Dry EyePhase 1/2NCT03414645
Topical Fibrinogen-Depleted Human Platelet Lysate in Patients With Dry Eye Secondary to Graft vs. Host Disease
A Phase 1/2 study testing CAM-101 10% and CAM-101 30% in people with Dry Eye and Graft-versus-host-disease, run by Cambium Bio Limited at 6 sites in United States.
Trial summary
The purpose of this Phase 1/2 study is to compare the safety and tolerability of four times a day (QID) dosing of a non-preserved topical ocular drop formulation of 10 vol/vol % and 30 vol/vol % of FD hPL to vehicle control eye drops in patients with Dry Eye Disease (DED) secondary to Graft vs. Host Disease (GvHD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye, Graft-versus-host-disease, Ocular Discomfort
- What is being tested?
- CAM-101 10% and CAM-101 30%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 May 2018to 20 Feb 2020
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients, of age 18 years (inclusive) or older at the time of signing the ICF;
- Diagnosis of DED secondary to GvHD following allogeneic hematopoietic stem cell transplantation as determined by medical history
- For females:
- Be of non-child-bearing potential. Surgically sterilized (e.g., hysterectomy or bilateral oophorectomy) for at least 6 months prior to screening or postmenopausal (postmenopausal women must have no menstrual bleeding for at least 1 year prior to screening) and menopause will be confirmed by a plasma FSH level of >40 IU/L) or
- Women of childbearing potential must be non-lactating and agree to use a highly effective acceptable form of birth control (e.g., established hormonal birth control plus a barrier method, double barrier method: intrauterine device plus condom or spermicidal gel plus condom) from 21 days prior to dosing until 7 days after dosing, and
- Women with a negative pregnancy test (β-hCG assay) in urine at screening and Day 1 predose;
Show all 11Show fewer
- Schirmer tear test with anesthesia <7 mm/5 min in at least one eye during screening;
- Willingness and and ability to undergo, and return for, all scheduled study-related visits through Follow-up;
- Willingness and and ability to provide written Informed Consent consistent with privacy language as per national regulations (e.g., HIPAA authorization) and which signature may be obtained from the patient or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication);
- Willingness to communicate with the Investigator and site staff and comply with all study procedures and requirements;
- Agreement not to participate in another interventional study while participating in this study.
Who cannot join
- Any abnormal lid anatomy or blinking function in either eye;
- Any history of other ocular disease requiring topical ocular treatment other than artificial tears and/or Restasis® (cyclosporine ophthalmic emulsion; Allergan Irvine, CA) or Xiidra® (lifitegrast, Shire, Lexington, MA). Patients currently using Restasis® or Xiidra® for conditions other than DED (e.g., allergies);
- Previous intraocular or ocular laser surgery within the past 3 months or any refractive surgery procedure within the past 6 months of the screening visit in either eye;
- Any relevant ocular anomaly interfering with the ocular surface, including active ocular herpes simplex infection, recurrent corneal erosion, symptomatic epithelial basement membrane dystrophy, mucus fishing syndrome, giant papillary conjunctivitis, post-radiation keratitis, Stevens-Johnson syndrome, corneal ulcer, abnormalities of the nasolachrymal drainage system, chemical injury, destruction of the conjunctival goblet cells or scaring, diagnosed significant anterior blepharitis and/or progressive pterygium, or any other additional condition(s) associated with or causing dry eye;
- Presence or history of any ocular disorder or condition, including ocular surgery (including palpebral and cataract surgery, trauma), infection (viral, bacterial, fungal), disease or inflammation not associated with dry eye unless disorder or disease is:
- Stable for at least 3 months before the Screening Visit; and
Show all 22Show fewer
- As determined by the Investigator not likely to impact or possibly interfere with the interpretation of study results.
