SchizophreniaPhase 1NCT02392468
Study of Systemic and Ocular Safety and Pharmacokinetics of BI 409306 in Patients With Schizophrenia, Alzheimer's Disease, and Healthy Volunteers
A Phase 1 study testing BI 409306 25 mg and BI 409306 50 mg in people with Schizophrenia and Alzheimer Disease, run by Boehringer Ingelheim at 3 sites in United States.
Trial summary
Single site, parallel-group, double-blind trial of low or high dose of BI 409306 to evaluate the ocular and systemic safety and pharmacokinetics during 14 day treatment period in patients with schizophrenia, Alzheimer's disease, or age comparable healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Alzheimer Disease
- What is being tested?
- BI 409306 25 mg and BI 409306 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Apr 2015to 10 Aug 2017
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Schizophrenia group:
- Patients with established diagnoses of schizophrenia (per Diagnostic and Statistic Manual of Mental Disorder, version V) with the all of the following clinical features:
- Clinically stable and are in the residual (non-acute) phase of their illness for at least 8 weeks prior to randomisation
- Current antipsychotic and concomitant psychotropic medications must meet the criteria below:
- Maintained on current atypical (second generation) antipsychotic medications (in any approved dosage form) other than Clozapine and on current dose for at least 8 weeks prior to randomisation, and/or
- Maintained on current typical (first generation) antipsychotic medications and on current dose for at least 6 months, optionally combined with anticholinergics if treated with a stable dose for at least 6 months prior to randomisation, and/or
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- Maintained on current concomitant psychotropic medications other than anticholinergics, antiepileptics and lithium, and on current dose for at least 8 weeks prior to randomisation. Antiepileptics and lithium are allowed if initiated at least 6 months prior to randomisation.
- Have no more than a moderate severity rating on hallucinations and delusions (Positive and Negative Syndrome Scale (PANSS), positive syndrome Hallucinatory Behavior item score <= 4 and Delusions item score <= 4)
- Have no more than a moderate severity rating on positive formal thought disorder (PANSS, positive syndrome Conceptual Disorganization item score <= 4)
- Have a minimal level of extrapyramidal symptoms (Simpson-Angus Scale total score < 6) and depressive symptoms (PANSS, general psychopathology syndrome Depression item score <= 4)
- Male or female patients age 18 to 55 years.
- Alzheimer's Disease group:
- Patients with diagnosis of mild Alzheimer's Dementia based on DSM-V and in accordance with the recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease.
- Mini-Mental State Examination (MMSE) score of 18-26.
- Male or female patients age 55 to 85 years, who have not been taking acetyl cholinesterase inhibitors (donepezil, galantamine, rivastigmine) and/or memantine for at least 3 months or on stable dose of acetyl cholinesterase inhibitors (donepezil, galantamine, rivastigmine) and/or memantine at least 3 months before randomization.Patients older than 85 years may be included based on an acceptable general health status, (e.g. concomitant diseases, physical capability to follow the required study procedures [visits etc.]) per investigators judgement.
- Availability of a pre-existing cranial computer tomography (CCT) or magnetic resonance imaging (MRI) scan of the brain (initiation of radiological imaging is not required) not older than one year prior to screening; if not available, a CCT must be performed at screening. Results of radiological brain imaging must be compatible with Diagnosis of Alzheimer's Disease and exclusion of relevant signs indicative of potential vascular dementia (see also exclusion criteria).
- If needed, a caregiver may be present during site activities.
- Age-comparable male or female healthy volunteers age 18 to 85 years. Healthy volunteers older than 85 years may be included based on an acceptable general health status, (e.g. concomitant diseases, physical capability to follow the required study procedures [visits etc.]) per investigators judgement:
- After 10 patients with schizophrenia (as described above) are entered into the study, the median age of the group will be computed. Five healthy volunteers at or below the median age but greater than 18 years old and five healthy volunteers above the median but less than 55 will be entered into the study.
- Similarly, after 10 patients with AD are entered, the median age will be computed. Five healthy volunteers at or below the median age but greater than 55 years old and five healthy volunteers above the median but less than 85 will be entered into the study.
- Subjects must exhibit reliability and physiologic capability to comply with all protocol procedures.
- Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice and the local legislation. If the patient needs a legal representative, then this legal representative must give written informed consent as well.
Who cannot join
- Presence of active ocular conditions with or without visual impairment due to any causes (e.g. cataract, chorioretinal macular lesion, amblyopia, active diabetic retinopathy, uncontrolled glaucoma, active inflammation or infection, etc.) in one eye or both eyes at the screening phase.
