A Study to Evaluate Safety and Tolerability of QLS-101 in NTG

Study Overview
=================
Brief Summary
-----------------
A randomized active-controlled multi-site double-masked 28 day study to evaluate the safety and tolerability of QLS-101 versus timolol maleate Preservative Free (PF) 0.5% ophthalmic solution in subjects with normal tension glaucoma

Official Title
-----------------
A Randomized Active-controlled Study to Evaluate Safety and Tolerability of QLS-101 Versus Timolol Preservative Free (PF) Ophthalmic Solution in Subjects With Normal Tension Glaucoma (NTG)

Conditions
-----------------
Normal Tension Glaucoma (NTG)

Intervention / Treatment
-----------------
* Drug: QLS-101
* Drug: Timolol maleate PF 0.5% ophthalmic solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Visual acuity +1.0 logMAR or better Willing to give informed consent Ability to washout from current intraocular pressure lowering medications - Exclusion Criteria: All secondary glaucomas Previous glaucoma intraocular or laser surgery (selective laser trabeculoplasty permitted when done 18 months or longer from Screening) Refractive surgery Ocular infection or inflammation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QLS-101 ophthalmic solution 1.0%<br>Ophthalmic solution once daily (QD) dosing in both eyes (OU) for 14 days followed by 14 days of twice daily (BID) dosing. | Drug: QLS-101<br>* Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing.<br>* Other names: QLS-101 ophthalmic solution;|
| Active Comparator: Timolol maleate PF 0.5% ophthalmic solution<br>Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing. | Drug: Timolol maleate PF 0.5% ophthalmic solution<br>* Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing.<br>* Other names: Timolol;|
| Experimental: QLS-101 ophthalmic solution 2.0%<br>Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing. | Drug: QLS-101<br>* Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing.<br>* Other names: QLS-101 ophthalmic solution;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular safety | Number of participants with treatment-related adverse events will be monitored | 86 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular hypotensive efficacy | Number of participants with intraocular pressure reduction from baseline will be calculated | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low tension glaucoma (LTG), glaucoma