- History of ocular allergy (including seasonal conjunctivitis) or chronic conjunctivitis other than dry eye;
- Known hypersensitivity to one of the components of the study or procedural medications (e.g., fluorescein, lissamine green, Refresh Plus®);
- Inability to refrain from contact lens wear during the study, including the 2 week Run-in period;
- Anticipated temporary or permanent need for punctal plugs during the study, except if punctal plugs have been in place for at least 2 weeks prior to Screening, in which case the plugs are allowed to remain in place during the study; if plugs should fall out during the course of the study, the instance will be recorded and the plug(s) can be replaced;
- Ocular or clinically significant systemic disease (e.g., diabetes with glycemia out of range, thyroid malfunction, uncontrolled autoimmune disease) or condition(s) not stabilized within 1 month (30 days) before Screening or a condition judged by the Investigator to be incompatible or interferes with the study results;
- Inability or unwillingness to discontinue use of autologous or platelet rich plasma eye drops during the 2 week washout period and the duration of the study;
- Anticipated change in the use or dose of Restasis®, Xiidra®, or artificial tears within 14 days before Screening or during the study. If currently taking Restasis®, Xiidra®, or artificial tears, treatment(s) for DED can continue throughout the study without a change in dose. If currently using Restasis® or Xiidra® for conditions other than DED, then patient will be excluded from study. If not currently taking Restasis®, Xiidra® or artificial tears, these drugs cannot begin during the study;
- Anticipated change in the patient's use of or dosage of systemic medications that could affect tear function (e.g., antihistamines, tricyclic antidepressants, anxiolytics, antimuscarinics, beta-blocking agents, phenothiazines, tacrolimus, sirolimus, etc.) during the study. If currently taking any of these drugs, treatment(s) can continue throughout the study without a change in dose;
- Pregnancy or breast feeding at the time of study entry;
- History of clinically significant drug or food allergy;
- Positive HIV, hepatitis B or C viral test at screening;
- History, as judged by the Investigator, of drug or alcohol abuse (i.e., alcohol consumption >2 drinks/day over the last 3 months prior to screening); drug abuse is any use of illegal drugs or prescription-drug over usage or addiction;
- Taken any investigational medication and/or participated in any clinical studies within 30 days of screening;
- Any patient who, in the judgment of the Investigator, may not be able to cooperate fully with the study staff, may have difficulty following some study requirements, or is otherwise not qualified for the study;
- Any patient who is directly involved in the conduct of the protocol.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Michigan - Kellogg Clinical Research Center
Ann Arbor, Michigan, 48105
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
Duke University Eye Center
Durham, North Carolina, 27710
University of Minnesota
Minneapolis, Minnesota, 55455
Byers Eye Institute of Stanford University
Palo Alto, California, 94303
Oregon Health Sciences University - Casey Eye Institute
Portland, Oregon, 97239
About this study
Official title: Randomized Multicenter Double-Masked Placebo-Controlled Parallel Phase I/II Study to Determine the Safety and Exploratory Efficacy of Topical Fibrinogen Depleted Human Platelet Lysate in Patients With Dry Eye Secondary to Graft vs Host Disease
The purpose of this Phase 1/2 study is to compare the safety and tolerability of four times a day (QID) dosing of a non-preserved topical ocular drop formulation of 10 vol/vol % and 30 vol/vol % of FD hPL to vehicle control eye drops in patients with Dry Eye Disease (DED) secondary to Graft vs. Host Disease (GvHD).
Read the detailed description
For patients who do not find relief from other modes of therapy, autologous serum tears have been used as an alternative therapy since the mid-1980s. Limitations such as the need for periodic blood draws, the lack of standardization in the preparation of AST and platelet-enriched plasma tears, the unknown shelf life of AST preparations, the use of non-preserved multi-dose packaging and the practical difficulties patients face in storing these products frozen or refrigerated have hindered their widespread use for treating GvHD and other forms of severe tear deficiency.
To address these shortcomings, Cambium Medical Technologies, LLC has developed a proprietary method of standardizing and manufacturing a fibrinogen-depleted standardized platelet lysate using pooled human platelet lysates (phPL) collected from qualified healthy donors (CAM-101). Because Cambium's proprietary manufacturing process depletes pooled human platelet lysates of fibrinogen (the key clotting protein in platelets), the remaining product contains enriched levels of several key nutritive and regenerative components than are normally found in non-standardized AST as well as healthy tear film.