- Planned ocular treatment (e.g. intravitreal antivascular growth factor, corticosteroids) or surgery during the study period.
- Current or planned use of ocular or systemic corticosteroids.
- Current or planned use of medications known to be toxic to the retina, lens, optic nerve
- Subjects treated with more than two antipsychotic medications (including more than two dosage forms).
- Dementia in Alzheimers Disease patients, secondary to other disorders (based on clinical data and/or current laboratory findings and/or on a pre-existing cranial MRI or CCT).
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- Neurological disease (other than Dementia of Alzheimer Type such as: Lewy body dementia - primary diagnosis, Huntington's disease, Parkinson's Disease encephalitis, epilepsy, vascular or multi-infarct dementia, stroke, congenital mental deficiency, or multiple sclerosis), or mental retardation.
- Subjects needing to take long-acting hypnotics or anxiolytic (i.e. Diazepam).
- For AD patients, the following drugs are prohibited for 3 months prior to randomization and for the duration of the trial:
- tricyclic antidepressants,
- antidepressants that are monoamine oxidase inhibitors,
- neuroleptics with moderate or greater anticholinergic potency (e.g., chlorpromazine, fluphenazine, loxapine, perphenazine, thioridazine),
- anticholinergic medications.
- Intake of St. John's wort, Carbamazepine and extracts from Ginko as they are relevant CYP2C19 inducers.
- Substantial concomitant cerebrovascular disease (defined by a history of a stroke/intracranial haemorrhagia temporally related to the onset of worsening of cognitive impairment).
- Any suicidal ideation of type 4 or 5 in the Columbia Suicidal Severity Rating Scale (C-SSRS) in the past 3 months.
- Any suicidal behavior in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior).
- History or diagnosis of symptomatic and unstable/uncontrolled gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, haematological or hormonal disorders.
- For female subjects:
- --Pre-menopausal women (last menstruation <=1 year prior to informed consent) who:
- are nursing or pregnant or
- are of child-bearing potential and are not practicing an acceptable method of birth control
- For male subjects: Men who are able to father a child, unwilling to be abstinent or use adequate contraception.
- Known history, or new diagnosis of HIV infection.
- Significant renal disease (CLCR < 30 mL/min).
- Bodyweight < 50 kg.
- Indication of liver disease.
- History of neurologic (e.g. stroke, seizure without a clear and resolved etiology, concussion accompanying loss of consciousness) or psychiatric condition.
- History of malignancy within the last 5 years, except for basal cell carcinoma.
- Planned elective surgery requiring general anaesthesia, or hospitalisation during the study period.
- Significant history of drug dependence
- Clinically significant uncompensated hearing loss. Use of hearing aids is not allowed.
- Further exclusion criteria apply.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Community Clinical Research, Inc.
Austin, Texas, 78754
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, 07724
University of California San Diego
La Jolla, California, 92037
About this study
Official title: Randomised, Parallel-group, Double-blind Study of Systemic and Ocular Safety and Pharmacokinetics of BI 409306 in Patients With Schizophrenia, Alzheimer's Disease, and Age-comparable Healthy Volunteers
Single site, parallel-group, double-blind trial of low or high dose of BI 409306 to evaluate the ocular and systemic safety and pharmacokinetics during 14 day treatment period in patients with schizophrenia, Alzheimer's disease, or age comparable healthy volunteers.
