Qlaris Phase 2 Study in NTG Patients

Study Overview
=================
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.

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)

Conditions
-----------------
Glaucoma, Normal Tension Glaucoma (NTG), Low-Tension Glaucoma, Bilateral, Low-Tension Glaucoma, Unspecified Eye

Intervention / Treatment
-----------------
* Drug: QLS-111 ophthalmic solution, (0.015%)
* Drug: QLS-111 ophthalmic solution, (0.03%)
* Other: QLS-111 ophthalmic vehicle solution


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QLS-111 ophthalmic solution<br>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). | Drug: QLS-111 ophthalmic solution, (0.015%)<br>* 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.<br>* Other names: QLS-111;Drug: QLS-111 ophthalmic solution, (0.03%)<br>* 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.<br>* Other names: QLS-111;|
| Placebo Comparator: QLS-111 ophthalmic vehicle solution<br>Inactive control. QLS-111 ophthalmic vehicle solution, single use vials, masked, PF. | Other: QLS-111 ophthalmic vehicle solution<br>* 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.<br>* Other names: Placebo;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ocular symptoms and ocular treatment-emergent adverse events (TEAEs) | Ocular safety and tolerability: (AEs) | 21 days | 
| Clinically significant change in visual acuity | Ocular safety and tolerability: visual acuity | 21 days | 
| 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 | 
| 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 | 
| Incidence of systemic TEAEs | Systemic safety and tolerability: AEs | 21 days | 
| Clinically significant changes in blood pressure (BP) | Systemic safety and tolerability: vital sign, measuring systolic and diastolic blood pressure | 21 days | 
| Clinically significant changes in heart rate (HR) | Systemic safety and tolerability: vital signs | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline (CFB) of diurnal intraocular pressure (IOP) in the study eye | Ocular hypotensive efficacy: diurnal IOP CFB | 21 days | 
| CFB in IOP at various timepoints in the study eye | Ocular hypotensive efficacy: IOP CFB for multiple timepoints throughout the day | 21 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NTG, Qlaris, intraocular pressure (IOP), Glaucoma, Nightingale, low-tension glaucoma