-4), Dry Eye symptom score on the OSDI is 25-75 after two weeks of using artificial tears four times per day, and laboratory test results within the accepted ranges will be enrolled and will receive study drug, Those subjects in whom dry eye symptoms improve sufficiently (OSDI drops below 25) and/or corneal staining is reduced from 2 or more to less than 2, or have laboratory test results outside the accepted ranges will not be enrolled.
Safety evaluation includes assessment of the structure and function of the eyes including conjunctival and corneal tissues. Corrected visual acuity will be measured at every visit. Patient comfort will be assessed after administration of the study drug and at every visit. A retina examination will be performed before and after the treatment period. Slit lamp exam including the cornea, conjunctiva, anterior chamber, iris, eye lids and lashes will be performed at every visit. Special testing will include fluorescein staining of the cornea, lissamine green staining of the conjunctiva, endothelial cell analysis, Schirmer tear production, and intraocular pressure measured on all subjects.
Subjects who meet the inclusion and exclusion criteria will be randomly assigned to one of two treatment arms, ST266 or "artificial tears" eye drops. ST266 and artificial tears eye drops will be supplied by Stemnion, and both personnel and subjects will be trained in its use. The treatment will be prepared in a coded container such that the subject and physician are masked as to the treatment. One treatment arm will receive ST266 eye drops in both eyes and the other treatment arm will receive artificial tears eye drops in both eyes. Treatment arms will be assigned by random. The randomization scheme is 1:1 ST266:artificial tears. Subjects will self-administer their eye drops four times each day. Subjects will be asked to keep a study diary of when they place the study medication in their eyes.
Subjects will be seen in the office of the ophthalmologist/optometrist at baseline (week zero), one week, three weeks, six weeks and ten weeks. Eye examination will be done at each visit. Each subject will complete a patient questionnaire on their symptoms of Dry Eye. The baseline eye tests and lab work will be repeated after the treatment phase of the study at the end of week six. Following 6 weeks of treatment, the subjects will be followed for 4 additional weeks.
- Conditions
- Dry Eye Syndrome
- Being tested
- ST266, Refresh Lubricant Eye Drops
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ST266Drug
Topical ocular application 4 times per day
Refresh Lubricant Eye DropsDrug
Topical ocular application 4 timer per day
| Study group | Role | What they receive |
|---|---|---|
| ST266 | Experimental | Eye drops Receives: Drug: ST266 |
| Artificial tears | Placebo comparator | Refresh lubricant eye drops Receives: Drug: Refresh Lubricant Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal staining with fluorescein
National Eye Institute Scoring System: 0=none, 1=mild, 2=moderate, 3=severe
Measured: Change in degree of staining at 6 weeks
Secondary outcomes (6)
Lissamine staining
Lissamine green staining of the conjunctiva
Measured: Change in degree of staining from baseline at 6 weeks
Endothelial cell count
Endothelial cell counts
Measured: Change from baseline at 6 weeks
Intraocular pressure
Pressure measured by tonometry
Measured: Change in pressure from baseline at 6 weeks
Tear volume
Schirmer tear production test
Measured: Change in tear volume from baseline at 6 weeks
Assessment of structure and function of the eye
Change in corrected visual acuity
Measured: Change from baseline at 6 weeks
Assessment of Ocular Surface Disease Index (OSDI)
Subject will compete OSDI questionnaire at baseline and at 6 weeks
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromeStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noveome Biotherapeutics, formerly Stemnion
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- U.S. Navy Bureau of Medicine
- Responsible party
- Sponsor
- Investigators
- David Steed, MD, Study director, Noveome Biotherapeutics, formerly StemnionKathy Kelley, OD, Principal investigator, Price Vision Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02369861
- Sponsor's protocol ID
- ST-05-14
- Status last verified
- May 2019
- First submitted
- 14 Jan 2015
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Masked, Active Placebo-controlled Phase 1 Study of Amnion-derived Cellular Cytokine Solution (ACCS) Eye Drops in the Treatment of Dry Eye
- ClinicalTrials.gov ID
- NCT02369861
- Acronym / sponsor ID
- ST-05-14
- Conditions
- Dry Eye Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Noveome Biotherapeutics, formerly StemnionIndustry (pharma, biotech, devices)
- Collaborators
- U.S. Navy Bureau of Medicine
- Study start
- Mar 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects with moderate-to-severe Dry Eye by symptoms will be screened including history, ophthalmic examination to include the status of their ocular structure and function and evaluation of tear production. Blood will be blood drawn for complete blood count and chemistry panel. They will also have a urinalysis and pregnancy test in women of child-bearing potential.
Subjects will have a two week "run-in" period in which they use artificial tears. If their Dry Eye signs and symptoms do not improve significantly, they will be enrolled and will receive study drug.
Safety evaluation includes assessment of the structure and function of the eyes including retina examination and corrected visual acuity.
Subjects who meet the inclusion and exclusion criteria will be randomly assigned to one of two treatment arms, ST266 or "artificial tears" eye drops. The randomization scheme is 1:1 ST266:artificial tears. Subjects will self-administer their eye drops four times each day.
Subjects will be seen in the office of the ophthalmologist/optometrist at baseline (week zero), one week, three weeks, six weeks and ten weeks. Eye examination will be done at each visit. The baseline eye tests and lab work will be repeated after the treatment phase of the study at the end of week six. Following 6 weeks of treatment, the subjects will be followed for 4 additional weeks.
Detailed description
Subjects with moderate-to-severe Dry Eye judged by symptoms will be screened following signing of informed consent. Screening will involve history and physical examination including ophthalmic examination with dilated fundus exam to assess the status of their ocular structure and function, and evaluation of tear production and damage caused by clinically significant Dry Eye. Blood will be blood drawn for complete blood count, chemistry panel including serum glucose, blood urea nitrogen, electrolytes, creatinine, liver function studies including total and direct bilirubin, alkaline phosphatase, alanine transaminase (ALT), aspartate transaminase (AST), albumin, and total protein. They will also have a urinalysis. Pregnancy test will be performed in women of child-bearing potential.
Subjects will have a two week "run-in" period in which they use artificial tears. Those subjects in whom corneal staining is 2 or more (on a scale of 0-4), Dry Eye symptom score on the OSDI is 25-75 after two weeks of using artificial tears four times per day, and laboratory test results within the accepted ranges will be enrolled and will receive study drug, Those subjects in whom dry eye symptoms improve sufficiently (OSDI drops below 25) and/or corneal staining is reduced from 2 or more to less than 2, or have laboratory test results outside the accepted ranges will not be enrolled.
Safety evaluation includes assessment of the structure and function of the eyes including conjunctival and corneal tissues. Corrected visual acuity will be measured at every visit. Patient comfort will be assessed after administration of the study drug and at every visit. A retina examination will be performed before and after the treatment period. Slit lamp exam including the cornea, conjunctiva, anterior chamber, iris, eye lids and lashes will be performed at every visit. Special testing will include fluorescein staining of the cornea, lissamine green staining of the conjunctiva, endothelial cell analysis, Schirmer tear production, and intraocular pressure measured on all subjects.
Subjects who meet the inclusion and exclusion criteria will be randomly assigned to one of two treatment arms, ST266 or "artificial tears" eye drops. ST266 and artificial tears eye drops will be supplied by Stemnion, and both personnel and subjects will be trained in its use. The treatment will be prepared in a coded container such that the subject and physician are masked as to the treatment. One treatment arm will receive ST266 eye drops in both eyes and the other treatment arm will receive artificial tears eye drops in both eyes. Treatment arms will be assigned by random. The randomization scheme is 1:1 ST266:artificial tears. Subjects will self-administer their eye drops four times each day. Subjects will be asked to keep a study diary of when they place the study medication in their eyes.
Subjects will be seen in the office of the ophthalmologist/optometrist at baseline (week zero), one week, three weeks, six weeks and ten weeks. Eye examination will be done at each visit. Each subject will complete a patient questionnaire on their symptoms of Dry Eye. The baseline eye tests and lab work will be repeated after the treatment phase of the study at the end of week six. Following 6 weeks of treatment, the subjects will be followed for 4 additional weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ST266 | Experimental | Drug: ST266Eye drops |
| Artificial tears | Placebo comparator | Drug: Refresh Lubricant Eye DropsRefresh lubricant eye drops |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects ages 18 years and older.
- Subjects with symptoms and signs of Dry Eye for > four months supported by previous clinical diagnosis or self-reported history.
- Visual acuity corrected 20/40 or better in each eye.
- If wearing contact lenses, subjects must be willing to refrain from wearing the contact lenses during the study (including washout period).
- Score of 25-75 on the Ocular Surface Disorder Index (OSDI) questionnaire.
Key exclusion criteria (13 listed)
- Pregnant or breast feeding.
- Anterior segment disease other than Dry Eye which in the opinion of the investigator would confound the study.
- Macular and neovascular eye diseases
- History of corneal surgery or LASIK (laser in situ keratomileusis) surgery in either eye within the past year.
- Use of cyclosporine, steroid eye drops, serum eye drops, or any other eye medication (except for artificial tears) or experimental drug within the past 30 days.
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 |
|---|---|---|
| ST266Topical ocular application 4 times per day | Drug | ST266 |
| Refresh Lubricant Eye DropsTopical ocular application 4 timer per day | Drug | Artificial tears |
Primary outcome
Corneal staining with fluorescein
Time frame: Change in degree of staining at 6 weeks
National Eye Institute Scoring System: 0=none, 1=mild, 2=moderate, 3=severe
6 secondary outcomes
Lissamine staining
Time frame: Change in degree of staining from baseline at 6 weeks
Endothelial cell count
Time frame: Change from baseline at 6 weeks
Intraocular pressure
Time frame: Change in pressure from baseline at 6 weeks
Tear volume
Time frame: Change in tear volume from baseline at 6 weeks
Assessment of structure and function of the eye
Time frame: Change from baseline at 6 weeks
Assessment of Ocular Surface Disease Index (OSDI)
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
Related trials for Dry Eye Syndrome
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Not yet recruitingPhase 2
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
Dry Eye Disease (DED), Graft-Versus-Host Disease(GVHD)
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.
David Steed, MD study director
Noveome Biotherapeutics, formerly Stemnion
Kathy Kelley, OD principal investigator
Price Vision Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ST266 and Refresh Lubricant Eye Drops in people with Dry Eye Syndrome, run by Noveome Biotherapeutics, formerly Stemnion 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 6 inclusion and 13 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 13 May 2019. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 with fluorescein (time frame: Change in degree of staining at 6 weeks). 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 13 May 2019.