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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06030193
Other study ID # QC-111-202
Secondary ID Nightingale
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date June 10, 2024
Est. completion date March 7, 2025

Study information

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

Clinical Trial Summary

Qlaris' Phase 2 clinical trial investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in normal tension glaucoma 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 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date March 7, 2025
Est. primary completion date February 17, 2025
Accepts healthy volunteers No
Gender All
Age group 30 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.
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.
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
Korea, Republic of To be determined Seoul
Philippines To be determined Manila

Sponsors (1)

Lead Sponsor Collaborator
Qlaris Bio, Inc.

Countries where clinical trial is conducted

Korea, Republic of,  Philippines, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of ocular symptoms and ocular treatment-emergent adverse events (TEAEs) Ocular safety and tolerability: (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: dilated biomicroscopy of eye to observe clinically significant changes from baseline 21 days
Primary 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 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 sign, measuring systolic and diastolic blood pressure 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: IOP CFB for multiple timepoints throughout the day 21 days
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