Qlaris Phase 2 Study in NTG Patients
Normal Tension Glaucoma, Low-Tension Glaucoma, Bilateral, Low-Tension Glaucoma, Unspecified Eye
About this trial
This is an interventional treatment trial for Normal Tension Glaucoma focused on measuring NTG, Qlaris, intraocular pressure (IOP), Glaucoma
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
Sites / Locations
- To be determined
- To be determined
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
QLS-111 ophthalmic solution
QLS-111 ophthalmic vehicle solution
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.