A Phase 1/2 Multicenter, Randomized, Study to Evaluate the Safety and Efficacy of VS101 Subconjunctival Latanoprost Insert in Subjects With Open-Angle Glaucoma or Ocular Hypertension

ViSci Ltd.

Status and phase: Completed; Phase 2; Phase 1

Conditions: Open Angle Glaucoma; Ocular Hypertension

Treatments: Drug: VS101 Insert Dose C; Drug: Latanoprost 0.005% eye drops; Drug: VS101 Insert Dose A; Drug: VS101 Insert Dose B

Study type: Interventional

Funder types: Industry

Identifiers

NCT02129673

VS101-CS201

Details and patient eligibility

About

Slow release formulation of latanoprost is compared for safety and pressure-lowering efficacy with topically administration of commercially available latanoprost in patient with glaucoma and ocular hypertension

Enrollment: 77 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18
• Open angle glaucoma or Ocular Hypertension

Exclusion criteria

• uncontrolled medical conditions
• wearing of contact lenses

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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77 participants in 4 patient groups

VS101 Insert Dose A

Experimental group

Description:

VS101 Insert Dose A placed under the conjunctiva

Treatment:

Drug: VS101 Insert Dose A

VS101 Insert Dose B

Experimental group

Description:

VS101 Insert Dose B placed under the conjunctiva

Treatment:

Drug: VS101 Insert Dose B

VS101 Insert Dose C

Experimental group

Description:

VS101 Insert Dose C placed under the conjunctiva

Treatment:

Drug: VS101 Insert Dose C

Latanoprost 0.005% eye drops

Active Comparator group

Description:

Latanoprost 0.005% eye drops administered once daily on the eye

Treatment:

Drug: Latanoprost 0.005% eye drops