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Completed

NCT Number: NCT00596583

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bhagwan Mahaveer Jain Hospital, Bangalore, Karnataka, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have a cataract sufficiently opaque/mature/brunescent that, in the surgeon's assessment,a dye could facilitate surgery;
  • Be aged at least 18 years old at the time of enrollment;
  • Be able to tolerate a surgical procedure for up to 3 hours;
  • Be in a medical condition suitable for cataract surgery;
  • Able and willing to participate in study examinations and visit schedule; and
  • Understand and freely consent to participate in the study.

Exclusion criteria

  • In either eye, ocular infection or inflammation within the past 3 months;
  • Known allergy to BBG 250;
  • Uncontrolled intercurrent diseases including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia;
  • Active treatment for cancer or systemic infection within the past month;
  • Active treatment with systemic corticosteroids within the past month;
  • Previous participation in this Study for the contralateral eye;
  • Participation in another clinical trial involving an investigational therapeutic during the past 30 days or 5.5 half-lives (if applicable), whichever is longer;
  • Unwillingness to participate in the study or inability to give informed consent; or
  • Any medical condition that in the opinion of the Investigator may compromise the research subject's safety or ability to participate in the study.

Treatment and study plan

DYME

Drug

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

Primary outcomes

  1. Optimal curvilinear capsulorrhexis with a single dose, as assessed by the surgeon based on the tissue dyed and subsequently removed.

    Time frame: During surgery

  2. Uncomplicated discharge

    Time frame: one week post-op

Secondary outcomes

  1. Quality of stain

    Time frame: during surgery

  2. Intra-ocular safety of DYME as measured by best corrected visual acuity, corneal endothelial cell count, intraocular pressure, presence/absence of retained dye, duration of surgery, and the absence of dye related adverse events

    Time frame: 1-day and 1-week post-op

Sponsors and collaborators

Lead sponsor

Aqumen Biopharmaceuticals, N.A.

Industry

Registry information

Official study title

AQNA-DY001: A Double-Masked, Randomized Study of the Safety and Effectiveness of DYME as an Agent for Selective Staining of the Anterior Capsule During Cataract Surgery

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 17, 2008
Registry last updated
Mar 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.