NCT06249152CompletedPhase 2
Qlaris Study of QLS-111 in Combination With a PGA for OAG and/or OHT Patients
A Pilot, Double-masked, Vehicle-controlled, Randomized Study to Evaluate the Safety and Tolerability of QLS-111 Versus Vehicle in Combination With Latanoprost Treatment in Subjects With Open-angle Glaucoma and/or Ocular Hypertension
Source: ClinicalTrials.gov · Last updated 20 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (actual)
- First submitted
- 31 Jan 2024
- Start date
- 21 Apr 2024
- Primary completion date
- 20 Dec 2024
- Lead sponsor
- Qlaris Bio, Inc.
- Diseases
- Glaucoma, High blood pressure
- NCT number
- NCT06249152
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 36
- From 21 Apr 2024 to the primary completion date, 20 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of other topical ocular medications with exception of the PGA which the patient will use throughout the study
- 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.
- Participation in any investigational study within 30 days prior to screening
Other illness
- History of active ocular disease other than mild to moderate OAG/OHT
- 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
Other
- Nonresponse to and/or noncompliant with PGA treatment
- Moderate to severe glaucomatous damage in either eye
- Pregnant or lactating
Who the study is looking for
- 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
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Berkeley Eye Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.