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

Launched by QLARIS BIO, INC. · Sep 6, 2023

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ClinConnect Summary

This clinical trial is studying a new eyedrop treatment called QLS-111 for people with Normal Tension Glaucoma (NTG), a type of glaucoma where eye pressure is lower than usual but can still cause vision problems. The goal of the trial is to see if QLS-111 is safe and effective in lowering eye pressure in patients with NTG. The study is currently not recruiting participants, but when it starts, it will be open to adults aged 30 and older who have NTG in one or both eyes and can provide written consent to participate.

To be eligible for the trial, participants need to have a certain level of vision and specific eye pressure measurements. However, individuals with a history of certain eye conditions, previous surgeries for glaucoma, or significant health issues may not qualify. If you participate, you can expect to use the eyedrop and attend regular check-ups to monitor your eye pressure and overall health during the study. It's important to know that if you are pregnant, breastfeeding, or have certain other medical conditions, you won't be able to join this trial.

Gender

ALL

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 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