Shettle Eye Research
Largo, Florida, 33773, United States
NCT Number: NCT07354516
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).
This study is active but is not currently recruiting participants.
Notify Me12 year and older
All sexes
Interventional
Phase 2 / Phase 3
Largo, Florida, 33773, United States
14-day prospective, double-masked, active-controlled, randomized multicenter study comparing QLS-111-FDC and PF latanoprost. Study is comprised of 5 visits.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: latanoprost ophthalmic solution 0.005%, PF
Time frame: Over 15 days
Change from baseline in IOP, lowering of IOP compared to baseline is desirable outcome.
Time frame: Over 15 days
Incidence of ocular adverse events
Time frame: 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.
Qlaris Bio, Inc.
Industry
A Masked, Randomized, Prospective Study of QLS-111-FDC in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Acronym: Firecrest
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03931317
Eye Diseases, Glaucoma
La Jolla, California, United States
View Trial DetailsNCT05696561
Eye Diseases, Glaucoma
Santiago, Chile
View Trial DetailsNCT05271734
Eye Diseases, Glaucoma
Tbilisi, Georgia
View Trial DetailsNCT04888156
Exfoliation Syndrome, Eye Diseases
Stockholm, Sweden
View Trial Details