Qlaris Phase 2 Study in NTG Patients

• Status: Not yet recruiting
• Trial end date: 2025-03-07
• Target enrollment: 0
• Participant gender: All

Summary

Qlaris' Phase 2 clinical trial investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in normal tension glaucoma patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qlaris Bio, Inc.
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

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