Glaucoma, Ocular Hypertension (OHT), Open-angle Glaucoma (OAG)
Conditions
Keywords
Qlaris, OAG, Glaucoma, PGA therapy, Apteryx I, OHT, latanoprost
Brief summary
Qlaris Phase 2 clinical study investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in combination with latanoprost in open-angle glaucoma (OAG) and/or ocular hypertension (OHT) patients.
Detailed description
Pilot, double-masked, vehicle-controlled, randomized, prospective parallel study of 14-day once daily evening (QPM) dosing, followed by 14-day twice daily (BID) dosing of an investigational product (IP), QLS-111, or vehicle as concomitant therapy with monotherapy latanoprost a PGA treatment that is administered QPM. Both eyes (OU) will be dosed. The study is comprised of seven (7) visits and approximately 28 days of IP dosing.
Interventions
DRUGQLS-111, 0.015%
QLS-111 eyedrops applied QPM for 14 days the BID for 14 days.
DRUGQLS-111, 0.030%
QLS-111 eyedrops applied QPM for 14 days the BID for 14 days.
DRUGQLS-111, 0.075%
QLS-111 eyedrops applied QPM for 14 days the BID for 14 days.
DRUGQLS-111 vehicle ophthalmic solution
Vehicle drops applied QPM for 14 days the BID for 14 days.
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, study staff, Sponsor and designates involved in the conduct, monitoring and outcome evaluation of the study will be masked to IP assignment identity until final database lock is complete. IP will be provided in in identical packaging. Unmasked statistician will prepare the randomization schedule.
Intervention model description
Multi-site, double-masked, vehicle-controlled randomized prospective, parallel study of 14-day QPM dosing followed by 14-day BID dosing of QLS-111 (3 concentrations versus vehicle in combination with latanoprost. Dosing is OU.
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 12 years or older * 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
* History of active ocular disease other than mild to moderate OAG/OHT * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinically significant change in heart rate | 28 days | Systemic safety and tolerability |
| Incidence of systemic (TEAEs) | 28 days | Systemic safety and tolerability |
| Clinically significant change in blood pressure | 28 days | Systemic safety and tolerability |
| Incidence of ocular treatment-emergent adverse events (TEAEs) | 28 days | Ocular safety and tolerability |
| Clinically significant change in visual acuity | 28 days | Ocular safety and tolerability |
| Clinically significant change in findings on slit lamp exam | 28 days | Ocular safety and tolerability |
| Clinically significant change in findings on fundus exam | 28 days | Ocular safety and tolerability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CFB in IOP at various timepoints in the study eye | 28 days | Ocular hypotensive efficacy: CFB for multiple timepoints |
| Change from baseline (CFB) of mean diurnal IOP in the study eye | 28 days | Ocular hypotensive efficacy: diurnal IOP |
Countries
United States
Outcome results
None listed