Qlaris Phase 2 Study in NTG Patients

• ClinicalTrials.gov Identifier: NCT06030193
• Recruitment Status: Not yet recruiting
• First Posted: September 8, 2023
• Last Update Posted: January 29, 2024
• Sponsor: Qlaris Bio, Inc.
• Information provided by (Responsible Party): Qlaris Bio, Inc.

Tracking Information

• First Submitted Date: August 18, 2023
• First Posted Date: September 8, 2023
• Last Update Posted Date: January 29, 2024
• Estimated Study Start Date: June 10, 2024
• Estimated Primary Completion Date: February 17, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 6, 2023)

• Incidence of ocular symptoms and ocular treatment-emergent adverse events (TEAEs) [ Time Frame: 21 days ]
  Ocular safety and tolerability: (AEs)
• Clinically significant change in visual acuity [ Time Frame: 21 days ]
  Ocular safety and tolerability: visual acuity
• Clinically significant change in findings on slit lamp exam [ Time Frame: 21 days ]
  Ocular safety and tolerability: dilated biomicroscopy of eye to observe clinically significant changes from baseline
• Clinically significant change in findings on fundus exam [ Time Frame: 21 days ]
  Ocular safety and tolerability: dilated ophthalmoscopy to observe clinically significant changes from baseline in posterior segment of eye
• Incidence of systemic TEAEs [ Time Frame: 21 days ]
  Systemic safety and tolerability: AEs
• Clinically significant changes in blood pressure (BP) [ Time Frame: 21 days ]
  Systemic safety and tolerability: vital sign, measuring systolic and diastolic blood pressure
• Clinically significant changes in heart rate (HR) [ Time Frame: 21 days ]
  Systemic safety and tolerability: vital signs

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 6, 2023)

• Change from baseline (CFB) of diurnal intraocular pressure (IOP) in the study eye [ Time Frame: 21 days ]
  Ocular hypotensive efficacy: diurnal IOP CFB
• CFB in IOP at various timepoints in the study eye [ Time Frame: 21 days ]
  Ocular hypotensive efficacy: IOP CFB for multiple timepoints throughout the day

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Qlaris Phase 2 Study in NTG Patients
• Official Title: A Randomized, Vehicle-controlled, Double-masked Study to Evaluate the Safety and Tolerability of QLS-111 Versus Vehicle in Subjects With Normal Tension Glaucoma (NTG)
• Brief Summary: Qlaris' Phase 2 clinical trial investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in normal tension glaucoma patients.

Detailed Description

A randomized, active- and vehicle-controlled, multi-site, double-masked study to evaluate the safety and tolerability of QLS-111 versus vehicle in subjects with NTG. Primary objective is to evaluate the ocular and systemic safety and tolerability of 2 concentrations of QLS-111 compared to vehicle control.

Secondary objective is to evaluate the ocular hypotensive efficacy of 2 concentrations of QLS-111 with once daily morning (QAM), once daily evening (QPM), and twice daily (BID) dosing versus vehicle with QAM, QPM, and BID dosing.

• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Multi site double masked, vehicle-controlled, randomized, prospective parallel study of 7 days' QAM dosing, followed by 7 days' QPM dosing, and 7 days' BID dosing (7 days of dosing per regimen [21-day treatment period])of an investigational product (IP), QLS-111 or vehicle. Both eyes (OU) will be dosed.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

Study subjects, Investigators and their staff, and Sponsor personnel involved with the conduct and monitoring of the study will be masked to the IP identity until after the final database is locked. IP will be provided in identical appearing packaging. Unmasked statistician preparing the masked randomization schedule.

Primary Purpose: Treatment

Condition

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

Intervention

• Drug: QLS-111 ophthalmic solution, (0.015%)
  QLS-111 ophthalmic solution, (0.015%) applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.
  Other Name: QLS-111
• Drug: QLS-111 ophthalmic solution, (0.03%)
  QLS-111 ophthalmic solution, (0.03%) applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.
  Other Name: QLS-111
• Other: QLS-111 ophthalmic vehicle solution
  Vehicle ophthalmic solution applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.
  Other Names:

  • Vehicle
  • Placebo

Study Arms

• Experimental: QLS-111 ophthalmic 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).
  Interventions:

  • Drug: QLS-111 ophthalmic solution, (0.015%)
  • Drug: QLS-111 ophthalmic solution, (0.03%)
• Placebo Comparator: QLS-111 ophthalmic vehicle solution
  Inactive control. QLS-111 ophthalmic vehicle solution, single use vials, masked, PF.
  Intervention: Other: QLS-111 ophthalmic vehicle solution

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: September 6, 2023): 120
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 7, 2025
• Estimated Primary Completion Date: February 17, 2025 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Lisa Brandano; 9789302103; lbrandano@qlaris.bio

Contact: Daniel DeWalt; ddewalt@qlaris.bio

• Listed Location Countries: Korea, Republic of, Philippines

Administrative Information

• NCT Number: NCT06030193
• Other Study ID Numbers: QC-111-202; Nightingale ( Other Identifier: Qlaris Bio, Inc. )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Qlaris Bio, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Qlaris Bio, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Lisa Brandano; Qlaris Bio, Inc.

• PRS Account: Qlaris Bio, Inc.
• Verification Date: August 2023