Sturge-Weber Syndrome (SWS)Phase 2NCT04947124
A Study to Determine the Safety and Tolerability of 2 Concentrations of QLS-101
A Phase 2 study testing QLS-101ophthalmic solution 1% and QLS-101ophthalmic solution 2% in people with Sturge-Weber Syndrome (SWS) and Glaucoma, run by Qlaris Bio, Inc. at 1 site in United States.
Trial summary
Safety and tolerability study of 2 concentrations of QLS-101 for adult subjects with Sturge Weber Syndrome (SWS)-related glaucoma due to elevated episcleral venous pressure (EVP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sturge-Weber Syndrome (SWS), Glaucoma, Glaucoma Congenital
- What is being tested?
- QLS-101ophthalmic solution 1% and QLS-101ophthalmic solution 2%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2021to 1 Aug 2022
- Phase
- Phase 2
- 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
- Diagnosed with SWS.
- Elevated intraocular pressure (IOP)
- Willing to continue current dosing regimen of IOP-lowering medications
- Willing to refrain from contact lens use in the study eye.
Who cannot join
- IOP with variability of > 4 mm Hg
- Expected to undergo IOP-lowering surgery
- Incisional or laser surgery of any type
- Ocular infection, inflammation, clinically significant blepharitis or conjunctivitis
- A history of herpes simplex keratitis in either eye.
- History of or active clinically significant ocular disease
- Use of topical ocular corticosteroids in the 6 weeks prior to Visit 1
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Masked, Randomized, Single-site, Crossover Study to Determine the Safety and Tolerability of 2 Concentrations of QLS-101 Dosed for 14 Days in Adult Subjects With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)
Safety and tolerability study of 2 concentrations of QLS-101 for adult subjects with Sturge Weber Syndrome (SWS)-related glaucoma due to elevated episcleral venous pressure (EVP).
Read the detailed description
Masked, randomized, single site, crossover study to compare 2 concentrations of QLS-101. Subjects will be randomized to one of 2 concentrations of QLS-101 for the first 14 days of daily dosing, and after a 14-day washout period they will be crossed over to the other concentration for another 14 days of daily dosing. Dose assignment is masked to patient and investigator.
- Being tested
- QLS-101ophthalmic solution 1%, QLS-101ophthalmic solution 2%
- Keywords
- Sturge-Weber Syndrome, Glaucoma, Elevated Intraocular pressure (IOP)
- Medical subject headings
- Sturge-Weber Syndrome, Glaucoma, Hydrophthalmos, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS-101ophthalmic solution 1%Drug
Also called QLS-101
QLS-101ophthalmic solution 1.0%
QLS-101ophthalmic solution 2%Drug
Also called QLS-101
QLS-101ophthalmic solution 2.0%
| Study group | Role | What they receive |
|---|---|---|
| 1% QLS-101 | Experimental | dosed once a day for 14 days as either first or second dosing period per randomization Receives: Drug: QLS-101ophthalmic solution 1% |
| 2% QLS-101 | Experimental | dosed once a day for 14 as either first or second dosing period per randomization Receives: Drug: QLS-101ophthalmic solution 2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular adverse events (AEs)
Standard safety endpoint, ocular AEs, (including elevated IOP)
Measured: 56 days, including a 14-day washout
Visual acuity
Standard safety endpoint, best corrected visual acuity, Snellen score, change from baseline
Measured: 56 days, including a 14-day washout
Enhance depth imaging optical coherence tomography (EDI-OCT)
Standard safety endpoint, EDI-OCT, corneal thickness
Measured: 56 days, including a 14-day washout
Slit lamp exam
Standard safety endpoint, slit lamp exam, abnormalities, changes from baseline
Measured: 56 days, including a 14-day washout
Dilated fundus exam
Fundus exam, abnormalities, changes from baseline
Measured: 56 days, including a 14-day washout
Secondary outcomes (1)
Ocular hypotensive efficacy
Mean change in IOP from baseline following 14 days dosing
Measured: 14 days after each dosing timepoint is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start19 Oct 2021
- Primary completion6 Jun 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sturge-Weber Syndrome (SWS)Studies 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
- Crossover
- Model description
- Patients take 2 different doses of investigational product at distinct treatment periods. Dose is masked.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qlaris Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- B. Wirostko, M.D., Study director, Qlaris Bio, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947124
- Sponsor's protocol ID
- QC-203
- Status last verified
- Jan 2025
- First submitted
- 8 Jun 2021
- Last updated
- 20 Jan 2025
- Results posted
- No
- 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 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Masked, Randomized, Single-site, Crossover Study to Determine the Safety and Tolerability of 2 Concentrations of QLS-101 Dosed for 14 Days in Adult Subjects With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)
- ClinicalTrials.gov ID
- NCT04947124
- Acronym / sponsor ID
- QC-203
- Keywords
- Sturge-Weber Syndrome, Glaucoma, Elevated Intraocular pressure (IOP)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Qlaris Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 6 Jun 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 1 Jul 2021 (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.
