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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06249152
• Other study ID #: QC-111-203
• Secondary ID: Apteryx I
• Status: Recruiting
• Phase: Phase 2
• Start date: April 21, 2024
• Est. completion date: October 5, 2024

Study information

• Verified date: January 2024
• Source: Qlaris Bio, Inc.
• Contact: Lisa Brandano
• Phone: 9789302103
• Email: lbrandano[@]qlaris.bio
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Pilot, double-masked, vehicle-controlled, randomized, prospective parallel study of 14-day once daily evening (QPM) dosing, followed by 14-day twice daily (BID) dosing of an investigational product (IP), QLS-111, or vehicle as concomitant therapy with monotherapy latanoprost a PGA treatment that is administered QPM. Both eyes (OU) will be dosed. The study is comprised of seven (7) visits and approximately 28 days of IP dosing.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: October 5, 2024
• Est. primary completion date: October 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• History of active ocular disease other than mild to moderate OAG/OHT
• Nonresponse to and/or noncompliant with PGA treatment
• Use of other topical ocular medications with exception of the PGA which the patient will use throughout the study
• Moderate to severe glaucomatous damage in either eye
• 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.
• 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
• Participation in any investigational study within 30 days prior to screening
• Pregnant or lactating

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Ocular Hypertension (OHT)
• Open-angle Glaucoma (OAG)

Intervention

Drug:
• QLS-111, 0.015%
QLS-111 eyedrops applied QPM for 14 days the BID for 14 days.
• QLS-111, 0.030%
QLS-111 eyedrops applied QPM for 14 days the BID for 14 days.
• QLS-111, 0.075%
QLS-111 eyedrops applied QPM for 14 days the BID for 14 days.
• QLS-111 vehicle ophthalmic solution
Vehicle drops applied QPM for 14 days the BID for 14 days.

Locations

Country	Name	City	State
United States	Berkeley Eye Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Qlaris Bio, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of ocular treatment-emergent adverse events (TEAEs)	Ocular safety and tolerability	28 days
Primary	Clinically significant change in visual acuity	Ocular safety and tolerability	28 days
Primary	Clinically significant change in findings on slit lamp exam	Ocular safety and tolerability	28 days
Primary	Clinically significant change in findings on fundus exam	Ocular safety and tolerability	28 days
Primary	Incidence of systemic (TEAEs)	Systemic safety and tolerability	28 days
Primary	Clinically significant change in blood pressure	Systemic safety and tolerability	28 days
Primary	Clinically significant change in heart rate	Systemic safety and tolerability	28 days
Secondary	Change from baseline (CFB) of mean diurnal IOP in the study eye	Ocular hypotensive efficacy: diurnal IOP	28 days
Secondary	CFB in IOP at various timepoints in the study eye	Ocular hypotensive efficacy: CFB for multiple timepoints	28 days

External Links

•   Company website, pipeline