Nuclear CataractPhase 2NCT00825721
Dose-Ranging Study of an Ophthalamic Solution in Patients With Loss of Visual Function Due to Age-Related Nuclear Cataract
A Phase 2 study testing LiquiTears and C-KAD Ophthalmic Solution in people with Nuclear Cataract, run by Chakshu Research, Inc. at 1 site in Nepal.
Trial summary
This study will evaluate the safety and efficacy of three doses of C-KAD Ophthalmic Solution in patients with loss of visual function due to age-related nuclear cataract Read more about this study
- Who is it for?
- Ages 35 to 90 years
- Conditions the study is for
- Nuclear Cataract
- What is being tested?
- LiquiTears and C-KAD Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteNepal
- Study dates
- Nov 2007to 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 35 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of nuclear sclerosis cataract
- BCDVA within the range of 20/40 and 20/80
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
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-Controlled, Single-Masked, Dose-Ranging Study of C-KAD Ophthalmic Solution in Patients With Loss of Visual Function Due to Age-Related Nuclear Cataracts
This study will evaluate the safety and efficacy of three doses of C-KAD Ophthalmic Solution in patients with loss of visual function due to age-related nuclear cataract
- Conditions
- Nuclear Cataract
- Being tested
- LiquiTears, C-KAD Ophthalmic Solution
- Keywords
- Cataract Study, Ophthalmic Study, Agerelated cataract, Nuclear Cataract, Low grade nuclear cataracts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiquiTearsDrug
4 drops applied daily for 360 days
C-KAD Ophthalmic SolutionDrug
4 drops applied daily for 360 days
C-KAD Ophthalmic SolutionDrug
4 drops applied daily for 360 days
C-KAD Ophthalmic SolutionDrug
4 drops applied daily for 360 days
| Study group | Role | What they receive |
|---|---|---|
| 1.3% (low dose) | Active comparator | Not described Receives: Drug: C-KAD Ophthalmic Solution |
| 2% (medium dose) | Active comparator | Not described Receives: Drug: C-KAD Ophthalmic Solution |
| 2.6% (high dose) | Active comparator | Not described Receives: Drug: C-KAD Ophthalmic Solution |
| Placebo | Placebo comparator | Not described Receives: Drug: LiquiTears |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-corrected visual acuity by ETDRS
Measured: 360 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 startNov 2007
- 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 Nuclear 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
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chakshu Research, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sanduk Ruit, MD, Principal investigator, Tilganga Eye CenterReeta Gurung, MD, Principal investigator, Tilganga Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825721
- Sponsor's protocol ID
- CK-0105
- Status last verified
- Jan 2009
- First submitted
- 19 Jan 2009
- Last updated
- 21 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Single-Masked, Dose-Ranging Study of C-KAD Ophthalmic Solution in Patients With Loss of Visual Function Due to Age-Related Nuclear Cataracts
- ClinicalTrials.gov ID
- NCT00825721
- Acronym / sponsor ID
- CK-0105
- Conditions
- Nuclear Cataract
- Keywords
- Cataract Study, Ophthalmic Study, Agerelated cataract, Nuclear Cataract, Low grade nuclear cataracts
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Chakshu Research, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Aug 2009 (estimated)
- Study completion
- Sep 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.
This study will evaluate the safety and efficacy of three doses of C-KAD Ophthalmic Solution in patients with loss of visual function due to age-related nuclear cataract
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1.3% (low dose) | Active comparator | Drug: C-KAD Ophthalmic Solution |
| 2% (medium dose) | Active comparator | Drug: C-KAD Ophthalmic Solution |
| 2.6% (high dose) | Active comparator | Drug: C-KAD Ophthalmic Solution |
| Placebo | Placebo comparator | Drug: LiquiTears |
Who may qualify
- Ages
- 35 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Presence of nuclear sclerosis cataract
- BCDVA within the range of 20/40 and 20/80
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 |
|---|---|---|
| LiquiTears4 drops applied daily for 360 days | Drug | Placebo |
| C-KAD Ophthalmic Solution4 drops applied daily for 360 days | Drug | 1.3% (low dose) |
| C-KAD Ophthalmic Solution4 drops applied daily for 360 days | Drug | 2% (medium dose) |
| C-KAD Ophthalmic Solution4 drops applied daily for 360 days | Drug | 2.6% (high dose) |
Primary outcome
Best-corrected visual acuity by ETDRS
Time frame: 360 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 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.
Sanduk Ruit, MD principal investigator
Tilganga Eye Center
Reeta Gurung, MD principal investigator
Tilganga Eye Center
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 LiquiTears and C-KAD Ophthalmic Solution in people with Nuclear Cataract, run by Chakshu Research, Inc. at 1 site in Nepal.
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 21 Jan 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 Nepal. 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?
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?
Best-corrected visual acuity by ETDRS (time frame: 360 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 21 Jan 2009.