Glaucoma, Low-Tension Glaucoma, Bilateral, Low-Tension Glaucoma, Unspecified Eye, Normal Tension Glaucoma (NTG)
Conditions
Keywords
NTG, Qlaris, intraocular pressure (IOP), Glaucoma, Nightingale, low-tension glaucoma
Brief summary
Qlaris' Phase 2 clinical trial investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in normal tension glaucoma patients.
Detailed description
A randomized, active-controlled, multi-site, double-masked, pilot study to evaluate the safety and tolerability of QLS-111 0.015% versus Timolol maleate ophthalmic preservative free (PF) 0.5% ophthalmic solution in subjects with NTG. Primary objective is to evaluate the ocular and systemic safety and tolerability of QLS-111 0.015% compared to active control (Timolol). Secondary objective is to evaluate the ocular hypotensive efficacy of QLS-111 0.015% with once daily evening (QPM) and twice daily (BID) dosing versus Timolol with QPM dosing.
Interventions
QLS-111 ophthalmic solution 0.015% applied QPM OU for 7 days followed by BID dosing OU for 7 days, to constitute a 14-day study treatment period. All IP for this study will be supplied masked in PF single use vials.
DRUGTimolol Maleate PF 0.5% Ophthalmic Solution (Timolol)
Timolol BID: Timolol Maleate PF 0.5% Ophthalmic Solution (Timolol) with BID dosing OU will be administered up to 14 days. All IP for this study will be supplied masked in PF single use vials.
Sponsors
Qlaris Bio, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Study subjects, Investigators and their staff, and Sponsor personnel involved with the conduct and monitoring of the study will be masked to the IP identity until after the final database is locked. IP will be provided in identical appearing packaging. Unmasked statistician preparing the masked randomization schedule.
Intervention model description
Multi site double masked, active-controlled, randomized, prospective parallel, pilot study of 7 days' QPM dosing, followed by 7 days' BID dosing (7 days of dosing per regimen \[14-day treatment period\]) of an investigational product (IP), QLS-111 or Timolol. Both eyes (OU) will be dosed.
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 30 years or older * Able to provide written acknowledgement of giving informed consent * Best corrected visual acuity (BCVA) 20/200 or better * NTG in both eyes with untreated IOP \<21 mmHg at Visit 2 and morning assessment of Visit 3; IOP at morning assessment on Visits 2 and 3 doesn't differ more than 2 mmHg; has open iridocorneal angles, historic IOP \<22 mmHg in either eye
Exclusion criteria
* History of angle closure glaucoma, narrow or occludable angle on gonioscope * All secondary glaucomas * 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 1.5 years from study) * Ocular trauma, ocular infections, ocular inflammation, herpes simplex keratitis of eye * Use of other ophthalmic concomitant medications during the study * Refractive surgery * Uncontrolled hypertension or hypotension * Significant systemic or psychiatric disease * Participation in other investigational trial 30 days prior to screening or previous enrollment and treatment with Qlaris investigational product * Pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of ocular symptoms and ocular treatment-emergent adverse events (TEAEs) | 14 days | Ocular safety and tolerability: (AEs) |
| Clinically significant change in visual acuity | 14 days | Ocular safety and tolerability: visual acuity |
| Clinically significant change in findings on slit lamp exam | 14 days | Ocular safety and tolerability: dilated biomicroscopy of eye to observe clinically significant changes from baseline |
| Clinically significant change in findings on fundus exam | 14 days | Ocular safety and tolerability: dilated ophthalmoscopy to observe clinically significant changes from baseline in posterior segment of eye |
| Incidence of systemic TEAEs | 14 days | Systemic safety and tolerability: AEs |
| Clinically significant changes in blood pressure (BP) | 14 days | Systemic safety and tolerability: vital sign, measuring systolic and diastolic blood pressure |
| Clinically significant changes in heart rate (HR) | 14 days | Systemic safety and tolerability: vital signs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline (CFB) of diurnal intraocular pressure (IOP) in the study eye | 14 days | Ocular hypotensive efficacy: diurnal IOP CFB |
| CFB in IOP at various timepoints in the study eye | 14 days | Ocular hypotensive efficacy: IOP CFB for multiple timepoints throughout the day |
Countries
South Korea
Contacts
STUDY_DIRECTORLisa Brandano
Qlaris Bio, Inc.
Outcome results
None listed