Qlaris Study of QLS-111 in Combination With a PGA for OAG and/or OHT Patients

Korábbi kezelés

• 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

Más betegség

• 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

Egyéb

• Nonresponse to and/or noncompliant with PGA treatment
• Moderate to severe glaucomatous damage in either eye
• Pregnant or lactating

• 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