ClinicalTrials.gg
CompletedNCT04947124Updated Jan 20, 2025

A Study to Determine the Safety and Tolerability of 2 Concentrations of QLS-101

A Phase 2 interventional study of QLS-101ophthalmic solution 1% and QLS-101ophthalmic solution 2% in Sturge-Weber Syndrome (SWS), Glaucoma and Glaucoma Congenital, sponsored by Qlaris Bio, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. 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 Jun 2022, 4 years 5 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
3
Allocation
Randomized
Ages
18 Years and older
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
351st of 364
3 · median 79
Started
2021
with 20 others
Phase 2
66 of 490
4 open now
Registered
361st of 490
by date

Among the 490 studies in Glaucoma with a site in United States, this one is the 351st largest by enrollment of the 364 interventional ones that give a count, is one of 21 that started in 2021, is one of 66 in phase 2, and was the 361st 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: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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 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.

03

Conditions studied

  • Sturge-Weber Syndrome (SWS)
  • Glaucoma
  • Glaucoma Congenital
  • Ocular Hypertension

Keywords

  • Sturge-Weber Syndrome
  • Glaucoma
  • Elevated Intraocular pressure (IOP)
04

Who can participate

Ages eligible
18 Years and older
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

  • 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.

Exclusion criteria

Exclusion Criteria:

  • IOP with variability of > 4 mm Hg
  • Expected to undergo IOP-lowering surgery
  • Incisional or laser surgery of any type
  • Ocular infection, inflammation, blepharitis or conjunctivitis
  • A 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 Visit 1
Terms in these criteria, in plain language(2)

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.

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
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    1% QLS-101

    dosed once a day for 14 days as either first or second dosing period per randomization

    Drug: QLS-101ophthalmic solution 1%

  • Experimental
    2% QLS-101

    dosed once a day for 14 as either first or second dosing period per randomization

    Drug: QLS-101ophthalmic solution 2%

Interventions

06

What researchers measure

Primary outcomes

  1. Ocular adverse events (AEs)

    Standard safety endpoint, ocular AEs, (including elevated IOP)

    Time frame: 56 days, including a 14-day washout

  2. Visual acuity

    Standard safety endpoint, best corrected visual acuity, Snellen score, change from baseline

    Time frame: 56 days, including a 14-day washout

  3. Enhance depth imaging optical coherence tomography (EDI-OCT)

    Standard safety endpoint, EDI-OCT, corneal thickness

    Time frame: 56 days, including a 14-day washout

  4. Slit lamp exam

    Standard safety endpoint, slit lamp exam, abnormalities, changes from baseline

    Time frame: 56 days, including a 14-day washout

  5. Dilated fundus exam

    Fundus exam, abnormalities, changes from baseline

    Time frame: 56 days, including a 14-day washout

Secondary outcomes

  1. Ocular hypotensive efficacy

    Mean change in IOP from baseline following 14 days dosing

    Time frame: 14 days after each dosing timepoint is completed

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

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 Oct 2021 to primary completion in Jun 2022, 7 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 7 months is close to 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
Jun 8, 2021
First posted
Jul 1, 2021
StartActual
Oct 19, 2021
Primary completionActual
Jun 6, 2022
CompletionActual
Aug 1, 2022
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
NCT04947124
Lead sponsor
Qlaris Bio, Inc.
Responsible party
Sponsor
First posted
Jul 1, 2021
Start date
Oct 19, 2021
Primary completion
Jun 6, 2022
Completion
Aug 1, 2022
Last update
Jan 20, 2025

Study contacts

B. Wirostko, M.D.
study director · Qlaris Bio, Inc.

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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