Safety and tolerability study of 2 concentrations of QLS-101 for adult subjects with Sturge Weber Syndrome (SWS)-related glaucoma due to elevated episcleral venous pressure (EVP).
Detailed description
Masked, randomized, single site, crossover study to compare 2 concentrations of QLS-101. Subjects will be randomized to one of 2 concentrations of QLS-101 for the first 14 days of daily dosing, and after a 14-day washout period they will be crossed over to the other concentration for another 14 days of daily dosing. Dose assignment is masked to patient and investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients take 2 different doses of investigational product at distinct treatment periods. Dose is masked.
| Arm | Type | Receives |
|---|---|---|
| 1% QLS-101 | Experimental | Drug: QLS-101ophthalmic solution 1%dosed once a day for 14 days as either first or second dosing period per randomization |
| 2% QLS-101 | Experimental | Drug: QLS-101ophthalmic solution 2%dosed once a day for 14 as either first or second dosing period per randomization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with SWS.
- Elevated intraocular pressure (IOP)
- Willing to continue current dosing regimen of IOP-lowering medications
- Willing to refrain from contact lens use in the study eye.
Key exclusion criteria (7 listed)
- IOP with variability of > 4 mm Hg
- Expected to undergo IOP-lowering surgery
- Incisional or laser surgery of any type
- Ocular infection, inflammation, clinically significant blepharitis or conjunctivitis
- A history of herpes simplex keratitis in either eye.
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 |
|---|---|---|
| QLS-101ophthalmic solution 1%Also: QLS-101QLS-101ophthalmic solution 1.0% | Drug | 1% QLS-101 |
| QLS-101ophthalmic solution 2%Also: QLS-101QLS-101ophthalmic solution 2.0% | Drug | 2% QLS-101 |
Primary outcome
Ocular adverse events (AEs)
Time frame: 56 days, including a 14-day washout
Standard safety endpoint, ocular AEs, (including elevated IOP)
Visual acuity
Time frame: 56 days, including a 14-day washout
Standard safety endpoint, best corrected visual acuity, Snellen score, change from baseline
Enhance depth imaging optical coherence tomography (EDI-OCT)
Time frame: 56 days, including a 14-day washout
Standard safety endpoint, EDI-OCT, corneal thickness
Slit lamp exam
Time frame: 56 days, including a 14-day washout
Standard safety endpoint, slit lamp exam, abnormalities, changes from baseline
Dilated fundus exam
Time frame: 56 days, including a 14-day washout
Fundus exam, abnormalities, changes from baseline
1 secondary outcome
Ocular hypotensive efficacy
Time frame: 14 days after each dosing timepoint is completed
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 20 Jan 2025.
- Qlaris Bio website, pipeline pageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
B. Wirostko, M.D. study director
Qlaris Bio, Inc.
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 QLS-101ophthalmic solution 1% and QLS-101ophthalmic solution 2% in people with Sturge-Weber Syndrome (SWS) and Glaucoma, run by Qlaris Bio, Inc. 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 4 inclusion and 7 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 20 Jan 2025. 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. 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?
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?
Ocular adverse events (AEs) (time frame: 56 days, including a 14-day washout). The study lists 5 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 20 Jan 2025.