Qlaris Study of QLS-111 in Combination With a PGA for OAG and/or OHT Patients
NCT ID: NCT06249152
Last Updated: 2025-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
36 participants
INTERVENTIONAL
2024-04-21
2024-12-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Experimental: QLS-111 ophthalmic solution
Qlaris' IP, QLS-111 ophthalmic solution, provided in 3 concentrations (0.015%, 0.03%, and 0.075%), preservative free (PF), single-use units, masked.
QLS-111, 0.015%
QLS-111 eyedrops applied QPM for 14 days the BID for 14 days.
QLS-111, 0.030%
QLS-111 eyedrops applied QPM for 14 days the BID for 14 days.
QLS-111, 0.075%
QLS-111 eyedrops applied QPM for 14 days the BID for 14 days.
Placebo comparator: Vehicle ophthalmic solution
Inactive control (0.00%), PF, single-use units, masked.
QLS-111 vehicle ophthalmic solution
Vehicle drops applied QPM for 14 days the BID for 14 days.
Interventions
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QLS-111, 0.015%
QLS-111 eyedrops applied QPM for 14 days the BID for 14 days.
QLS-111, 0.030%
QLS-111 eyedrops applied QPM for 14 days the BID for 14 days.
QLS-111, 0.075%
QLS-111 eyedrops applied QPM for 14 days the BID for 14 days.
QLS-111 vehicle ophthalmic solution
Vehicle drops applied QPM for 14 days the BID for 14 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able and willing provide signed informed consent (assent)
* mild to moderate OAG or OHT in at least one eye and current or previous treatment with PGA. Exhibits decrease (i.e., \>20% from reported pre- treatment) in intraocular pressure (IOP). Patient is willing to continue latanoprost throughout the study.
* IOP ≥19 mmHg at 08:00 hour (H) at qualification visits prior to randomization
Exclusion Criteria
* Nonresponse to and/or noncompliant with PGA treatment
* Use of other topical ocular medications with exception of the PGA which the patient will use throughout the study
* Moderate to severe glaucomatous damage in either eye
* Previous glaucoma intraocular surgery in either eye (e.g., trabeculectomy, tubes, cyclodestructive procedures, diode) with exception of selective laser trabeculoplasty (SLT) if done less than 12 months from screening, trabecular meshwork minimally invasive glaucoma surgery (MIGS) when combined with cataract surgery and done less than 12 months from screening.
* significant ocular trauma, or intraocular surgery (e.g., cataract extraction/intraocular lens insertion) or extensive retinal laser treatment, refractive surgery in either eye.
* Ocular infection, inflammation (e.g., uveitis), moderate to severe blepharitis/meibomitis and/or severe keratoconjunctivitis sicca in either eye at screening, history of herpes simplex keratitis, in either eye.
* Clinically significant retinal disease in either eye
* Clinically significant systemic or psychiatric disease
* Participation in any investigational study within 30 days prior to screening
* Pregnant or lactating
12 Years
ALL
No
Sponsors
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Qlaris Bio, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Lisa Brandano
Role: STUDY_DIRECTOR
Qlaris Bio, Inc.
Locations
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Berkeley Eye Center
Houston, Texas, United States
Countries
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Related Links
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Company website, pipeline
Other Identifiers
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Apteryx
Identifier Type: OTHER
Identifier Source: secondary_id
QC-111-203
Identifier Type: -
Identifier Source: org_study_id
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