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

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.

• Experimental: QLS-111 ophthalmic solution, (0.015%) (Drug), also known as QLS-111: 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%) (Drug), also known as QLS-111: 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%) (Drug), also known as QLS-111: 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.
• QLS-111 ophthalmic vehicle solution (Other), also known as vehicle, placebo: 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 outcomes

• Incidence of ocular symptoms and ocular treatment-emergent adverse events (TEAEs) [21 days]: Ocular safety and tolerability: adverse events (AEs)
• Clinically significant change in visual acuity [21 days]: Ocular safety and tolerability: visual acuity
• Clinically significant change in findings on slit lamp exam [21 days]: Ocular safety and tolerability: slit lamp
• Clinically significant change in findings on fundus exam [21 days]: Ocular safety and tolerability: fundus
• Incidence of systemic TEAEs [21 days]: Systemic safety and tolerability: AEs
• Clinically significant changes in blood pressure (BP) [21 days]: Systemic safety and tolerability: vital signs
• Clinically significant changes in heart rate (HR) [21 days]: Systemic safety and tolerability: vital signs

Secondary outcomes

• Change from baseline (CFB) of diurnal intraocular pressure (IOP) in the study eye [21 days]: Ocular hypotensive efficacy: diurnal IOP CFB
• CFB in IOP at various timepoints in the study eye [up to 21 days]: Ocular hypotensive efficacy: CFB for multiple timepoints throughout day

Sex: All, ages: 18 Years to any

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

• Lisa Brandano, Study director, Qlaris Bio, Inc.