Asteroid HyalosisPhase 2NCT00825942
An Open-Label Study of the Effect of an Ophthalmic Solution on Asteroid Hyalosis
A Phase 2 study testing C-KAD Ophthalmic Solution in people with Asteroid Hyalosis, run by Chakshu Research, Inc. at 1 site in United States.
Trial summary
To determine the safety and initial efficacy of C-KAD ophthalmic solution in patients with asteroid hyalosis Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Asteroid Hyalosis
- What is being tested?
- C-KAD Ophthalmic Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Nov 2009
- Phase
- Phase 2
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of asteroid hyalosis
Who cannot join
- Active ocular infection
- Glaucoma
- Ocular hypertension
- Ocular inflammatory disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Mountain View Optometry and Contact Lens Clinic
Mountain View, California, 94041
About this study
Official title: An Open-Label Study of the Effect of C-KAD Ophthalmic Solution on Asteroid Hyalosis
To determine the safety and initial efficacy of C-KAD ophthalmic solution in patients with asteroid hyalosis
- Conditions
- Asteroid Hyalosis
- Being tested
- C-KAD Ophthalmic Solution
- Keywords
- Asteroid hyalosis, Opthalmic Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-KAD Ophthalmic SolutionDrug
4 drops applied daily for 180 days
| Study group | Role | What they receive |
|---|---|---|
| C-KAD Ophthalmic Solution | Experimental | Not described Receives: Drug: C-KAD Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the number of asteroid bodies
Measured: 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startJul 2008
- Primary completionOct 2009 (estimated)
- Study completionNov 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asteroid HyalosisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chakshu Research, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ira Wong, MD, Study director, Chakshu Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825942
- Sponsor's protocol ID
- PCK-0108
- Status last verified
- Apr 2009
- First submitted
- 19 Jan 2009
- Last updated
- 17 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of the Effect of C-KAD Ophthalmic Solution on Asteroid Hyalosis
- ClinicalTrials.gov ID
- NCT00825942
- Acronym / sponsor ID
- PCK-0108
- Conditions
- Asteroid Hyalosis
- Keywords
- Asteroid hyalosis, Opthalmic Study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chakshu Research, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Nov 2009 (estimated)
- First posted
- 21 Jan 2009 (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.
To determine the safety and initial efficacy of C-KAD ophthalmic solution in patients with asteroid hyalosis
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| C-KAD Ophthalmic Solution | Experimental | Drug: C-KAD Ophthalmic Solution |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Presence of asteroid hyalosis
Key exclusion criteria (4 listed)
- Active ocular infection
- Glaucoma
- Ocular hypertension
- Ocular inflammatory disorders
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 |
|---|---|---|
| C-KAD Ophthalmic Solution4 drops applied daily for 180 days | Drug | C-KAD Ophthalmic Solution |
Primary outcome
Reduction in the number of asteroid bodies
Time frame: 180
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2009.
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.
Ira Wong, MD study director
Chakshu Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing C-KAD Ophthalmic Solution in people with Asteroid Hyalosis, run by Chakshu Research, Inc. at 1 site in United States.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Reduction in the number of asteroid bodies (time frame: 180). 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 17 Apr 2009.