Posner Schlossman SyndromeNCT04590183
The Effectiveness and Safety of FK-506 for the Treatment of Posner-Schlossman Syndrome
A study testing FK-506 (Drug) and Prednisolone Acetate 1% Oph Susp in people with Posner Schlossman Syndrome, run by Peking University at 1 site in China.
Trial summary
To evaluate the effectiveness and safety of tacrolimus eye drops (FK-506) in the treatment of Posner-Schlossman Syndrome. It is expected to collect 30 patients with PSS who are in the Ophthalmology Department of Peking University Third Hospital. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Posner Schlossman Syndrome
- What is being tested?
- FK-506 (Drug) and Prednisolone Acetate 1% Oph Susp
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to Sep 2021
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of PSS Must be able to communicate with doctor and understand this study
Who cannot join
- Fuchs syndrome
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hosipital
Beijing, Beijing Municipality, 100191
Pro. Zhang, PHD, MD, 0086-186-0103-1059, zhangc1@yahoo.com
About this study
Official title: Peking University Third Hospital Medical Science Research Ethics Committee
To evaluate the effectiveness and safety of tacrolimus eye drops (FK-506) in the treatment of Posner-Schlossman Syndrome. It is expected to collect 30 patients with PSS who are in the Ophthalmology Department of Peking University Third Hospital. The included PSS patients were divided into experimental group and control group using simple randomization method. Among them, the experimental group was treated with FK-506 twice a day, and the control group was treated with prednisolone acetate ophthalmic suspension 1% 4 times a day.
For all PSS patients whose intraocular pressure is higher than 30mmHg, also add brinzolamide eye drops 3 times a day. Best corrected visual acuity, Goldmann intraocular pressure, anterior section photographs, corneal endothelial cells，corneal confocal microscope, Heidelberg retinal nerve analysis, Octopus visual field were examined on baseline and 1 week, 2 weeks, 3 weeks, 4 weeks after the treatment.
- Conditions
- Posner Schlossman Syndrome
- Being tested
- FK-506 (Drug), Prednisolone Acetate 1% Oph Susp
- Keywords
- Posner Schlossman Syndrome, FK-506, effectiveness, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FK-506 (Drug)Drug
Also called Tacrolimus eye drops
Twice a day
Prednisolone Acetate 1% Oph SuspDrug
Four times a day
| Study group | Role | What they receive |
|---|---|---|
| The experimental group | Experimental | Not described Receives: Drug: FK-506 (Drug) |
| The control group | Sham comparator | Not described Receives: Drug: Prednisolone Acetate 1% Oph Susp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Silt-lamp examination of the cornea
KP numbers after the treatment
Measured: 1 week after the treatment
Silt-lamp examination of the cornea
KP numbers after the treatment
Measured: 2 weeks after the treatment
Silt-lamp examination of the cornea
KP numbers after the treatment
Measured: 3 weeks after the treatment
Silt-lamp examination of the cornea
KP numbers after the treatment
Measured: 4 weeks after the treatment
Secondary outcomes (4)
Goldmann ophthalmotonometer examination of intra-ocular pressure
change of intra-ocular pressure
Measured: 1 week after the treatment
Goldmann ophthalmotonometer examination of intra-ocular pressure
change of intra-ocular pressure
Measured: 2 weeks after the treatment
Goldmann ophthalmotonometer examination of intra-ocular pressure
change of intra-ocular pressure
Measured: 3 weeks after the treatment
Goldmann ophthalmotonometer examination of intra-ocular pressure
change of intra-ocular pressure
Measured: 4 weeks after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Oct 2020
- Primary completionAug 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posner Schlossman SyndromeStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Zhang, Peking University
- Investigators
- Chun Zhang, PHD,MD, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590183
- Sponsor's protocol ID
- IRB00006761-M2020059
- Status last verified
- Aug 2021
- First submitted
- 14 Sep 2020
- Last updated
- 16 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peking University Third Hospital Medical Science Research Ethics Committee
- ClinicalTrials.gov ID
- NCT04590183
- Acronym / sponsor ID
- IRB00006761-M2020059
- Conditions
- Posner Schlossman Syndrome
- Keywords
- Posner Schlossman Syndrome, FK-506, effectiveness, safety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 19 Oct 2020 (actual)
- 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.
To evaluate the effectiveness and safety of tacrolimus eye drops (FK-506) in the treatment of Posner-Schlossman Syndrome. It is expected to collect 30 patients with PSS who are in the Ophthalmology Department of Peking University Third Hospital. The included PSS patients were divided into experimental group and control group using simple randomization method. Among them, the experimental group was treated with FK-506 twice a day, and the control group was treated with prednisolone acetate ophthalmic suspension 1% 4 times a day.
For all PSS patients whose intraocular pressure is higher than 30mmHg, also add brinzolamide eye drops 3 times a day. Best corrected visual acuity, Goldmann intraocular pressure, anterior section photographs, corneal endothelial cells，corneal confocal microscope, Heidelberg retinal nerve analysis, Octopus visual field were examined on baseline and 1 week, 2 weeks, 3 weeks, 4 weeks after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The experimental group | Experimental | Drug: FK-506 (Drug) |
| The control group | Sham comparator | Drug: Prednisolone Acetate 1% Oph Susp |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of PSS Must be able to communicate with doctor and understand this study
Key exclusion criteria (1 listed)
- Fuchs syndrome
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 |
|---|---|---|
| FK-506 (Drug)Also: Tacrolimus eye dropsTwice a day | Drug | The experimental group |
| Prednisolone Acetate 1% Oph SuspFour times a day | Drug | The control group |
Primary outcome
Silt-lamp examination of the cornea
Time frame: 1 week after the treatment
KP numbers after the treatment
Silt-lamp examination of the cornea
Time frame: 2 weeks after the treatment
KP numbers after the treatment
Silt-lamp examination of the cornea
Time frame: 3 weeks after the treatment
KP numbers after the treatment
Silt-lamp examination of the cornea
Time frame: 4 weeks after the treatment
KP numbers after the treatment
4 secondary outcomes
Goldmann ophthalmotonometer examination of intra-ocular pressure
Time frame: 1 week after the treatment
Goldmann ophthalmotonometer examination of intra-ocular pressure
Time frame: 2 weeks after the treatment
Goldmann ophthalmotonometer examination of intra-ocular pressure
Time frame: 3 weeks after the treatment
Goldmann ophthalmotonometer examination of intra-ocular pressure
Time frame: 4 weeks after the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Individual participant dataSharing planned: No
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.
Chun Zhang, PHD,MD study director
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FK-506 (Drug) and Prednisolone Acetate 1% Oph Susp in people with Posner Schlossman Syndrome, run by Peking University at 1 site in China.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Aug 2021. 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 China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tingting Gao, PHD (0086-13795176872, gaotingting8139@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Silt-lamp examination of the cornea (time frame: 1 week after the treatment). The study lists 4 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 16 Aug 2021.