Taurine Eye Drops May Prevent the Progression of Cataract | NCT06639711

Studies
Taurine Eye Drops May Prevent the Progression of Cataract

NCT06639711

Sponsor

University Of Anbar

Status

Active, not recruiting

Last Update Posted

Dec 9, 2024Actual

Enrollment

50Actual

Phase

Phase 1Phase 2

Conditions

Cataract

Interventions

Taurine

Countries

Iraq

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 10, 2023Actual

Primary Completion Date

Dec 20, 2024Estimated

Completion Date

Dec 20, 2024Estimated

First Submitted Date

Oct 10, 2024

First Submission Date that Met QC Criteria

Oct 10, 2024

First Posted Date

Oct 15, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2024

Last Update Posted Date

Dec 9, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Application of Taurine-containing Eye Drops	Experimental		Drug: Taurine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Taurine	Drug	Taurine-containing eye drops (VIZILOTON) are applied 4 times daily for a period of one year	Application of Taurine-containing Eye Drops

Measure	Description	Time Frame
Visual Acuity		1 Year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The presence of grade I or II senile cataract on one or two eyes.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Al-Nahrain Eye Clinics		Ramadi	Al-Anbar Governorate	31001	Iraq

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D002386	Cataract

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D013654	Taurine

Ancestor Terms

ID	Term
D017738	Alkanesulfonic Acids
D000473	Alkanes
D006839	Hydrocarbons, Acyclic
D006838	Hydrocarbons

Browse Leaves

Not provided

Browse Branches

Not provided