CataractPhase 1/2NCT06639711
Taurine Eye Drops May Prevent the Progression of Cataract
A Phase 1/2 study testing Taurine in people with Cataract, run by University Of Anbar at 1 site in Iraq.
Trial summary
The aim of the current intervention study is to determine the effectiveness of taurine containing eye drops (available under brand name VIZILOTON) to prevent the progression of grade I and II senile cataract. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Taurine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIraq
- Study dates
- 10 Jul 2023to 20 Dec 2024
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- The presence of grade I or II senile cataract on one or two eyes.
Who cannot join
- clinical signs of glaucoma
- history of amblyopia, eye surgery, argon or YAG laser eye treatment, or major eye trauma
- history of iritis, retinal crystalline deposits, or optic nerve disease
- visually significant fundus pathology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Taurine Affects the Progression of Senile Cataract: a Single-arm Pre-post Intervention Study
The aim of the current intervention study is to determine the effectiveness of taurine containing eye drops (available under brand name VIZILOTON) to prevent the progression of grade I and II senile cataract.
This study could answer:
Read more
- Dose continuous use of taurine-containing eye drops could prevent further deterioration of vision in mild cases of cataract?
- The acceptance/ compliance of participants to taurine-containing eye drops.
- Could long-term use of taurine-containing eye drops cause adverse effect(s)?
Participants will:
- Take taurine-containing eye drops (VIZILOTON eye drops) 4 times a day for one year.
- Visit eye clinic every 3 months for assessment and visual examination.
- Keep notes for their symptoms and their adherence to treatment.
- Conditions
- Cataract
- Being tested
- Taurine
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaurineDrug
Also called VIZILOTIN Eye Drops
Taurine-containing eye drops (VIZILOTON) are applied 4 times daily for a period of one year
| Study group | Role | What they receive |
|---|---|---|
| Application of Taurine-containing Eye Drops | Experimental | Not described Receives: Drug: Taurine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start10 Jul 2023
- Primary completion20 Dec 2024 (estimated)
- Study completion20 Dec 2024 (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 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single-arm pre-post intervention study
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Of Anbar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atheer Zgair, University Of Anbar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639711
- Sponsor's protocol ID
- UOANBAR-170
- Status last verified
- Dec 2024
- First submitted
- 10 Oct 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taurine Affects the Progression of Senile Cataract: a Single-arm Pre-post Intervention Study
- ClinicalTrials.gov ID
- NCT06639711
- Acronym / sponsor ID
- UOANBAR-170
- Conditions
- Cataract
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Of AnbarUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 15 Oct 2024 (actual)
- 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 aim of the current intervention study is to determine the effectiveness of taurine containing eye drops (available under brand name VIZILOTON) to prevent the progression of grade I and II senile cataract.
This study could answer:
- Dose continuous use of taurine-containing eye drops could prevent further deterioration of vision in mild cases of cataract?
- The acceptance/ compliance of participants to taurine-containing eye drops.
- Could long-term use of taurine-containing eye drops cause adverse effect(s)?
Participants will:
- Take taurine-containing eye drops (VIZILOTON eye drops) 4 times a day for one year.
- Visit eye clinic every 3 months for assessment and visual examination.
- Keep notes for their symptoms and their adherence to treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-arm pre-post intervention study
| Arm | Type | Receives |
|---|---|---|
| Application of Taurine-containing Eye Drops | Experimental | Drug: Taurine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The presence of grade I or II senile cataract on one or two eyes.
Key exclusion criteria (4 listed)
- clinical signs of glaucoma
- history of amblyopia, eye surgery, argon or YAG laser eye treatment, or major eye trauma
- history of iritis, retinal crystalline deposits, or optic nerve disease
- visually significant fundus pathology
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 |
|---|---|---|
| TaurineAlso: VIZILOTIN Eye DropsTaurine-containing eye drops (VIZILOTON) are applied 4 times daily for a period of one year | Drug | Application of Taurine-containing Eye Drops |
Primary outcome
Visual Acuity
Time frame: 1 Year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Taurine in people with Cataract, run by University Of Anbar at 1 site in Iraq.
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: under way, not looking for participants, as of the sponsor's last update on 9 Dec 2024. 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 Iraq. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
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?
Visual Acuity (time frame: 1 Year). 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 9 Dec 2024.