NCT06249152

Qlaris Study of QLS-111 in Combination With a PGA for OAG and/or OHT Patients

A Pilot, Double-masked, Vehicle-controlled, Randomized Study to Evaluate the Safety and Tolerability of QLS-111 Versus Vehicle in Combination With Latanoprost Treatment in Subjects With Open-angle Glaucoma and/or Ocular Hypertension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Qlaris Bio, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

Qlaris Phase 2 clinical study investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in combination with latanoprost in open-angle glaucoma (OAG) and/or ocular hypertension (OHT) patients.

Detailed description

Pilot, double-masked, vehicle-controlled, randomized, prospective parallel study of 14-day once daily evening (QPM) dosing, followed by 14-day twice daily (BID) dosing of an investigational product (IP), QLS-111, or vehicle as concomitant therapy with monotherapy latanoprost a PGA treatment that is administered QPM. Both eyes (OU) will be dosed. The study is comprised of seven (7) visits and approximately 28 days of IP dosing.

Conditions

• Open-angle Glaucoma (OAG)
• Ocular Hypertension (OHT)
• Glaucoma

Interventions

Type	Name	Description
DRUG	QLS-111, 0.015%	QLS-111 eyedrops applied QPM for 14 days the BID for 14 days.
DRUG	QLS-111, 0.030%	QLS-111 eyedrops applied QPM for 14 days the BID for 14 days.
DRUG	QLS-111, 0.075%	QLS-111 eyedrops applied QPM for 14 days the BID for 14 days.
DRUG	QLS-111 vehicle ophthalmic solution	Vehicle drops applied QPM for 14 days the BID for 14 days.

Timeline

• Start date: 2024-04-21
• Primary completion: 2024-12-20
• Completion: 2024-12-20
• First posted: 2024-02-08
• Last updated: 2025-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study