A Study to Determine the Safety and Tolerability of 2 Concentrations of QLS-101
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ClinicalTrials.gov Identifier: NCT04947124 |
Recruitment Status :
Completed
First Posted : July 1, 2021
Last Update Posted : August 23, 2022
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Condition or disease | Intervention/treatment | Phase |
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Sturge-Weber Syndrome (SWS) Glaucoma Glaucoma Congenital Ocular Hypertension | Drug: QLS-101ophthalmic solution 1% Drug: QLS-101ophthalmic solution 2% | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | Patients take 2 different doses of investigational product at distinct treatment periods. Dose is masked. |
Masking: | Double (Participant, Investigator) |
Masking Description: | Masked investigational product labeling. |
Primary Purpose: | Treatment |
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) |
Actual Study Start Date : | October 19, 2021 |
Actual Primary Completion Date : | June 6, 2022 |
Actual Study Completion Date : | August 1, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: 1% QLS-101
dosed once a day for 14 days as either first or second dosing period per randomization
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Drug: QLS-101ophthalmic solution 1%
QLS-101ophthalmic solution 1.0%
Other Name: QLS-101 |
Experimental: 2% QLS-101
dosed once a day for 14 as either first or second dosing period per randomization
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Drug: QLS-101ophthalmic solution 2%
QLS-101ophthalmic solution 2.0%
Other Name: QLS-101 |
- Ocular 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
- Ocular hypotensive efficacy [ Time Frame: 14 days after each dosing timepoint is completed ]Mean change in IOP from baseline following 14 days dosing

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04947124
United States, North Carolina | |
Duke Eye Center | |
Durham, North Carolina, United States, 27710 |
Responsible Party: | Qlaris Bio, Inc. |
ClinicalTrials.gov Identifier: | NCT04947124 |
Other Study ID Numbers: |
QC-203 |
First Posted: | July 1, 2021 Key Record Dates |
Last Update Posted: | August 23, 2022 |
Last Verified: | July 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Sturge-Weber Syndrome Glaucoma Elevated IOP |
Sturge-Weber Syndrome Brain Stem Infarctions Glaucoma Ocular Hypertension Hydrophthalmos Klippel-Trenaunay-Weber Syndrome Syndrome Disease Pathologic Processes Vascular Diseases Cardiovascular Diseases Eye Diseases Brain Infarction Brain Ischemia Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Stroke Infarction Ischemia Necrosis Angiomatosis Hemangioma Neoplasms, Vascular Tissue Neoplasms by Histologic Type Neoplasms Neurocutaneous Syndromes Eye Abnormalities Glaucoma, Open-Angle |