- Conditions
- Schizophrenia, Alzheimer Disease
- Being tested
- Placebo matching BI 409306 25 mg, Placebo matching BI 409306 50 mg, BI 409306 25 mg, BI 409306 50 mg
- Medical subject headings
- Schizophrenia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo matching BI 409306 25 mgDrug
Film-coated tablet
Placebo matching BI 409306 50 mgDrug
Film-coated tablet
BI 409306 25 mgDrug
Film-coated tablet
BI 409306 50 mgDrug
Film-coated tablet
| Study group | Role | What they receive |
|---|---|---|
| BI 409306 25 milligram (mg) - Alzheimer patients | Experimental | Alzheimer patients received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days. Receives: Drug: Placebo matching BI 409306 50 mg; Drug: BI 409306 25 mg |
| BI 409306 100 mg - Alzheimer patients | Experimental | Alzheimer patients received once daily (QD) orally 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet for 14 days. Receives: Drug: Placebo matching BI 409306 25 mg; Drug: BI 409306 50 mg |
| BI 409306 25 mg - Schizophrenia patients | Experimental | Schizophrenia patients (cognitive impairment associated with schizophrenia) received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days. Receives: Drug: Placebo matching BI 409306 50 mg; Drug: BI 409306 25 mg |
| BI 409306 100 mg - Schizophrenia patients | Experimental | Schizophrenia patients (cognitive impairment associated with schizophrenia) received once daily (QD) orally 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet for 14 days. Receives: Drug: Placebo matching BI 409306 25 mg; Drug: BI 409306 50 mg |
| BI 409306 25 mg - Healthy volunteers | Active comparator | Age-comparable healthy volunteers received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days. Receives: Drug: Placebo matching BI 409306 50 mg; Drug: BI 409306 25 mg |
| BI 409306 100 mg - Healthy volunteers | Active comparator | Age-comparable healthy volunteers received once daily (QD) 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet orally for 14 days. Receives: Drug: Placebo matching BI 409306 25 mg; Drug: BI 409306 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Participants With Adverse Events (AEs), Coded to the Medical Dictionary for Regulatory Activities - System Organ Class Eye Disorders, as Determined by the Investigator at the End of Trial
The percentage of participants with Adverse Events (AEs), coded to the Medical Dictionary for Regulatory Activities (MedDRA) - System Organ Class (SOC) 'Eye disorders', as determined by the investigator at the End of Trial (EOT) is reported.
Percentages were rounded to one decimal place.
Measured: From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
Secondary outcomes (3)
The Percentage of Participants With Drug-related AEs as Determined by the Investigator at EOT
The percentage of participants with drug-related adverse events (AEs) as determined by the investigator at end of trial (EOT) is reported.
Percentages were rounded to one decimal place.
Measured: From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
Maximum Measured Concentration of BI 409306 in Plasma at Steady-state (Cmax,ss)
Maximum measured concentration of BI 409306 in plasma at steady-state (Cmax,ss) is reported.
Measured: Pharmacokinetic blood samples were taken at 2:00 (hours: minutes) before and 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 4:00, 6:00 (hours: minutes) after drug administration on day 14.
Time From Dosing to Maximum Measured Concentration of BI 409306 in Plasma at Steady-state (Tmax,ss)
Time from dosing to maximum measured concentration of BI 409306 in plasma at steady-state (tmax,ss) is reported.
Measured: Pharmacokinetic blood samples were taken at 2:00 (hours: minutes) before and 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 4:00, 6:00 (hours: minutes) after drug administration on day 14.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study start15 Apr 2015
- Primary completion3 Aug 2017
- Study completion10 Aug 2017
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 SchizophreniaStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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
- Double blind
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392468
- Sponsor's protocol ID
- 1289.27
- Status last verified
- Apr 2024
- First submitted
- 17 Mar 2015
- Last updated
- 19 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Parallel-group, Double-blind Study of Systemic and Ocular Safety and Pharmacokinetics of BI 409306 in Patients With Schizophrenia, Alzheimer's Disease, and Age-comparable Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02392468
- Acronym / sponsor ID
- 1289.27
- Conditions
- Schizophrenia, Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2015 (actual)
- Primary completion
- 3 Aug 2017 (actual)
- Study completion
- 10 Aug 2017 (actual)
- First posted
- 19 Mar 2015 (estimated)
- Results
- Posted 19 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single site, parallel-group, double-blind trial of low or high dose of BI 409306 to evaluate the ocular and systemic safety and pharmacokinetics during 14 day treatment period in patients with schizophrenia, Alzheimer's disease, or age comparable healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| BI 409306 25 milligram (mg) - Alzheimer patients | Experimental | Drug: Placebo matching BI 409306 50 mg, Drug: BI 409306 25 mgAlzheimer patients received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days. |
| BI 409306 100 mg - Alzheimer patients | Experimental | Drug: Placebo matching BI 409306 25 mg, Drug: BI 409306 50 mgAlzheimer patients received once daily (QD) orally 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet for 14 days. |
| BI 409306 25 mg - Schizophrenia patients | Experimental | Drug: Placebo matching BI 409306 50 mg, Drug: BI 409306 25 mgSchizophrenia patients (cognitive impairment associated with schizophrenia) received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days. |
| BI 409306 100 mg - Schizophrenia patients | Experimental | Drug: Placebo matching BI 409306 25 mg, Drug: BI 409306 50 mgSchizophrenia patients (cognitive impairment associated with schizophrenia) received once daily (QD) orally 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet for 14 days. |
| BI 409306 25 mg - Healthy volunteers | Active comparator | Drug: Placebo matching BI 409306 50 mg, Drug: BI 409306 25 mgAge-comparable healthy volunteers received once daily (QD) orally one tablet of 25 mg of BI 409306 and two 50 mg matching placebo tablets for 14 days. |
| BI 409306 100 mg - Healthy volunteers | Active comparator | Drug: Placebo matching BI 409306 25 mg, Drug: BI 409306 50 mgAge-comparable healthy volunteers received once daily (QD) 100 mg of BI 409306 (two 50 mg active tablets) and one 25 mg matching placebo tablet orally for 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Schizophrenia group:
- Alzheimer's Disease group:
- Age-comparable male or female healthy volunteers age 18 to 85 years. Healthy volunteers older than 85 years may be included based on an acceptable general health status, (e.g. concomitant diseases, physical capability to follow the required study procedures [visits etc.]) per investigators judgement:
- Subjects must exhibit reliability and physiologic capability to comply with all protocol procedures.
- Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice and the local legislation. If the patient needs a legal representative, then this legal representative must give written informed consent as well.
Key exclusion criteria (33 listed)
- Presence of active ocular conditions with or without visual impairment due to any causes (e.g. cataract, chorioretinal macular lesion, amblyopia, active diabetic retinopathy, uncontrolled glaucoma, active inflammation or infection, etc.) in one eye or both eyes at the screening phase.
- Planned ocular treatment (e.g. intravitreal antivascular growth factor, corticosteroids) or surgery during the study period.
- Current or planned use of ocular or systemic corticosteroids.
- Current or planned use of medications known to be toxic to the retina, lens, optic nerve
- Subjects treated with more than two antipsychotic medications (including more than two dosage forms).
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 |
|---|---|---|
| Placebo matching BI 409306 25 mgFilm-coated tablet | Drug | BI 409306 100 mg - Alzheimer patients, BI 409306 100 mg - Healthy volunteers, BI 409306 100 mg - Schizophrenia patients |
| Placebo matching BI 409306 50 mgFilm-coated tablet | Drug | BI 409306 25 mg - Healthy volunteers, BI 409306 25 mg - Schizophrenia patients, BI 409306 25 milligram (mg) - Alzheimer patients |
| BI 409306 25 mgFilm-coated tablet | Drug | BI 409306 25 mg - Healthy volunteers, BI 409306 25 mg - Schizophrenia patients, BI 409306 25 milligram (mg) - Alzheimer patients |
| BI 409306 50 mgFilm-coated tablet | Drug | BI 409306 100 mg - Alzheimer patients, BI 409306 100 mg - Healthy volunteers, BI 409306 100 mg - Schizophrenia patients |
Primary outcome
The Percentage of Participants With Adverse Events (AEs), Coded to the Medical Dictionary for Regulatory Activities - System Organ Class Eye Disorders, as Determined by the Investigator at the End of Trial
Time frame: From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
The percentage of participants with Adverse Events (AEs), coded to the Medical Dictionary for Regulatory Activities (MedDRA) - System Organ Class (SOC) 'Eye disorders', as determined by the investigator at the End of Trial (EOT) is reported. Percentages were rounded to one decimal place.
3 secondary outcomes
The Percentage of Participants With Drug-related AEs as Determined by the Investigator at EOT
Time frame: From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.
Maximum Measured Concentration of BI 409306 in Plasma at Steady-state (Cmax,ss)
Time frame: Pharmacokinetic blood samples were taken at 2:00 (hours: minutes) before and 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 4:00, 6:00 (hours: minutes) after drug administration on day 14.
Time From Dosing to Maximum Measured Concentration of BI 409306 in Plasma at Steady-state (Tmax,ss)
Time frame: Pharmacokinetic blood samples were taken at 2:00 (hours: minutes) before and 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 4:00, 6:00 (hours: minutes) after drug administration on day 14.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 409306 25 mg and BI 409306 50 mg in people with Schizophrenia and Alzheimer Disease, run by Boehringer Ingelheim at 3 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 22 inclusion and 33 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 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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?
Yes. Results are posted in the registry (first posted 19 Apr 2024). 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?
The Percentage of Participants With Adverse Events (AEs), Coded to the Medical Dictionary for Regulatory Activities - System Organ Class Eye Disorders, as Determined by the Investigator at the End of Trial (time frame: From the first dose of trial medication until 7 days after last in-take of trial medication, 21 days.). 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 19 Apr 2024; AzTrials last refreshed its copy on 8 Nov 2026.