Qlaris Phase 2 Study of QLS-111 in POAG and/or OHT Patients

• ClinicalTrials.gov Identifier: NCT06016972
• Recruitment Status: Recruiting
• First Posted: August 30, 2023
• Last Update Posted: March 19, 2024
• Sponsor: Qlaris Bio, Inc.
• Information provided by (Responsible Party): Qlaris Bio, Inc.

Tracking Information

• First Submitted Date: August 18, 2023
• First Posted Date: August 30, 2023
• Last Update Posted Date: March 19, 2024
• Actual Study Start Date: March 15, 2024
• Estimated Primary Completion Date: September 5, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 29, 2023)

• Incidence of ocular symptoms and ocular treatment-emergent adverse events (TEAEs) [ Time Frame: 21 days ]
  Ocular safety and tolerability: adverse events (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: slit lamp
• Clinically significant change in findings on fundus exam [ Time Frame: 21 days ]
  Ocular safety and tolerability: fundus
• 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 signs
• 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: August 29, 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: up to 21 days ]
  Ocular hypotensive efficacy: CFB for multiple timepoints throughout 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 of QLS-111 in POAG and/or OHT Patients
• Official Title: A Randomized, Multi-site, Double-masked Study Evaluating the Safety and Tolerability of QLS-111 vs Vehicle in Primary Open-angle Glaucoma or Ocular Hypertension Patients
• Brief Summary: Qlaris' Phase 2 clinical trial investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in primary open-angle glaucoma (POAG) or ocular hypertension 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 primary open-angle glaucoma or ocular hypertension. Primary objective is to evaluate the ocular and systemic safety and tolerability of 3 concentrations of QLS-111 compared to vehicle control. Secondary objective is to evaluate the ocular hypotensive efficacy of 3 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 packaging. Unmasked statistician preparing the masked randomization schedule.

Primary Purpose: Treatment

Condition

• Primary Open Angle Glaucoma (POAG)
• Primary Open Angle Glaucoma of Both Eyes
• Primary Open-Angle Glaucoma, Unspecified Eye
• Ocular Hypertension (OHT)

Intervention

• Drug: Experimental: 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: Experimental: 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
• Drug: Experimental: QLS-111 ophthalmic solution, (0.075%)
  QLS-111 ophthalmic solution, (0.075%) 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 3 concentrations for this study (0.015%, 0.03%. and 0.075%), single use vials, masked, and preservative free (PF).
  Interventions:

  • Drug: Experimental: QLS-111 ophthalmic solution, (0.015%)
  • Drug: Experimental: QLS-111 ophthalmic solution, (0.03%)
  • Drug: Experimental: QLS-111 ophthalmic solution, (0.075%)
• Placebo Comparator: QLS-111 ophthalmic vehicle solution
  Inactive control (0.00%). QLS-111 ophthalmic vehicle solution, single use vials, masked, PF.
  Intervention: Other: QLS-111 ophthalmic vehicle solution

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 25, 2024): 60
• Original Estimated Enrollment (submitted: August 29, 2023): 120
• Estimated Study Completion Date: September 5, 2024
• Estimated Primary Completion Date: September 5, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 18 years or older
• Able to provide written acknowledgement of giving informed consent
• Best corrected visual acuity (BCVA) 20/200 or better Bilateral POAG or OHT with documented historic IOP value(s) ≥24 mmHg, in either eye
• Post-washout IOP ≥22 mmHg in morning on Visits 2 and 3 and ≥18 mmHg at noon on Visit 2

Exclusion Criteria:

• IOP >34 mmHg
• 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 year from study)
• Ocular trauma, ocular infections, ocular inflammation, herpes simplex keratitis of eye
• Use of other ophthalmic concomitant medications during the study
• 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: 18 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: United States

Administrative Information

• NCT Number: NCT06016972
• Other Study ID Numbers: QC-111-201; Osprey ( 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