Qlaris Phase 2 Study in NTG Patients

Phase 2

Not yet recruiting

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

• Registration Number: NCT06030193
• Lead Sponsor: Qlaris Bio, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-8-18
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - 30 years or older<br><br> - Able to provide written acknowledgement of giving informed consent<br><br> - Best corrected visual acuity (BCVA) 20/200 or better<br><br> - NTG in one or both eyes with untreated IOP <21 mmHg at Visit 2 and morning<br> assessment of Visit 3; IOP at morning assessment on Visits 2 and 3 doesn't differ<br> more than 2 mmHg; has open iridocorneal angles, historic IOP <22 mmHg in either eye<br><br>Exclusion Criteria:<br><br> - History of angle closure glaucoma, narrow or occludable angle on gonioscope<br><br> - All secondary glaucomas<br><br> - Severe glaucomatous damage that would preclude safe washout of prescribed ocular<br> hypotensive medications<br><br> - Previous glaucoma surgery, certain procedures (trabeculotomy, shunt/tubes,<br> cyclodestructive procedure) (selective laser trabeculoplasty (SLT) allowed if done<br> no earlier than 1 year from study, some minimally invasive glaucoma surgeries are<br> allowed if done no earlier than 1.5 years from study)<br><br> - Ocular trauma, ocular infections, ocular inflammation, herpes simplex keratitis of<br> eye<br><br> - Use of other ophthalmic concomitant medications during the study<br><br> - Refractive surgery<br><br> - Uncontrolled hypertension or hypotension<br><br> - Significant systemic or psychiatric disease<br><br> - Participation in other investigational trial 30 days prior to screening or previous<br> enrollment and treatment with Qlaris investigational product<br><br> - Pregnant or lactating

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of ocular symptoms and ocular treatment-emergent adverse events (TEAEs);Clinically significant change in visual acuity;Clinically significant change in findings on slit lamp exam;Clinically significant change in findings on fundus exam;Incidence of systemic TEAEs;Clinically significant changes in blood pressure (BP);Clinically significant changes in heart rate (HR)

Secondary Outcome Measures

Name	Time	Method
Change from baseline (CFB) of diurnal intraocular pressure (IOP) in the study eye;CFB in IOP at various timepoints in the study eye