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

Glaucoma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04947124
• Other study ID #: QC-203
• Status: Completed
• Phase: Phase 2
• Start date: October 19, 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: March 2023
• Source: Qlaris Bio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: August 1, 2022
• Est. primary completion date: June 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Stem Infarctions
• Glaucoma
• Glaucoma Congenital
• Ocular Hypertension
• Sturge-Weber Syndrome
• Syndrome

Intervention

Drug:
• QLS-101ophthalmic solution 1%
QLS-101ophthalmic solution 1.0%
• QLS-101ophthalmic solution 2%
QLS-101ophthalmic solution 2.0%

Locations

Country	Name	City	State
United States	Duke Eye Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Qlaris Bio, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular adverse events (AEs)	Standard safety endpoint, ocular AEs, (including elevated IOP)	56 days, including a 14-day washout
Primary	Visual acuity	Standard safety endpoint, best corrected visual acuity, Snellen score, change from baseline	56 days, including a 14-day washout
Primary	Enhance depth imaging optical coherence tomography (EDI-OCT)	Standard safety endpoint, EDI-OCT, corneal thickness	56 days, including a 14-day washout
Primary	Slit lamp exam	Standard safety endpoint, slit lamp exam, abnormalities, changes from baseline	56 days, including a 14-day washout
Primary	Dilated fundus exam	Fundus exam, abnormalities, changes from baseline	56 days, including a 14-day washout
Secondary	Ocular hypotensive efficacy	Mean change in IOP from baseline following 14 days dosing	14 days after each dosing timepoint is completed

External Links

•   Qlaris Bio website, pipeline page