Study of an Investigational Product, QLS-111, Provided as an Eyedrop, for Treatment of Normal Tension Glaucoma (NTG)

A randomized, active-controlled, multi-site, double-masked, pilot study to evaluate the safety and tolerability of QLS-111 0.015% versus Timolol maleate ophthalmic preservative free (PF) 0.5% ophthalmic solution in subjects with NTG. Primary objective is to evaluate the ocular and systemic safety and tolerability of QLS-111 0.015% compared to active control (Timolol).

Secondary objective is to evaluate the ocular hypotensive efficacy of QLS-111 0.015% with once daily evening (QPM) and twice daily (BID) dosing versus Timolol with QPM dosing.

• QLS-111 ophthalmic solution (0.015%) (Drug), also known as QLS-111: QLS-111 ophthalmic solution 0.015% applied QPM OU for 7 days followed by BID dosing OU for 7 days, to constitute a 14-day study treatment period. All IP for this study will be supplied masked in PF single use vials.
• Timolol Maleate PF 0.5% Ophthalmic Solution (Timolol) (Drug), also known as Timolol: Timolol BID: Timolol Maleate PF 0.5% Ophthalmic Solution (Timolol) with BID dosing OU will be administered up to 14 days. 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) [14 days]: Ocular safety and tolerability: (AEs)
• Clinically significant change in visual acuity [14 days]: Ocular safety and tolerability: visual acuity
• Clinically significant change in findings on slit lamp exam [14 days]: Ocular safety and tolerability: dilated biomicroscopy of eye to observe clinically significant changes from baseline
• Clinically significant change in findings on fundus exam [14 days]: Ocular safety and tolerability: dilated ophthalmoscopy to observe clinically significant changes from baseline in posterior segment of eye
• Incidence of systemic TEAEs [14 days]: Systemic safety and tolerability: AEs
• Clinically significant changes in blood pressure (BP) [14 days]: Systemic safety and tolerability: vital sign, measuring systolic and diastolic blood pressure
• Clinically significant changes in heart rate (HR) [14 days]: Systemic safety and tolerability: vital signs

Secondary outcomes

• Change from baseline (CFB) of diurnal intraocular pressure (IOP) in the study eye [14 days]: Ocular hypotensive efficacy: diurnal IOP CFB
• CFB in IOP at various timepoints in the study eye [14 days]: Ocular hypotensive efficacy: IOP CFB for multiple timepoints throughout the day

Sex: All, ages: 30 Years to any

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 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

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