NCT06639711

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

1.4 years

First QC Date

October 10, 2024

Last Update Submit

December 4, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visual Acuity

    1 Year

Study Arms (1)

Application of Taurine-containing Eye Drops

EXPERIMENTAL
Drug: Taurine

Interventions

Taurine-containing eye drops (VIZILOTON) are applied 4 times daily for a period of one year

Also known as: VIZILOTIN Eye Drops
Application of Taurine-containing Eye Drops

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Nahrain Eye Clinics

Ramadi, Al-Anbar Governorate, 31001, Iraq

Location

MeSH Terms

Conditions

Cataract

Interventions

Taurine

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Alkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: single-arm pre-post intervention study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Dr. Atheer Zgair

Study Record Dates

First Submitted

October 10, 2024

First Posted

October 15, 2024

Study Start

July 10, 2023

Primary Completion

December 20, 2024

Study Completion

December 20, 2024

Last Updated

December 9, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations