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Safety and IOP-Lowering Effects of WB007

Sponsor
Whitecap Biosciences, LLC (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04149899
Collaborator
(none)
77
Enrollment
1
Location
4
Arms
24.6
Anticipated Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the safety and IOP-lowering effects of WB007 in adults with primary open-angle glaucoma or ocular hypertension in both eyes. This is a 2-part study. Part 1 will look at up to 3 formulations of WB007 ophthalmic solution following a single dose in one eye. Part 2 will look at up to 2 formulations of WB007 (to be selected based on results from Part 1) in both eyes compared with timolol 0.5% for 14 days.

Condition or Disease Intervention/Treatment Phase
  • Drug: Study Treatment 1 WB007
  • Drug: Study Treatment 2 WB007
  • Drug: Study Treatment 3 WB007
  • Drug: Timolol 0.5%
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
77 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Part 1 - Open-labelled, single dose, Dose escalation; Part 2 - Double-masked, randomized, parallel comparisonPart 1 - Open-labelled, single dose, Dose escalation; Part 2 - Double-masked, randomized, parallel comparison
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Part 1 - not masked; Part 2 - Double-masked - neither investigator, study staff nor study participant will be aware of treatment assignment
Primary Purpose:
Treatment
Official Title:
A Phase 1/2a Assessment of WB007 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension
Actual Study Start Date :
Nov 14, 2019
Actual Primary Completion Date :
Jan 31, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study Treatment 1

WB007 Formulation 1

Drug: Study Treatment 1 WB007
Dosed for 14 days in both eyes
Other Names:
  • WB007 Formulation 1

    		•
    Experimental: Study Treatment 2

    WB007 Formulation 2

    Drug: Study Treatment 2 WB007
    Dosed for 14 days in both eyes
    Other Names:
  • WB007 Formulation 2

    		•
    Experimental: Study Treatment 3

    WB007 Formulation 3

    Drug: Study Treatment 3 WB007
    Dosed for 14 days in both eyes
    Other Names:
  • WB007 Formulation 3

    		•
    Active Comparator: Timolol 0.5%

    Timolol maleate ophthalmic solution, 0.5%

    Drug: Timolol 0.5%
    Dosed for 14 days in both eyes
    Other Names:
  • timolol maleate ophthalmic solution 0.5%

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mean change from Baseline in intraocular pressure (IOP) at Day 14 [Baseline, Day 14]

      IOP measured by Goldmann applanation tonometry

    Secondary Outcome Measures

    1. Mean IOP at Day 14 [Baseline, Day 14]

      IOP measured by Goldmann applanation tonometry

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Ocular hypertension or primary open-angle glaucoma in each eye
    Exclusion Criteria:

    • History of orthostatic hypotension

    • Any active ocular disease

    • Anticipated wearing of contact lenses during study

    • Contraindication to pupil dilatation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Eye Research Foundation Newport Beach California United States 92663

    Sponsors and Collaborators

    • Whitecap Biosciences, LLC

    Investigators

    • Principal Investigator: David Wirta, MD, Eye Research Foundation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Whitecap Biosciences, LLC
    ClinicalTrials.gov Identifier:
    NCT04149899
    Other Study ID Numbers:
    • WB007-001
    First Posted:
    Nov 4, 2019
    Last Update Posted:
    Oct 12, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Whitecap Biosciences, LLC
    POAG
    OHT
    Primary open-angle glaucoma
    ocular hypertension
    Additional relevant MeSH terms:
    Glaucoma
    Ocular Hypertension
    Glaucoma, Open-Angle
    Hypertension
    Timolol
    Ophthalmic Solutions

    Study Results

    No Results Posted as of Oct 12, 2021