Qlaris Phase 2 Study of QLS-111 in POAG and/or OHT Patients

Primary Open Angle Glaucoma (POAG) Clinical Trial

Official title:

A Randomized, Multi-site, Double-masked Study Evaluating the Safety and Tolerability of QLS-111 vs Vehicle in Primary Open-angle Glaucoma or Ocular Hypertension Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06016972
• Other study ID #: QC-111-201
• Secondary ID: Osprey
• Status: Recruiting
• Phase: Phase 2
• Start date: March 15, 2024
• Est. completion date: September 5, 2024

Study information

• Verified date: August 2023
• Source: Qlaris Bio, Inc.
• Contact: Lisa Brandano
• Phone: 9789302103
• Email: lbrandano[@]qlaris.bio
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Qlaris' Phase 2 clinical trial investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in primary open-angle glaucoma (POAG) or ocular hypertension patients.

Description:

A randomized, active- and vehicle-controlled, multi-site, double-masked study to evaluate the safety and tolerability of QLS-111 versus vehicle in subjects with primary open-angle glaucoma or ocular hypertension. Primary objective is to evaluate the ocular and systemic safety and tolerability of 3 concentrations of QLS-111 compared to vehicle control. Secondary objective is to evaluate the ocular hypotensive efficacy of 3 concentrations of QLS-111 with once daily morning (QAM), once daily evening (QPM), and twice daily (BID) dosing versus vehicle with QAM, QPM, and BID dosing.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 5, 2024
• Est. primary completion date: September 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older

• Able to provide written acknowledgement of giving informed consent

• Best corrected visual acuity (BCVA) 20/200 or better Bilateral POAG or OHT with documented historic IOP value(s) =24 mmHg, in either eye

• Post-washout IOP =22 mmHg in morning on Visits 2 and 3 and =18 mmHg at noon on Visit 2

Exclusion Criteria:

• IOP >34 mmHg

• Severe glaucomatous damage that would preclude safe washout of prescribed ocular hypotensive medications

• Previous glaucoma surgery, certain procedures (trabeculotomy, shunt/tubes, cyclodestructive procedure) (selective laser trabeculoplasty (SLT) allowed if done no earlier than 1 year from study, some minimally invasive glaucoma surgeries are allowed if done no earlier than 1 year from study)

• Ocular trauma, ocular infections, ocular inflammation, herpes simplex keratitis of eye

• Use of other ophthalmic concomitant medications during the study

• Uncontrolled hypertension or hypotension

• Significant systemic or psychiatric disease

• Participation in other investigational trial 30 days prior to screening or previous enrollment and treatment with Qlaris investigational product

• Pregnant or lactating

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Ocular Hypertension (OHT)
• Primary Open Angle Glaucoma (POAG)
• Primary Open Angle Glaucoma of Both Eyes
• Primary Open-Angle Glaucoma, Unspecified Eye

Intervention

Drug:
• Experimental: QLS-111 ophthalmic solution, (0.015%)
QLS-111 ophthalmic solution, (0.015%) applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.
• Experimental: QLS-111 ophthalmic solution, (0.03%)
QLS-111 ophthalmic solution, (0.03%) applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.
• Experimental: QLS-111 ophthalmic solution, (0.075%)
QLS-111 ophthalmic solution, (0.075%) applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.

Other:
• QLS-111 ophthalmic vehicle solution
Vehicle ophthalmic solution applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.

Locations

Country	Name	City	State
United States	Coastal Research Associates, LLC	Roswell	Georgia

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	Incidence of ocular symptoms and ocular treatment-emergent adverse events (TEAEs)	Ocular safety and tolerability: adverse events (AEs)	21 days
Primary	Clinically significant change in visual acuity	Ocular safety and tolerability: visual acuity	21 days
Primary	Clinically significant change in findings on slit lamp exam	Ocular safety and tolerability: slit lamp	21 days
Primary	Clinically significant change in findings on fundus exam	Ocular safety and tolerability: fundus	21 days
Primary	Incidence of systemic TEAEs	Systemic safety and tolerability: AEs	21 days
Primary	Clinically significant changes in blood pressure (BP)	Systemic safety and tolerability: vital signs	21 days
Primary	Clinically significant changes in heart rate (HR)	Systemic safety and tolerability: vital signs	21 days
Secondary	Change from baseline (CFB) of diurnal intraocular pressure (IOP) in the study eye	Ocular hypotensive efficacy: diurnal IOP CFB	21 days
Secondary	CFB in IOP at various timepoints in the study eye	Ocular hypotensive efficacy: CFB for multiple timepoints throughout day	up to 21 days

External Links

•   Company website, pipeline