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Qlaris Phase 2 Study in NTG Patients

Primary Purpose

Normal Tension Glaucoma, Low-Tension Glaucoma, Bilateral, Low-Tension Glaucoma, Unspecified Eye

Status
Not yet recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
QLS-111 ophthalmic solution, (0.015%)
QLS-111 ophthalmic solution, (0.03%)
QLS-111 ophthalmic vehicle solution
Sponsored by
Qlaris Bio, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Normal Tension Glaucoma focused on measuring NTG, Qlaris, intraocular pressure (IOP), Glaucoma

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 30 years or older Able to provide written acknowledgement of giving informed consent Best corrected visual acuity (BCVA) 20/200 or better NTG in one or both eyes with untreated IOP <21 mmHg at Visit 2 and morning assessment of Visit 3; IOP at morning assessment on Visits 2 and 3 doesn't differ more than 2 mmHg; has open iridocorneal angles, historic IOP <22 mmHg in either eye Exclusion Criteria: History of angle closure glaucoma, narrow or occludable angle on gonioscope All secondary glaucomas 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 1.5 years from study) Ocular trauma, ocular infections, ocular inflammation, herpes simplex keratitis of eye Use of other ophthalmic concomitant medications during the study Refractive surgery 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

Sites / Locations

  • To be determined
  • To be determined

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

QLS-111 ophthalmic solution

QLS-111 ophthalmic vehicle solution

Arm Description

Qlaris' investigational product, QLS-111 ophthalmic solution, provided in 2 concentrations for this study (0.15% and 0.03%), single use vials, masked, and preservative free (PF).

Inactive control. QLS-111 ophthalmic vehicle solution, single use vials, masked, PF.

Outcomes

Primary Outcome Measures

Incidence of ocular symptoms and ocular treatment-emergent adverse events (TEAEs)
Ocular safety and tolerability: (AEs)
Clinically significant change in visual acuity
Ocular safety and tolerability: visual acuity
Clinically significant change in findings on slit lamp exam
Ocular safety and tolerability: dilated biomicroscopy of eye to observe clinically significant changes from baseline
Clinically significant change in findings on fundus exam
Ocular safety and tolerability: dilated ophthalmoscopy to observe clinically significant changes from baseline in posterior segment of eye
Incidence of systemic TEAEs
Systemic safety and tolerability: AEs
Clinically significant changes in blood pressure (BP)
Systemic safety and tolerability: vital sign, measuring systolic and diastolic blood pressure
Clinically significant changes in heart rate (HR)
Systemic safety and tolerability: vital signs

Secondary Outcome Measures

Change from baseline (CFB) of diurnal intraocular pressure (IOP) in the study eye
Ocular hypotensive efficacy: diurnal IOP CFB
CFB in IOP at various timepoints in the study eye
Ocular hypotensive efficacy: IOP CFB for multiple timepoints throughout the day

