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

Sponsor

Qlaris Bio, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04947124

Collaborator

(none)

Enrollment

Location

Arms

9.4

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Sturge-Weber Syndrome (SWS) Glaucoma Glaucoma Congenital Ocular Hypertension	Drug: QLS-101ophthalmic solution 1% Drug: QLS-101ophthalmic solution 2%	Phase 2

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.

Study Design

Study Type:

Interventional

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.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 :

Oct 19, 2021

Actual Primary Completion Date :

Jun 6, 2022

Actual Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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% QLS-101ophthalmic solution 1.0% Other Names: QLS-101
Experimental: 2% QLS-101 dosed once a day for 14 as either first or second dosing period per randomization	Drug: QLS-101ophthalmic solution 2% QLS-101ophthalmic solution 2.0% Other Names: QLS-101

Arm

Intervention/Treatment

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%

QLS-101ophthalmic solution 1.0%

Other Names:

QLS-101

Experimental: 2% QLS-101

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

Drug: QLS-101ophthalmic solution 2%

QLS-101ophthalmic solution 2.0%

Other Names:

QLS-101

Outcome Measures

Primary Outcome Measures

Ocular AEs [56 days, including a 14-day washout]
Standard safety endpoint, ocular AEs, (including elevated IOP)
Visual acuity [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) [56 days, including a 14-day washout]
Standard safety endpoint, EDI-OCT, corneal thickness
Slit lamp exam [56 days, including a 14-day washout]
Standard safety endpoint, slit lamp exam, abnormalities, changes from baseline
Dilated fundus exam [56 days, including a 14-day washout]
Fundus exam, abnormalities, changes from baseline

Secondary Outcome Measures

Ocular hypotensive efficacy [14 days after each dosing timepoint is completed]
Mean change in IOP from baseline following 14 days dosing

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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