Qlaris Phase 2 Study of QLS-111 in POAG and/or OHT Patients
Study Details
Study Description
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 |
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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 timolol maleate Preservative Free 0.5% ophthalmic solution and 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 timolol maleate PF 0.5% ophthalmic solution and 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 timolol maleate PF 0.5% ophthalmic solution and vehicle with QAM, QPM, and BID dosing.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: QLS-111 ophthalmic solution Qlaris' investigational product, QLS-111 ophthalmic solution, provided in 3 concentrations for this study (0.15%, 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 Names:
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 Names:
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 Names:
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Active Comparator: Timolol maleate Preservative Free 0.5% ophthalmic solution Active control. Timolol maleate Preservative Free 0.5% ophthalmic solution, single use vials, masked, PF. |
Drug: Timolol maleate Preservative Free 0.5% ophthalmic solution
Timolol 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:
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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:
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Outcome Measures
Primary Outcome Measures
- Incidence of ocular symptoms and ocular treatment-emergent adverse events (TEAEs) [21 days]
Ocular safety and tolerability: adverse events (AEs)
- Clinically significant change in visual acuity [21 days]
Ocular safety and tolerability: visual acuity
- Clinically significant change in findings on slit lamp exam [21 days]
Ocular safety and tolerability: slit lamp
- Clinically significant change in findings on fundus exam [21 days]
Ocular safety and tolerability: fundus
- Incidence of systemic TEAEs [21 days]
Systemic safety and tolerability: AEs
- Clinically significant changes in blood pressure (BP) [21 days]
Systemic safety and tolerability: vital signs
- Clinically significant changes in heart rate (HR) [21 days]
Systemic safety and tolerability: vital signs
Secondary Outcome Measures
- Change from baseline (CFB) of diurnal intraocular pressure (IOP) in the study eye [21 days]
Ocular hypotensive efficacy: diurnal IOP CFB
- CFB in IOP at various timepoints in the study eye [up to 21 days]
Ocular hypotensive efficacy: CFB for multiple timepoints throughout day
Eligibility Criteria
Criteria
Inclusion Criteria:
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12 years or older
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Able to provide written acknowledgement of giving informed consent
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Best corrected visual acuity (BCVA) 20/200 or better Bilateral POAG or OHT with documented historic IOP value(s) ≥24 mmHg, in either eye
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Post-washout IOP ≥22 mmHg in morning on Visits 2 and 3 and ≥18 mmHg at noon on Visit 2
Exclusion Criteria:
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IOP >34 mmHg
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Severe glaucomatous damage that would preclude safe washout of prescribed ocular hypotensive medications
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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)
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Ocular trauma, ocular infections, ocular inflammation, herpes simplex keratitis of eye
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Use of other ophthalmic concomitant medications during the study
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Known hypersensitivity to Timolol
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Uncontrolled hypertension or hypotension
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Significant systemic or psychiatric disease
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Participation in other investigational trial 30 days prior to screening or previous enrollment and treatment with Qlaris investigational product
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Pregnant or lactating
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Qlaris Bio, Inc.
Investigators
- Study Director: Lisa Brandano, Qlaris Bio, Inc.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- QC-111-201