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Ophthalmology

Ophthalmology Clinical Research Capabilities

WCCT Global offers an end-to-end solution for conducting Phase I-II ophthalmic clinical trials. WCCT combines site ownership with a network of ophthalmology research centers, investigators, and KOLs to provide its partners the experience and services necessary to accelerate the development of new treatments. Since 2006, WCCT has performed over 40 clinical trials in the area of ophthalmology.

Clinical Development Highlights

Has served as a partner from Phase I through Phase III trials in the following indications:

  • Open-Angle Glaucoma
  • Ocular Hypertension
  • Dry Eye Disease
  • Corneal Disorders
  • Myopia
  • Presbyopia
  • Uveitis

WCCT maintains numerous partnerships with KOLs and key-collaborating research sites across the country. With 10 sites in southern CA and another 20+ sites throughout the U.S., WCCT brings together a breadth of ophthalmic specialists with access to a variety of patients and combines this with our depth of knowledge in early clinical development.

Additionally, WCCT’s Clinical Pharmacology Unit (CPU) is located near Los Angeles, CA, providing access to an ethnically diverse population of ophthalmology patients, particularly for early phase ethnobridging and proof of concept trials. WCCT’s 180-bed CPU in Cypress, CA is capable of conducting various ophthalmic procedures and assessments in-house including: BCVA, slit lamp examination, lens opacification, IOP measurement, gonioscopy, specular microscopy, and more.

 

Sample Experience List

Ophthalmology Case Study

Phase 2 Crossover, Diurnal IOP, Plasma PK, Safety and Ethnic Sensitivity Study

A Phase 2, Single-Masked, Randomized, Crossover Study Of The 24-Hour Intraocular Pressure (IOP) Lowering And Systemic Exposure Of *** Alone And In Combination With Latanoprost

Population: 32 Patients with glaucoma or ocular hypertension; 24 Caucasian, 8 Japanese

Enrollment Period : 45 days

Study Design:

  • Screening Period of up to 45 days prior to the dosing day
  • Eligibility Vist 3 to 28 days after the screening visit
  • Period 1:

• Two 24 hours inpatient visits for baseline and treatment IOP curveat WCCT Cypress CPU
• 8 outpatient visits (OPV) at ophthalmologist’s office
• Total 10 days of home dosing (self-administration)

  • 28 days washout from the last dosing of period 1
  • Period 2:

• Two 24 hours inpatient visits for baseline and treatment IOP curve at WCCT Cypress CPU
• 8 outpatient visits (OPV) at ophthalmologist’s office
• Total 10 days of home dosing (self-administration)

Ophthalmology Clinical Study Case Study-2020

Procedures Performed:

  • Manifest Refraction
  • BCVA
  • Visual Field
  • Hyperemia Assessment
  • Biomicroscopy
  • Corneal Staining
  • Ophthalmoscopy
  • Confocal Microscopy
  • Sitting and Supine IOP Measu rements
    (Serial – to compare baseline and on-treatment curves)
  • Gonioscopy
  • Pachymetry
  • Serial PK Blood Sampling

Challenges:

  • Added layer of Japanese ethnicity requirement to subset of patients, while maintaining
    IOP eligibility requirements for the Glaucoma or Ocular HTN criteria.
  • Robust data collection: diurnal IOP at Period 1 compared to Period 2; crossover PK and
    safety data collected; ethnic-sensitivity data collected.

Results:

  • Study conducted with two ophthalmology sites enrolling patients and centralized inpatient
    visits conducted at WCCT’s Cypress, CA CPU.
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