OAG - Open-Angle Glaucoma, OHT - Ocular Hypertension
Conditions
Keywords
glaucoma, intraocular pressure (IOP), eye drops
Brief summary
Firecrest study is evaluating the intraocular pressure (IOP)-lowering effect, safety, and tolerability of Qlaris' preservative free \[PF\], fixed-dose combination \[FDC\] investigational product (IP) in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).
Detailed description
14-day prospective, double-masked, active-controlled, randomized multicenter study comparing QLS-111-FDC and PF latanoprost. Study is comprised of 5 visits.
Interventions
COMBINATION_PRODUCTQLS-111-FDC
QLS-111-FDC, a PF FDC administered by topical ophthalmic (TO) application for 14 days in the evening (QPM) in both eyes (OU).
PF latanoprost administered by TO application for 14 days QPM OU.
Sponsors
Qlaris Bio, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
IP is packaged and labeled in a masked fashion
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* BCVA 1.0 logMAR or better in each eye (equivalent to 20/200) * Diagnosis of mild to moderate OAG or OHT in at least one eye * IOP ≥19 mmHg at 08:00 hour (H) at Qualification Visits following a run-in with PF latanoprost
Exclusion criteria
* History of active ocular disease other than mild to moderate OAG/OHT * Prior use of any topical PGA without a clinically meaningful response * Noncompliant with current ocular anti-hypertensive medications or unwilling to be compliant throughout the study * Use of other topical ocular concomitant medications 30 days prior * History of angle closure or a narrow angle, significant ocular trauma, ocular infection, uveitis, intraocular surgery in either eye. * Central corneal thickness in either eye \<470 or \>630 μm * Clinically significant systemic or psychiatric disease, chronic kidney disease, or hypertension, hypotension, or diabetes that is uncontrolled. * Participation in any investigational study within 30 days prior to Screening * Females who are pregnant, nursing, or not using birth control.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in IOP | Over 15 days | Change from baseline in IOP, lowering of IOP compared to baseline is desirable outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ocular safety and tolerability | Over 15 days | Incidence of ocular adverse events |
| Ocular comfort | Over 15 days | Ocular comfort following study treatment as assessed by subject and using a visual analog scale (VAS) provided by the site at the treatment period visits. Subjects will grade their ocular comfort on a scale of 0 (extremely comfortable) to 100 (extremely uncomfortable) by placing a vertical mark on the horizontal line. |
Countries
United States
Contacts
STUDY_DIRECTORBarbara M Wirostko, MD
Qlaris Bio, Inc.
Outcome results
None listed