Given the multi-factorial nature of DED, the enriched levels of numerous key nutritive components in CAM-101 may well prove to be superior to artificial tears and certain single active ingredient products which treat only one cause or contributor of dry eye (e.g., inflammation) and other forms of tear deficiency.
- Conditions
- Dry Eye, Graft-versus-host-disease, Ocular Discomfort
- Being tested
- CAM-101 10%, Vehicle Control, CAM-101 30%
- 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.
CAM-101 10%Biological
Also called FD hPL 10% vol/vol
fibrinogen-depleted human platelet lysate
Vehicle ControlBiological
PlasmaLyte-A, vehicle control, a preservative-free ophthalmic drop
CAM-101 30%Biological
Also called FD hPL 30% vol/vol
fibrinogen-depleted human platelet lysate
| Study group | Role | What they receive |
|---|---|---|
| CAM-101 10% | Experimental | FD hPL 10 vol/vol % Receives: Biological: CAM-101 10% |
| CAM-101 30% | Experimental | FD hPL 30 vol/vol % Receives: Biological: CAM-101 30% |
| Vehicle Control | Placebo comparator | PlasmaLyte-A, vehicle control, a preservative-free ophthalmic drop Receives: Biological: Vehicle Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Ocular Treatment-related Adverse Events as Assessed by CTCAE v4.0
To evaluate the safety and tolerability of two concentrations of CAM-101 (FD hPL 10 vol/vol % and 30 vol/vol %) topical ophthalmic solution in patients with dry eye disease (DED) secondary to graft versus host disease (GvHD) after 6 weeks (42 days) of treatment.
The primary outcome measure:
Percentage of patients in each dose group with ocular adverse events at Day 42
Measured: 42 Days
Number of Participants With Systemic Treatment-related Adverse Events as Assessed by CTCAE v4.0
Number of participants with systemic treatment-related adverse events as assessed by CTCAE v4.0 To evaluate the safety and tolerability of two concentrations of CAM-101 (FD hPL 10 vol/vol % and 30 vol/vol %) topical ophthalmic solution in patients with dry eye disease (DED) secondary to graft versus host disease (GvHD) after 6 weeks (42 days) of treatment.
The primary outcome measure:
Percentage of patients in each dose group with systemic adverse event at Day 42
Measured: 42 Days
Number of Participants With Treatment-related Adverse Events as Assessed Change From Normal to Abnormal With Clinical Significance in Any Ocular Examination
To evaluate the safety and tolerability of two concentrations of CAM-101 (FD hPL 10 vol/vol % and 30 vol/vol %) topical ophthalmic solution in patients with dry eye disease (DED) secondary to graft versus host disease (GvHD) after 6 weeks (42 days) of treatment.
The primary outcome measure:
The percentage of patients in each dose group that show a change from Normal to Abnormal with clinical significance in any ocular examination assessment at Day 42
Measured: 42 Days
Secondary outcomes (2)
Efficacy as Measured by Ocular Surface Disease Index (OSDI)
The OSDI is a 12-item validated questionnaire used to assess the severity of dry eye disease symptoms and their impact on vision-related function. The questionnaire comprises three subscales: ocular symptoms, vision-related function, and environmental triggers. Each item is scored on a 5-point scale (0 = none of the time; 4 = all of the time). The total OSDI score is calculated using the following formula: OSDI score = (sum of score for all questions answered × 25) ÷ number of questions answered; Scores range from 0 to 100; higher scores indicate greater ocular surface disease severity and disability (0-12: normal; 13-22: mild disease; 23-32: moderate disease; >33: severe disease).
