NCT06016972CompletedPhase 2
Qlaris Phase 2 Study of QLS-111 in POAG And/or OHT Patients
A Randomized, Multi-site, Double-masked Study Evaluating the Safety and Tolerability of QLS-111 Vs Vehicle in Primary Open-angle Glaucoma or Ocular Hypertension Patients
Source: ClinicalTrials.gov · Last updated 20 Jan 2025
Brief summary (registry, in English)
Qlaris' Phase 2 clinical trial investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in primary open-angle glaucoma (POAG) or ocular hypertension patients.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 63 (actual)
- First submitted
- 18 Aug 2023
- Start date
- 5 Mar 2024
- Primary completion date
- 20 Aug 2024
- Lead sponsor
- Qlaris Bio, Inc.
- Diseases
- Glaucoma, High blood pressure
- NCT number
- NCT06016972
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 63
- From 5 Mar 2024 to the primary completion date, 20 Aug 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
- Severe glaucomatous damage that would preclude safe washout of prescribed ocular hypotensive medications
- Previous glaucoma surgery, certain procedures (trabeculotomy, shunt/tubes, cyclodestructive procedure) (selective laser trabeculoplasty (SLT) allowed if done no earlier than 1 year from study, some minimally invasive glaucoma surgeries are allowed if done no earlier than 1 year from study)
- Use of other ophthalmic concomitant medications during the study
- Participation in other investigational trial 30 days prior to screening or previous enrollment and treatment with Qlaris investigational product
Other illness
- Ocular trauma, ocular infections, ocular inflammation, herpes simplex keratitis of eye
- Uncontrolled hypertension or hypotension
- Significant systemic or psychiatric disease
Other
- IOP \>34 mmHg
- Pregnant or lactating
Who the study is looking for
- 18 years or older
- Able to provide written acknowledgement of giving informed consent
- Best corrected visual acuity (BCVA) 20/200 or better Bilateral POAG or OHT with documented historic IOP value(s) ≥24 mmHg, in either eye
- Post-washout IOP ≥22 mmHg in morning on Visits 2 and 3 and ≥18 mmHg at noon on Visit 2
Age in the registry: 18 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 |
|---|---|---|---|
| Coastal Research Associates, LLC Coordinator of this site? Confirm its status | Roswell | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.