Mature CataractsPhase 3NCT00596583
DY001: Safety and Effectiveness of DYME as an Agent for Selective Staining of the Anterior Capsule During Cataract Surgery
A Phase 3 study testing DYME in people with Mature Cataracts, run by Aqumen Biopharmaceuticals, N.A. at 22 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mature Cataracts
- What is being tested?
- DYME
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 22 sitesin 2 countries
- Study dates
- Apr 2007to May 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United States17 sites
Island Eye Surgicenter
Carle Place, New York, 11514
Wills Eye Surgery Center
Cherry Hill, New Jersey, 08002
The Ohio State University Hospital
Columbus, Ohio, 43210
McDonald Eye Associates
Fayetteville, Arkansas, 72703
Eye Surgeons of Indiana
Indianapolis, Indiana, 46256
Peace Laser Eye Center
Inglewood, California, 90301
Silverstein Eye Centers
Kansas City, Missouri, 64133
Eye Care Specialists
Kingston, Pennsylvania, 18704
The Eye Institute of West Florida
Largo, Florida, 33770
SMDV Surgery Center
Madison, Wisconsin, 53715
Center for Excellence in Eye Care
Miami, Florida, 33176
Wills Eye Surgery Center
Philadelphia, Pennsylvania, 19107
Wills Surgery Center
Philadelphia, Pennsylvania, 19145
Capitol City Surgery Center
Sacramento, California, 95815
St. John's Clinic Eye Specialists
Springfield, Missouri, 65804
Ballas Surgery Center
St Louis, Missouri, 63141
Brar-Parekh Eye Associates
Woodland Park, New Jersey, 07424
India5 sites
Narayana Nethralaya
Bangalore, Karnataka, 560020
Bhagwan Mahaveer Jain Hospital
Bangalore, Karnataka, 560052
Narayana Nethralaya
Bangalore, Karnataka, 560099
The Mehta International Eye Institute & Colaba Eye Hospital
Mumbai, Maharashtra, 400 005
Bombay City Eye Institute & Research Centre
Mumbai, Maharashtra, 400 007
About this study
Official 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
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
- Being tested
- DYME
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DYMEDrug
2ml of 0.25 mg/ml BBG 250 in sterile ophthalmic solution
DYMEDrug
2ml of 0.05 mg/ml BBG 250 in sterile ophthalmic solution
| Study group | Role | What they receive |
|---|---|---|
| High Dose | Active comparator | Not described Receives: Drug: DYME |
| Low Dose | Active comparator | Not described Receives: Drug: DYME |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal curvilinear capsulorrhexis with a single dose, as assessed by the surgeon based on the tissue dyed and subsequently removed.
Measured: During surgery
Uncomplicated discharge
Measured: one week post-op
Secondary outcomes (2)
Quality of stain
Measured: during surgery
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
Measured: 1-day and 1-week post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2008 (estimated)
- Study startApr 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mature CataractsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aqumen Biopharmaceuticals, N.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hardy Kagimoto, M.D., Study director, Aqumen Biopharmaceuticals, N.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00596583
- Sponsor's protocol ID
- AQNA-DY001
- Other IDs
- US IND 75,735
- Status last verified
- Feb 2009
- First submitted
- 9 Jan 2008
- Last updated
- 2 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00596583
- Acronym / sponsor ID
- AQNA-DY001
- Conditions
- Mature Cataracts
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Aqumen Biopharmaceuticals, N.A.Industry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 17 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Dose | Active comparator | Drug: DYME |
| Low Dose | Active comparator | Drug: DYME |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DYME2ml of 0.25 mg/ml BBG 250 in sterile ophthalmic solution | Drug | High Dose |
| DYME2ml of 0.05 mg/ml BBG 250 in sterile ophthalmic solution | Drug | Low Dose |
Primary outcome
Optimal curvilinear capsulorrhexis with a single dose, as assessed by the surgeon based on the tissue dyed and subsequently removed.
Time frame: During surgery
Uncomplicated discharge
Time frame: one week post-op
2 secondary outcomes
Quality of stain
Time frame: during surgery
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hardy Kagimoto, M.D. study director
Aqumen Biopharmaceuticals, N.A.
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DYME in people with Mature Cataracts, run by Aqumen Biopharmaceuticals, N.A. at 22 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal curvilinear capsulorrhexis with a single dose, as assessed by the surgeon based on the tissue dyed and subsequently removed. (time frame: During surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2009.