Single-site Pilot Study Evaluating the Effect of QLS-111 Ophthalmic Solution on Posterior Perfusion and Vessel Dilation

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorQlaris Bio, Inc.

About this trial

Pilot, single-site, prospective study of QLS-111 0.015 % in subjects with NPDR, OAG or NTG

Eligibility criteria

Qualifiers

Diagnosis of mild to moderate OAG, mild to moderate NTG, or stable NPDR in at least one eye.

Corrected visual acuity in each eye +1.0 logMAR or better by early treatment diabetic retinopathy study (ETDRS) in each eye (equivalent to 20/200).

Able and willing to give signed informed consent and follow study instructions.

Disqualifiers

History of active ocular disease other than mild to moderate OAG, mild to moderate NTG, or stable NPDR.

Patient is using more than 1 ocular hypotensive topical medication for intraocular pressure (IOP) control (prior MIGS and/or laser trabeculoplasty to control IOP is allowed if done at least 3 months from Screening (Visit 1).

Use of TO β-blockers (i.e. timolol) within 3 months prior to Screening.

Is noncompliant with current ocular anti-hypotensive medications and/or unwilling to be compliant throughout the study.

Trial design

Treatments tested in this trial

  • QLS-111 Ophthalmic Solution (0.015%)
  • QLS-111 Ophthalmic Solution (0.075%)

Treatment groups

14 Participants
are divided into 1 treatment group

Sponsors and collaborators