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â??Comparison of single and multidose pharmacokinetics of Posaconazole eye dropsâ??

â??Comparative evaluation of single and multidose ocular kinetics of topical posaconazole in humansâ??

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/07/055226
Enrollment
60
Registered
2023-07-14
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H251- Age-related nuclear cataract

Interventions

Intervention1: Topical posaconazole eyedrop 1 % instillation for pharmacokinetics analysis : Patients and healthy volunteers will receive single dose and multidose (1 hourly & 2 hourly, total 5 doses)

Sponsors

Prof M Vanathi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients and healthy volunteers consent to participate in this study

Exclusion criteria

Exclusion criteria: patients less than 18 years of age not willing to participate in this study patients with complicated cataract

Design outcomes

Secondary

MeasureTime frame
To compare the ocular penetration and aqueous concentration of single dose and multi dose application of 1% concentration of topical Posaconazole eye drop.Timepoint: after 1 hour of last drop instillation

Primary

MeasureTime frame
The primary objective of this study will be to evaluate the pharmacokinetics of single and multiple doses of topical Posaconazole eye drop in human eye.Timepoint: aqueous and tear fluid analysis after 1 hour of last drop of posaconazole instillation

Countries

India

Contacts

Public ContactM Vanathi

All India Institute of Medical Sciences, New delhi

mvanathirpc@gmail.com9400977217

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026