MedTrace Logo

DY001: Safety and Effectiveness of DYME as an Agent for Selective Staining of the Anterior Capsule During Cataract Surgery

NCT00596583 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2009-03-02

No results posted yet for this study

Summary

The primary objective of this study is to test the hypothesis that DYME is safe and effective as a drug to facilitate continuous curvilinear capsulorhexis (CCC) by selectively staining the anterior capsule. Secondary objectives are to compare the safety and effectiveness of DYME to that of a smaller dose of the same API.

Conditions

  • Mature Cataracts

Interventions

DRUG

DYME

2ml of 0.25 mg/ml BBG 250 in sterile ophthalmic solution

DRUG

DYME

2ml of 0.05 mg/ml BBG 250 in sterile ophthalmic solution

Sponsors & Collaborators

  • Aqumen Biopharmaceuticals, N.A.

    lead INDUSTRY

Principal Investigators

  • Hardy Kagimoto, M.D. · Aqumen Biopharmaceuticals, N.A.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • United States
  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00596583 on ClinicalTrials.gov