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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02129673
Recruitment Status : Completed
First Posted : May 2, 2014
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
ViSci Ltd.

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

Condition or disease Intervention/treatment Phase
Open Angle Glaucoma Ocular Hypertension Drug: VS101 Insert Dose A Drug: VS101 Insert Dose B Drug: VS101 Insert Dose C Drug: Latanoprost 0.005% eye drops Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2014
Actual Primary Completion Date : May 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Latanoprost

Arm Intervention/treatment
Experimental: VS101 Insert Dose A
VS101 Insert Dose A placed under the conjunctiva
Drug: VS101 Insert Dose A
Sustained release of latanoprost into the eye

Experimental: VS101 Insert Dose B
VS101 Insert Dose B placed under the conjunctiva
Drug: VS101 Insert Dose B
Sustained release of latanoprost into the eye

Experimental: VS101 Insert Dose C
VS101 Insert Dose C placed under the conjunctiva
Drug: VS101 Insert Dose C
Sustained release of latanoprost into the eye

Active Comparator: Latanoprost 0.005% eye drops
Latanoprost 0.005% eye drops administered once daily on the eye
Drug: Latanoprost 0.005% eye drops
Latanoprost 0.005% eye drops administered once daily on the eye




Primary Outcome Measures :
  1. Intra-ocular pressure [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Intra-ocular pressure [ Time Frame: Week 8 ]
  2. Intra-ocular pressure [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18
  • Open angle glaucoma or Ocular Hypertension

Exclusion Criteria:

  • uncontrolled medical conditions
  • wearing of contact lenses

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129673


Locations
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United States, Washington
Speciality Eyecare Centre
Bellevue, Washington, United States
Sponsors and Collaborators
ViSci Ltd.

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Responsible Party: ViSci Ltd.
ClinicalTrials.gov Identifier: NCT02129673     History of Changes
Other Study ID Numbers: VS101-CS201
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: October 2017

Keywords provided by ViSci Ltd.:
Glaucoma
Intra-ocular pressure
Slow Release
Controlled release

Additional relevant MeSH terms:
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Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Ophthalmic Solutions
Latanoprost
Pharmaceutical Solutions
Antihypertensive Agents