CataractPhase 2NCT00793091
Safety and Efficacy Study of an Ophthalmic Solution in Patients With Age-Related Cataract
A Phase 2 study testing C-KAD Ophthalmic Solution in people with Cataract, run by Chakshu Research, Inc. at 4 sites in United States.
Trial summary
The purpose of this study is to determine the safety and efficacy of C-KAD Ophthalmic Solution in improving visual acuity relative to placebo in patients with age-related cataract Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Cataract
- What is being tested?
- C-KAD Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2008to Sep 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of age-related cataract in the study eye
- Best-corrected visual acuity of 20/25 to 20/50 in the study eye
Who cannot join
- Any other clinical condition in the eye that may compromise vision
- Presence or History of Glaucoma
- Presence or history of diabetes
- Use of eyedrops
- Use of steroids
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
Charlotte Eye, Ear, Nose & Throat Associates
Charlotte, North Carolina, 28210
Merri Walker, 704-295-3386, mwalker@ceenta.com
Michael Rotberg, MD
- Recruiting
Minnesota Eye Consultants, PA
Minneapolis, Minnesota, 55405
Research Office, 612-813-3607, research@mneye.com
David Hardten, MD
- Recruiting
Hunkeler Eye Institute
Overland Park, Kansas, 66210
Margie Jones, 913-338-4733, mjones@hunkeler.com
John Hunkeler, MD
- Recruiting
Pacific Eye Specialists
San Francisco, California, 94115
Leslie Lyssenko, 650-726-1500, leslie@pacificeyespecialists.com
Lee Schwartz, MD
About this study
Official title: A Phase 2, Randomized, Placebo-Controlled, Double-Masked, Multicenter Safety and Efficacy Study of C-KAD Ophthalmic Solution in Patients With Loss of Visual Acuity Due to Age-Related Cataract
The purpose of this study is to determine the safety and efficacy of C-KAD Ophthalmic Solution in improving visual acuity relative to placebo in patients with age-related cataract
- Conditions
- Cataract
- Being tested
- C-KAD Ophthalmic Solution, Placebo
- Medical subject headings
- Cataract
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 120 days
PlaceboDrug
4 drops applied daily for 120 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: C-KAD Ophthalmic Solution |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-corrected visual acuity by ETDRS
Measured: 120 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionAug 2009 (estimated)
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 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
- NCT00793091
- Sponsor's protocol ID
- CK-0109
- Status last verified
- Nov 2008
- First submitted
- 17 Nov 2008
- Last updated
- 27 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Placebo-Controlled, Double-Masked, Multicenter Safety and Efficacy Study of C-KAD Ophthalmic Solution in Patients With Loss of Visual Acuity Due to Age-Related Cataract
- ClinicalTrials.gov ID
- NCT00793091
- Acronym / sponsor ID
- CK-0109
- Conditions
- Cataract
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chakshu Research, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Aug 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 19 Nov 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 purpose of this study is to determine the safety and efficacy of C-KAD Ophthalmic Solution in improving visual acuity relative to placebo in patients with age-related cataract
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: C-KAD Ophthalmic Solution |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Presence of age-related cataract in the study eye
- Best-corrected visual acuity of 20/25 to 20/50 in the study eye
Key exclusion criteria (5 listed)
- Any other clinical condition in the eye that may compromise vision
- Presence or History of Glaucoma
- Presence or history of diabetes
- Use of eyedrops
- Use of steroids
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 120 days | Drug | 1 |
| Placebo4 drops applied daily for 120 days | Drug | 2 |
Primary outcome
Best-corrected visual acuity by ETDRS
Time frame: 120 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2008.
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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.
Ira Wong, MD study director
Chakshu Research, Inc.
4 sites 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 Cataract, run by Chakshu Research, Inc. at 4 sites 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 2 inclusion and 5 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 27 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best-corrected visual acuity by ETDRS (time frame: 120 Days). 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 27 Nov 2008.