Ocular Hypertension (OHT), Primary Open Angle Glaucoma of Both Eyes, Primary Open Angle Glaucoma (POAG), Primary Open-Angle Glaucoma, Unspecified Eye
Conditions
Keywords
Qlaris, POAG, OHT, IOP, Glaucoma, Osprey
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.
Interventions
DRUGExperimental: 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.
DRUGExperimental: 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.
DRUGExperimental: 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.
OTHERQLS-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.
Sponsors
Qlaris Bio, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinically significant changes in heart rate (HR) | 21 days | Systemic safety and tolerability: vital signs |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed