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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

A Phase 1/2 Multicenter, Randomized, Controlled Dose-Finding Study to Evaluate the Safety and Ocular Hypotensive Efficacy of 3 Dose Levels of the VS101 Subconjunctival Latanoprost Insert for 3 Months in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02129673
Enrollment
77
Registered
2014-05-02
Start date
2014-05-31
Completion date
2017-08-31
Last updated
2018-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open Angle Glaucoma, Ocular Hypertension

Keywords

Glaucoma, Intra-ocular pressure, Slow Release, Controlled release

Brief summary

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

Interventions

DRUGVS101 Insert Dose A

Sustained release of latanoprost into the eye

DRUGVS101 Insert Dose B

Sustained release of latanoprost into the eye

DRUGVS101 Insert Dose C

Sustained release of latanoprost into the eye

DRUGLatanoprost 0.005% eye drops

Latanoprost 0.005% eye drops administered once daily on the eye

Sponsors

ViSci Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Age \> 18 * Open angle glaucoma or Ocular Hypertension

Exclusion criteria

* uncontrolled medical conditions * wearing of contact lenses

Design outcomes

Primary

MeasureTime frame
Intra-ocular pressure12 weeks

Secondary

MeasureTime frame
Intra-ocular pressureWeek 8

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026