Full Information

First Posted
August 18, 2023
Last Updated
September 6, 2023
Sponsor
Qlaris Bio, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06030193
Brief Title
Qlaris Phase 2 Study in NTG Patients
Official Title
A Randomized, Vehicle-controlled, Double-masked Study to Evaluate the Safety and Tolerability of QLS-111 Versus Vehicle in Subjects With Normal Tension Glaucoma (NTG)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 9, 2024 (Anticipated)
Primary Completion Date
January 17, 2025 (Anticipated)
Study Completion Date
February 7, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qlaris Bio, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Qlaris' Phase 2 clinical trial investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in normal tension glaucoma patients.
Detailed 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 NTG. Primary objective is to evaluate the ocular and systemic safety and tolerability of 2 concentrations of QLS-111 compared to vehicle control. Secondary objective is to evaluate the ocular hypotensive efficacy of 2 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Normal Tension Glaucoma, Low-Tension Glaucoma, Bilateral, Low-Tension Glaucoma, Unspecified Eye, Glaucoma
Keywords
NTG, Qlaris, intraocular pressure (IOP), Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Multi site double masked, vehicle-controlled, randomized, prospective parallel study of 7 days' QAM dosing, followed by 7 days' QPM dosing, and 7 days' BID dosing (7 days of dosing per regimen [21-day treatment period])of an investigational product (IP), QLS-111 or vehicle. Both eyes (OU) will be dosed.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Study subjects, Investigators and their staff, and Sponsor personnel involved with the conduct and monitoring of the study will be masked to the IP identity until after the final database is locked. IP will be provided in identical appearing packaging. Unmasked statistician preparing the masked randomization schedule.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
QLS-111 ophthalmic solution
Arm Type
Experimental
Arm Description
Qlaris' investigational product, QLS-111 ophthalmic solution, provided in 2 concentrations for this study (0.15% and 0.03%), single use vials, masked, and preservative free (PF).
Arm Title
QLS-111 ophthalmic vehicle solution
Arm Type
Placebo Comparator
Arm Description
Inactive control. QLS-111 ophthalmic vehicle solution, single use vials, masked, PF.
Intervention Type
Drug
Intervention Name(s)
QLS-111 ophthalmic solution, (0.015%)
Other Intervention Name(s)
QLS-111
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
QLS-111 ophthalmic solution, (0.03%)
Other Intervention Name(s)
QLS-111
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
QLS-111 ophthalmic vehicle solution
Other Intervention Name(s)
Vehicle, Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of ocular symptoms and ocular treatment-emergent adverse events (TEAEs)
Description
Ocular safety and tolerability: (AEs)
Time Frame
21 days
Title
Clinically significant change in visual acuity
Description
Ocular safety and tolerability: visual acuity
Time Frame
21 days
Title
Clinically significant change in findings on slit lamp exam
Description
Ocular safety and tolerability: dilated biomicroscopy of eye to observe clinically significant changes from baseline
Time Frame
21 days
Title
Clinically significant change in findings on fundus exam
Description
Ocular safety and tolerability: dilated ophthalmoscopy to observe clinically significant changes from baseline in posterior segment of eye
Time Frame
21 days
Title
Incidence of systemic TEAEs
Description
Systemic safety and tolerability: AEs
Time Frame
21 days
Title
Clinically significant changes in blood pressure (BP)
Description
Systemic safety and tolerability: vital sign, measuring systolic and diastolic blood pressure
Time Frame
21 days
Title
Clinically significant changes in heart rate (HR)
Description
Systemic safety and tolerability: vital signs
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Change from baseline (CFB) of diurnal intraocular pressure (IOP) in the study eye
Description
Ocular hypotensive efficacy: diurnal IOP CFB
Time Frame
21 days
Title
CFB in IOP at various timepoints in the study eye
Description
Ocular hypotensive efficacy: IOP CFB for multiple timepoints throughout the day
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 30 years or older Able to provide written acknowledgement of giving informed consent Best corrected visual acuity (BCVA) 20/200 or better NTG in one or both eyes with untreated IOP <21 mmHg at Visit 2 and morning assessment of Visit 3; IOP at morning assessment on Visits 2 and 3 doesn't differ more than 2 mmHg; has open iridocorneal angles, historic IOP <22 mmHg in either eye Exclusion Criteria: History of angle closure glaucoma, narrow or occludable angle on gonioscope All secondary glaucomas 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 1.5 years from study) Ocular trauma, ocular infections, ocular inflammation, herpes simplex keratitis of eye Use of other ophthalmic concomitant medications during the study Refractive surgery 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Brandano
Phone
9789302103
Email
lbrandano@qlaris.bio
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel DeWalt
Email
ddewalt@qlaris.bio
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Brandano
Organizational Affiliation
Qlaris Bio, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
To be determined
City
Seoul
Country
Korea, Republic of
Facility Name
To be determined
City
Manila
Country
Philippines

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://qlaris.bio
Description
Company website, pipeline

Learn more about this trial

Qlaris Phase 2 Study in NTG Patients

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