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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06016972
Recruitment Status : Recruiting
First Posted : August 30, 2023
Last Update Posted : March 19, 2024
Sponsor:
Information provided by (Responsible Party):
Qlaris Bio, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Primary Open Angle Glaucoma (POAG) Primary Open Angle Glaucoma of Both Eyes Primary Open-Angle Glaucoma, Unspecified Eye Ocular Hypertension (OHT) Drug: Experimental: QLS-111 ophthalmic solution, (0.015%) Drug: Experimental: QLS-111 ophthalmic solution, (0.03%) Drug: Experimental: QLS-111 ophthalmic solution, (0.075%) Other: QLS-111 ophthalmic vehicle solution Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
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
Actual Study Start Date : March 15, 2024
Estimated Primary Completion Date : September 5, 2024
Estimated Study Completion Date : September 5, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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).
 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
Placebo Comparator: QLS-111 ophthalmic vehicle solution
Inactive control (0.00%). QLS-111 ophthalmic vehicle solution, single use vials, masked, PF.
 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


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of ocular symptoms and ocular treatment-emergent adverse events (TEAEs) [ Time Frame: 21 days ]
    Ocular safety and tolerability: adverse events (AEs)

  2. Clinically significant change in visual acuity [ Time Frame: 21 days ]
    Ocular safety and tolerability: visual acuity

  3. Clinically significant change in findings on slit lamp exam [ Time Frame: 21 days ]
    Ocular safety and tolerability: slit lamp

  4. Clinically significant change in findings on fundus exam [ Time Frame: 21 days ]
    Ocular safety and tolerability: fundus

  5. Incidence of systemic TEAEs [ Time Frame: 21 days ]
    Systemic safety and tolerability: AEs

  6. Clinically significant changes in blood pressure (BP) [ Time Frame: 21 days ]
    Systemic safety and tolerability: vital signs

  7. Clinically significant changes in heart rate (HR) [ Time Frame: 21 days ]
    Systemic safety and tolerability: vital signs


Secondary Outcome Measures :
  1. Change from baseline (CFB) of diurnal intraocular pressure (IOP) in the study eye [ Time Frame: 21 days ]
    Ocular hypotensive efficacy: diurnal IOP CFB

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06016972


Contacts
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Contact: Lisa Brandano 9789302103 lbrandano@qlaris.bio
Contact: Daniel DeWalt ddewalt@qlaris.bio

Locations
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United States, Georgia
Coastal Research Associates, LLC Recruiting
Roswell, Georgia, United States, 30076
Sponsors and Collaborators
Qlaris Bio, Inc.
Investigators
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Study Director: Lisa Brandano Qlaris Bio, Inc.
More Information
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Additional Information:

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Responsible Party: Qlaris Bio, Inc.
ClinicalTrials.gov Identifier: NCT06016972    
Other Study ID Numbers: QC-111-201
Osprey ( Other Identifier: Qlaris Bio, Inc. )
First Posted: August 30, 2023    Key Record Dates
Last Update Posted: March 19, 2024
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Qlaris Bio, Inc.:
Qlaris
POAG
OHT
 IOP
Glaucoma
Osprey
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions