Ocular HypertensionNCT00825396
An Open-Label Study of an Ophthalmic Solution to Reduce Intraocular Pressure in Patients With Ocular Hypertension
A study testing C-KAD Ophthalmic Solution in people with Ocular Hypertension, run by Chakshu Research, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and tolerability of topical C-KAD Ophthalmic Solution in reducing intraocular pressure in patients with ocular hypertension. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Ocular Hypertension
- What is being tested?
- C-KAD Ophthalmic Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Apr 2009
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both eyes having intraocular pressure in the range of 22-30 mmHg at baseline
- Both eyes having best corrected visual acuity better than 20/50
Who cannot join
- Advanced glaucoma
- Closed or barely open anterior chamber or history of angle closure
Trial locations and contacts
1 site in 1 country.
United States1 site
Charlotte Eye, Ear, Nose & Throat Associates
Charlotte, North Carolina, 28210
About this study
Official title: A Pilot, Open-Label, Controlled Clinical Trial of C-KAD Ophthalmic Solution in Reducing Intraocular Pressure in Patients With Ocular Hypertension
The purpose of this study is to determine the safety and tolerability of topical C-KAD Ophthalmic Solution in reducing intraocular pressure in patients with ocular hypertension.
- Conditions
- Ocular Hypertension
- Being tested
- C-KAD Ophthalmic Solution
- Medical subject headings
- Ocular Hypertension
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 150 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.
Mean change in intraocular pressure from baseline
Measured: 150 Days
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 startApr 2007
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular HypertensionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT00825396
- Sponsor's protocol ID
- PCK-0106
- Status last verified
- Jun 2009
- First submitted
- 16 Jan 2009
- Last updated
- 11 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Open-Label, Controlled Clinical Trial of C-KAD Ophthalmic Solution in Reducing Intraocular Pressure in Patients With Ocular Hypertension
- ClinicalTrials.gov ID
- NCT00825396
- Acronym / sponsor ID
- PCK-0106
- Conditions
- Ocular Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Chakshu Research, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- 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.
The purpose of this study is to determine the safety and tolerability of topical C-KAD Ophthalmic Solution in reducing intraocular pressure in patients with ocular hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- 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
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Both eyes having intraocular pressure in the range of 22-30 mmHg at baseline
- Both eyes having best corrected visual acuity better than 20/50
Key exclusion criteria (2 listed)
- Advanced glaucoma
- Closed or barely open anterior chamber or history of angle closure
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 150 days | Drug | C-KAD Ophthalmic Solution |
Primary outcome
Mean change in intraocular pressure from baseline
Time frame: 150 Days
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 11 Jun 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.
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 study testing C-KAD Ophthalmic Solution in people with Ocular Hypertension, 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 2 inclusion and 2 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 11 Jun 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.
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?
Mean change in intraocular pressure from baseline (time frame: 150 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 11 Jun 2009.