Measured: 42 Days
Efficacy as Measured by Ocular Discomfort Using the 100 Point Visual Analogue Scale (VAS) Scores
To evaluate the preliminary efficacy of two concentrations of FD hPL (10 vol/vol % and 30 vol/vol %) to each other and to a vehicle control in the treatment of patients with DED secondary to GvHD as the result of allogeneic stem cell transplantation as measured by ocular discomfort using the 100 point visual analogue scale (VAS) scores
Change from baseline in ocular discomfort score as measured with VAS on Day 42VAS Patients will be asked questions about their current ocular discomfort by indicating from 0 (no discomfort) to 100 (maximal discomfort)
Measured: 42 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start1 May 2018
- Primary completion12 Dec 2019
- Study completion20 Feb 2020
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambium Bio Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts Eye and Ear Infirmary, Oregon Health and Science University, University of Michigan, Duke University, Stanford University, University of Minnesota
- Responsible party
- Sponsor
- Investigators
- Edmund K Waller, MD PhD, Study director, Cambium Bio Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414645
- Sponsor's protocol ID
- CAM-101
- Status last verified
- Jun 2026
- First submitted
- 8 Jan 2018
- Last updated
- 12 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multicenter Double-Masked Placebo-Controlled Parallel Phase I/II Study to Determine the Safety and Exploratory Efficacy of Topical Fibrinogen Depleted Human Platelet Lysate in Patients With Dry Eye Secondary to Graft vs Host Disease
- ClinicalTrials.gov ID
- NCT03414645
- Acronym / sponsor ID
- CAM-101
- Conditions
- Dry Eye, Graft-versus-host-disease, Ocular Discomfort
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Cambium Bio LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Massachusetts Eye and Ear Infirmary, Oregon Health and Science University, University of Michigan, Duke University, Stanford University, University of Minnesota
- Study start
- 1 May 2018 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 30 Jan 2018 (actual)
- Results
- Posted 12 Jun 2026
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 Phase 1/2 study is to compare the safety and tolerability of four times a day (QID) dosing of a non-preserved topical ocular drop formulation of 10 vol/vol % and 30 vol/vol % of FD hPL to vehicle control eye drops in patients with Dry Eye Disease (DED) secondary to Graft vs. Host Disease (GvHD).
Detailed description
For patients who do not find relief from other modes of therapy, autologous serum tears have been used as an alternative therapy since the mid-1980s. Limitations such as the need for periodic blood draws, the lack of standardization in the preparation of AST and platelet-enriched plasma tears, the unknown shelf life of AST preparations, the use of non-preserved multi-dose packaging and the practical difficulties patients face in storing these products frozen or refrigerated have hindered their widespread use for treating GvHD and other forms of severe tear deficiency.
To address these shortcomings, Cambium Medical Technologies, LLC has developed a proprietary method of standardizing and manufacturing a fibrinogen-depleted standardized platelet lysate using pooled human platelet lysates (phPL) collected from qualified healthy donors (CAM-101). Because Cambium's proprietary manufacturing process depletes pooled human platelet lysates of fibrinogen (the key clotting protein in platelets), the remaining product contains enriched levels of several key nutritive and regenerative components than are normally found in non-standardized AST as well as healthy tear film.
