Sturge-Weber SyndromePhase 2NCT05495269
Safety and Tolerability Study of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)
A Phase 2 study testing QLS-101 ophthalmic solution, 2.0 % in people with Sturge-Weber Syndrome and Glaucoma, run by Qlaris Bio, Inc. at 1 site in United States.
Trial summary
Open-label study of an investigational product (IP), QLS-101, with 28-day every morning (QAM) dosing to both eyes (OU) in adolescents with SWS who have clinical evidence of glaucoma and/or ocular hypertension (OHT) related to SWS elevated EVP in at least one eye. Read more about this study
- Who is it for?
- Ages 12 to 19 years
- Conditions the study is for
- Sturge-Weber Syndrome, Glaucoma, Ocular Hypertension
- What is being tested?
- QLS-101 ophthalmic solution, 2.0 %
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Nov 2022to 20 Mar 2023
- 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 12 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Between 12 and 19 years of age at Screening.
- Diagnosed with SWS
- Elevated IOP
- Willing to continue current dosing regimen of IOP-lowering medications
- Able to provide informed consent and follow study instructions
Who cannot join
- Expected to undergo IOP-lowering surgery
- Incisional or laser surgery of any type 4 months prior to study
- Ocular infection, inflammation, clinically significant blepharitis or conjunctivitis, 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 study
- Patient cannot be applanated or tolerate IOP measurements
Show all 9Show fewer
- Patient is pregnant or lactating
- Uncontrolled systemic disease that can interfere with study participation
- Inability to self-dose or identify a caregiver for all study eye drop administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot, Open-label Study of Safety and Tolerability of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)
Open-label study of an investigational product (IP), QLS-101, with 28-day every morning (QAM) dosing to both eyes (OU) in adolescents with SWS who have clinical evidence of glaucoma and/or ocular hypertension (OHT) related to SWS elevated EVP in at least one eye.
- Conditions
- Sturge-Weber Syndrome, Glaucoma, Ocular Hypertension
- Being tested
- QLS-101 ophthalmic solution, 2.0 %
- Medical subject headings
- Sturge-Weber Syndrome, Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS-101 ophthalmic solution, 2.0 %Drug
Also called QLS-101
ophthalmic solution in a single use dropper vial
| Study group | Role | What they receive |
|---|---|---|
| QLS-101, 2.0% | Experimental | Qlaris' investigational product, QLS-101, 2.0% concentration, ocular administration (eye drop), given once daily in the morning to both eyes Receives: Drug: QLS-101 ophthalmic solution, 2.0 % |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular safety
Incidence of ocular treatment emergent adverse events (TEAEs)
Measured: Over 28 days
Systemic safety
Incidence of systemic TEAEs
Measured: Over 28 days
Secondary outcomes (1)
Ocular hypotensive effectiveness
Mean change in intraocular pressure (IOP) (mmHg and % change) from baseline following 28 days dosing with QLS-101
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start23 Nov 2022
- Primary completion25 Jan 2023
- Study completion20 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sturge-Weber 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label, single treatment
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qlaris Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sharon Freedman, M.D., Principal investigator, Duke Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495269
- Sponsor's protocol ID
- QC-205
- Status last verified
- Jan 2025
- First submitted
- 2 Aug 2022
- 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
- Pilot, Open-label Study of Safety and Tolerability of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)
- ClinicalTrials.gov ID
- NCT05495269
- Acronym / sponsor ID
- QC-205
- Conditions
- Sturge-Weber Syndrome, Glaucoma, Ocular Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Qlaris Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Nov 2022 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 10 Aug 2022 (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.
Open-label study of an investigational product (IP), QLS-101, with 28-day every morning (QAM) dosing to both eyes (OU) in adolescents with SWS who have clinical evidence of glaucoma and/or ocular hypertension (OHT) related to SWS elevated EVP in at least one eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, single treatment
| Arm | Type | Receives |
|---|---|---|
| QLS-101, 2.0% | Experimental | Drug: QLS-101 ophthalmic solution, 2.0 %Qlaris' investigational product, QLS-101, 2.0% concentration, ocular administration (eye drop), given once daily in the morning to both eyes |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Between 12 and 19 years of age at Screening.
- Diagnosed with SWS
- Elevated IOP
- Willing to continue current dosing regimen of IOP-lowering medications
- Able to provide informed consent and follow study instructions
Key exclusion criteria (9 listed)
- Expected to undergo IOP-lowering surgery
- Incisional or laser surgery of any type 4 months prior to study
- Ocular infection, inflammation, clinically significant blepharitis or conjunctivitis, 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 study
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-101 ophthalmic solution, 2.0 %Also: QLS-101ophthalmic solution in a single use dropper vial | Drug | QLS-101, 2.0% |
Primary outcome
Ocular safety
Time frame: Over 28 days
Incidence of ocular treatment emergent adverse events (TEAEs)
Systemic safety
Time frame: Over 28 days
Incidence of systemic TEAEs
1 secondary outcome
Ocular hypotensive effectiveness
Time frame: 28 days
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.
- 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.
Sharon Freedman, M.D. principal investigator
Duke Eye Center
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-101 ophthalmic solution, 2.0 % in people with Sturge-Weber Syndrome 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 5 inclusion and 9 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 safety (time frame: Over 28 days). The study lists 2 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.