ClinicalTrials.gg
CompletedNCT05495269Updated Jan 20, 2025

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 interventional study of QLS-101 ophthalmic solution, 2.0 % in Sturge-Weber Syndrome, Glaucoma and Ocular Hypertension, sponsored by Qlaris Bio, Inc.. Completed at 1 site in United States. Open to participants aged 12 Years to 19 Years. Per ClinicalTrials.gov, last updated 2025-01-20.

Sponsored by Qlaris Bio, Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Jan 2023, 3 years 9 months ago, and no results have been posted to the registry; the sponsor requested a delay in submitting them in Mar 2023.
Phase
Phase 2
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
12 Years to 19 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 490 studies in Glaucoma with a site in United States — 75 open to participants now, 95 under way, 5 of them phase 3. Glaucoma · United States.

Enrollment
353rd of 364
2 · median 79
Started
2022
with 20 others
Phase 2
66 of 490
4 open now
Registered
383rd of 490
by date

Among the 490 studies in Glaucoma with a site in United States, this one is the 353rd largest by enrollment of the 364 interventional ones that give a count, is one of 21 that started in 2022, is one of 66 in phase 2, and was the 383rd registered.

Glaucoma

1,419 studies on the registry are indexed under Glaucoma; 221 are open to participants now.

Browse Glaucoma studies →

Open to participants now

75 of the 490 studies in Glaucoma with a site in United States are open now. Recruiting first, the newest first:

70 more — sign in →

All 75 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 155 Glaucoma studies recruiting now, 113 (73%) set no upper age limit and 9 (6%) stop at 75 or younger; 13 take children under 18; 44 take healthy volunteers.

This study: 12 Years to 19 Years · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Sturge-Weber Syndrome
  • Glaucoma
  • Ocular Hypertension
04

Who can participate

Ages eligible
12 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 and follow study instructions

Exclusion criteria

Exclusion Criteria:

  • Expected to undergo IOP-lowering surgery
  • Incisional or laser surgery of any type 4 months prior to study
  • Ocular infection, inflammation, blepharitis or conjunctivitis, history of herpes simplex keratitis in either eye
  • History of or active clinically significant ocular disease
  • Use of topical ocular in the 6 weeks prior to study
  • Patient cannot be applanated or tolerate IOP measurements
  • 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    QLS-101, 2.0%

    Qlaris' investigational product, QLS-101, 2.0% concentration, ocular administration (eye drop), given once daily in the morning to both eyes

    Drug: QLS-101 ophthalmic solution, 2.0 %

Interventions

06

What researchers measure

Primary outcomes

  1. Ocular safety

    Incidence of ocular treatment emergent adverse events (TEAEs)

    Time frame: Over 28 days

  2. Systemic safety

    Incidence of systemic TEAEs

    Time frame: 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

    Time frame: 28 days

07

Study locations

1 site
  • Duke Eye Center
    Durham, North Carolina 27710, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2022 to primary completion in Jan 2023, 2 months.

Of 23 industry-sponsored phase 2 interventional studies under Glaucoma, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 11. This study's 2 months is below that.

Counting every sponsor, half of 32 studies reached it within 11 months; a quarter within 6 and three quarters within 22.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 2, 2022
First posted
Aug 10, 2022
StartActual
Nov 23, 2022
Primary completionActual
Jan 25, 2023
CompletionActual
Mar 20, 2023
Results delay requested
Mar 21, 2023
Last update
Jan 20, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05495269
Lead sponsor
Qlaris Bio, Inc.
Responsible party
Sponsor
First posted
Aug 10, 2022
Start date
Nov 23, 2022
Primary completion
Jan 25, 2023
Completion
Mar 20, 2023
Last update
Jan 20, 2025

Study contacts

Sharon Freedman, M.D.
principal investigator · Duke Eye Center

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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