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

NCT04947124 | Completed Phase 2 FDA Drug

• 1 other identifier: QC-203
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Keywords

Sturge-Weber Syndrome; Glaucoma; Elevated Intraocular pressure (IOP)

Outcome Measures

Primary Outcomes (5)

• Ocular adverse events (AEs)

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

  56 days, including a 14-day washout

• Visual acuity

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

  56 days, including a 14-day washout

• Enhance depth imaging optical coherence tomography (EDI-OCT)

  Standard safety endpoint, EDI-OCT, corneal thickness

  56 days, including a 14-day washout

• Slit lamp exam

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

  56 days, including a 14-day washout

• Dilated fundus exam

  Fundus exam, abnormalities, changes from baseline

  56 days, including a 14-day washout

Secondary Outcomes (1)

• Ocular hypotensive efficacy

  14 days after each dosing timepoint is completed

Study Arms (2)

1% QLS-101

EXPERIMENTAL

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

Drug: QLS-101ophthalmic solution 1%

2% QLS-101

EXPERIMENTAL

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

Drug: QLS-101ophthalmic solution 2%

Interventions

QLS-101ophthalmic solution 1% DRUG

QLS-101ophthalmic solution 1.0%

Also known as: QLS-101

1% QLS-101

QLS-101ophthalmic solution 2% DRUG

QLS-101ophthalmic solution 2.0%

Also known as: QLS-101

2% QLS-101

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Qlaris Bio, Inc.: lead

Study Sites (1)

Duke Eye Center

Durham, North Carolina, 27710, United States

Location

Related Links

• Qlaris Bio website, pipeline page

MeSH Terms

Conditions

Sturge-Weber Syndrome; Glaucoma; Hydrophthalmos; Ocular Hypertension

Condition Hierarchy (Ancestors)

Hemangioma; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms; Neurocutaneous Syndromes; Nervous System Diseases; Angiomatosis; Vascular Diseases; Cardiovascular Diseases; Eye Diseases; Eye Abnormalities; Glaucoma, Open-Angle; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• B. Wirostko, M.D.

  Qlaris Bio, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Masked investigational product labeling.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients take 2 different doses of investigational product at distinct treatment periods. Dose is masked.

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: July 1, 2021
• Study Start: October 19, 2021
• Primary Completion: June 6, 2022
• Study Completion: August 1, 2022
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)