Study to Evaluate QLS-101 Compared to Timolol Maleate Eye Drops in Subjects With High Eye Pressure (Glaucoma or Ocular Hypertension).

Qlaris Bio

Status and phase: Completed; Phase 2

Conditions: Ocular Hypertension; Primary Open Angle Glaucoma

Treatments: Drug: Timolol Maleate; Drug: QLS-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT04830397

QC-201

Details and patient eligibility

About

Evaluating the safety and tolerability of QLS-101 versus timolol maleate ophthalmic solution in glaucoma or ocular hypertension.

Full description

Multi-site study to evaluate the safety and tolerability of 3 concentrations of QLS-101 versus timolol maleate Preservative Free (PF) 0.5% ophthalmic solution in subjects with primary open-angle glaucoma or ocular hypertension

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Visual acuity +1.0 logMAR or better
2. Willing to give informed consent
3. Ability to washout from current intraocular pressure lowering medications -

Exclusion criteria

1. Severe glaucomatous damage
2. Previous glaucoma intraocular or laser surgery
3. Refractive surgery
4. Ocular infection or inflammation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

84 participants in 4 patient groups

QLS-101 0.5%

Experimental group

Treatment:

Drug: QLS-101

QLS-101 1%

Experimental group

Treatment:

Drug: QLS-101

QLS-101 2%

Experimental group

Treatment:

Drug: QLS-101

Timolol Maleate 0.5% preservative free ophthalmic solution

Active Comparator group

Treatment:

Drug: Timolol Maleate