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).
14-day prospective, double-masked, active-controlled, randomized multicenter study comparing QLS-111-FDC and PF latanoprost. Study is comprised of 5 visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
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.
Shettle Eye Research
Largo, Florida, United States
RECRUITINGChange from baseline in IOP
Change from baseline in IOP, lowering of IOP compared to baseline is desirable outcome.
Time frame: Over 15 days
Ocular safety and tolerability
Incidence of ocular adverse events
Time frame: Over 15 days
Ocular comfort
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.
Time frame: Over 15 days
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