NCT02129673

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

March 14, 2018

Status Verified

October 1, 2017

Enrollment Period

3 years

First QC Date

April 30, 2014

Last Update Submit

March 13, 2018

Conditions

Open Angle GlaucomaOcular Hypertension

Keywords

GlaucomaIntra-ocular pressureSlow ReleaseControlled release

Outcome Measures

Primary Outcomes (1)

  • Intra-ocular pressure

    12 weeks

Secondary Outcomes (2)

  • Intra-ocular pressure

    Week 8

  • Intra-ocular pressure

    4 weeks

Study Arms (4)

VS101 Insert Dose A

EXPERIMENTAL

VS101 Insert Dose A placed under the conjunctiva

Drug: VS101 Insert Dose A

VS101 Insert Dose B

EXPERIMENTAL

VS101 Insert Dose B placed under the conjunctiva

Drug: VS101 Insert Dose B

VS101 Insert Dose C

EXPERIMENTAL

VS101 Insert Dose C placed under the conjunctiva

Drug: VS101 Insert Dose C

Latanoprost 0.005% eye drops

ACTIVE COMPARATOR

Latanoprost 0.005% eye drops administered once daily on the eye

Drug: Latanoprost 0.005% eye drops

Interventions

VS101 Insert Dose ADRUG

Sustained release of latanoprost into the eye

VS101 Insert Dose A
VS101 Insert Dose BDRUG

Sustained release of latanoprost into the eye

VS101 Insert Dose B
VS101 Insert Dose CDRUG

Sustained release of latanoprost into the eye

VS101 Insert Dose C
Latanoprost 0.005% eye dropsDRUG

Latanoprost 0.005% eye drops administered once daily on the eye

Latanoprost 0.005% eye drops

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • uncontrolled medical conditions
  • wearing of contact lenses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Speciality Eyecare Centre

Bellevue, Washington, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular HypertensionGlaucoma

Interventions

LatanoprostOphthalmic Solutions

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2014

First Posted

May 2, 2014

Study Start

May 1, 2014

Primary Completion

May 1, 2017

Study Completion

August 1, 2017

Last Updated

March 14, 2018

Record last verified: 2017-10

Locations

US(1)