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Qlaris Phase 2 Study in NTG Patients

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ClinicalTrials.gov Identifier: NCT06030193
Recruitment Status : Not yet recruiting
First Posted : September 8, 2023
Last Update Posted : January 29, 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 normal tension glaucoma patients.

Condition or disease Intervention/treatment Phase
Normal Tension Glaucoma (NTG) Low-Tension Glaucoma, Bilateral Low-Tension Glaucoma, Unspecified Eye Glaucoma Drug: QLS-111 ophthalmic solution, (0.015%) Drug: QLS-111 ophthalmic solution, (0.03%) 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 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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 appearing packaging. Unmasked statistician preparing the masked randomization schedule.
Primary Purpose: Treatment
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)
Estimated Study Start Date : June 10, 2024
Estimated Primary Completion Date : February 17, 2025
Estimated Study Completion Date : March 7, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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Arm Intervention/treatment
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).
 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
Placebo Comparator: QLS-111 ophthalmic vehicle solution
Inactive control. 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: (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: dilated biomicroscopy of eye to observe clinically significant changes from baseline

  4. 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

  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 sign, measuring systolic and diastolic blood pressure

  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: 21 days ]
    Ocular hypotensive efficacy: IOP CFB for multiple timepoints throughout the day


Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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): NCT06030193


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

Locations
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Korea, Republic of
To be determined
Seoul, Korea, Republic of
Philippines
To be determined
Manila, Philippines
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: NCT06030193    
Other Study ID Numbers: QC-111-202
Nightingale ( Other Identifier: Qlaris Bio, Inc. )
First Posted: September 8, 2023    Key Record Dates
Last Update Posted: January 29, 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.:
NTG
Qlaris
intraocular pressure (IOP)
 Glaucoma
Nightingale
low-tension glaucoma
Additional relevant MeSH terms:
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Glaucoma
Low Tension Glaucoma
Ocular Hypertension
Eye Diseases
 Optic Nerve Diseases
Pharmaceutical Solutions
Ophthalmic Solutions