Given the multi-factorial nature of DED, the enriched levels of numerous key nutritive components in CAM-101 may well prove to be superior to artificial tears and certain single active ingredient products which treat only one cause or contributor of dry eye (e.g., inflammation) and other forms of tear deficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CAM-101 10% | Experimental | Biological: CAM-101 10%FD hPL 10 vol/vol % |
| CAM-101 30% | Experimental | Biological: CAM-101 30%FD hPL 30 vol/vol % |
| Vehicle Control | Placebo comparator | Biological: Vehicle ControlPlasmaLyte-A, vehicle control, a preservative-free ophthalmic drop |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female patients, of age 18 years (inclusive) or older at the time of signing the ICF;
- Diagnosis of DED secondary to GvHD following allogeneic hematopoietic stem cell transplantation as determined by medical history
- For females:
- Schirmer tear test with anesthesia <7 mm/5 min in at least one eye during screening;
- Willingness and and ability to undergo, and return for, all scheduled study-related visits through Follow-up;
Key exclusion criteria (22 listed)
- Any abnormal lid anatomy or blinking function in either eye;
- Any history of other ocular disease requiring topical ocular treatment other than artificial tears and/or Restasis® (cyclosporine ophthalmic emulsion; Allergan Irvine, CA) or Xiidra® (lifitegrast, Shire, Lexington, MA). Patients currently using Restasis® or Xiidra® for conditions other than DED (e.g., allergies);
- Previous intraocular or ocular laser surgery within the past 3 months or any refractive surgery procedure within the past 6 months of the screening visit in either eye;
- Any relevant ocular anomaly interfering with the ocular surface, including active ocular herpes simplex infection, recurrent corneal erosion, symptomatic epithelial basement membrane dystrophy, mucus fishing syndrome, giant papillary conjunctivitis, post-radiation keratitis, Stevens-Johnson syndrome, corneal ulcer, abnormalities of the nasolachrymal drainage system, chemical injury, destruction of the conjunctival goblet cells or scaring, diagnosed significant anterior blepharitis and/or progressive pterygium, or any other additional condition(s) associated with or causing dry eye;
- Presence or history of any ocular disorder or condition, including ocular surgery (including palpebral and cataract surgery, trauma), infection (viral, bacterial, fungal), disease or inflammation not associated with dry eye unless disorder or disease is:
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 |
|---|---|---|
| CAM-101 10%Also: FD hPL 10% vol/volfibrinogen-depleted human platelet lysate | Biological | CAM-101 10% |
| Vehicle ControlPlasmaLyte-A, vehicle control, a preservative-free ophthalmic drop | Biological | Vehicle Control |
| CAM-101 30%Also: FD hPL 30% vol/volfibrinogen-depleted human platelet lysate | Biological | CAM-101 30% |
Primary outcome
Number of Participants With Ocular Treatment-related Adverse Events as Assessed by CTCAE v4.0
Time frame: 42 Days
To evaluate the safety and tolerability of two concentrations of CAM-101 (FD hPL 10 vol/vol % and 30 vol/vol %) topical ophthalmic solution in patients with dry eye disease (DED) secondary to graft versus host disease (GvHD) after 6 weeks (42 days) of treatment. The primary outcome measure: Percentage of patients in each dose group with ocular adverse events at Day 42
Number of Participants With Systemic Treatment-related Adverse Events as Assessed by CTCAE v4.0
Time frame: 42 Days
Number of participants with systemic treatment-related adverse events as assessed by CTCAE v4.0 To evaluate the safety and tolerability of two concentrations of CAM-101 (FD hPL 10 vol/vol % and 30 vol/vol %) topical ophthalmic solution in patients with dry eye disease (DED) secondary to graft versus host disease (GvHD) after 6 weeks (42 days) of treatment. The primary outcome measure: Percentage of patients in each dose group with systemic adverse event at Day 42
Number of Participants With Treatment-related Adverse Events as Assessed Change From Normal to Abnormal With Clinical Significance in Any Ocular Examination
Time frame: 42 Days
To evaluate the safety and tolerability of two concentrations of CAM-101 (FD hPL 10 vol/vol % and 30 vol/vol %) topical ophthalmic solution in patients with dry eye disease (DED) secondary to graft versus host disease (GvHD) after 6 weeks (42 days) of treatment. The primary outcome measure: The percentage of patients in each dose group that show a change from Normal to Abnormal with clinical significance in any ocular examination assessment at Day 42
2 secondary outcomes
Efficacy as Measured by Ocular Surface Disease Index (OSDI)
Time frame: 42 Days
Efficacy as Measured by Ocular Discomfort Using the 100 Point Visual Analogue Scale (VAS) Scores
Time frame: 42 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Dry Eye
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
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
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.
Edmund K Waller, MD PhD study director
Cambium Bio Limited
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CAM-101 10% and CAM-101 30% in people with Dry Eye and Graft-versus-host-disease, run by Cambium Bio Limited at 6 sites 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 11 inclusion and 22 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 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 combined 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.
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 12 Jun 2026). 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?
Number of Participants With Ocular Treatment-related Adverse Events as Assessed by CTCAE v4.0 (time frame: 42 Days). 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 12 Jun 2026.