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

Qlaris Bio

Status and phase: Completed; Phase 2

Conditions: Normal Tension Glaucoma (NTG)

Treatments: Drug: QLS-101; Drug: Timolol maleate PF 0.5% ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT04857827

QC-202

Details and patient eligibility

About

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

Enrollment: 30 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. All secondary glaucomas
2. Previous glaucoma intraocular or laser surgery (selective laser trabeculoplasty permitted when done 18 months or longer from Screening)
3. Refractive surgery
4. Ocular infection or inflammation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 3 patient groups

QLS-101 ophthalmic solution 1.0%

Experimental group

Description:

Ophthalmic solution once daily (QD) dosing in both eyes (OU) for 14 days followed by 14 days of twice daily (BID) dosing.

Treatment:

Drug: QLS-101

Timolol maleate PF 0.5% ophthalmic solution

Active Comparator group

Description:

Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing.

Treatment:

Drug: Timolol maleate PF 0.5% ophthalmic solution

QLS-101 ophthalmic solution 2.0%

Experimental group

Description:

Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing.

Treatment:

Drug: QLS-101