Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2026-01-13 @ 12:41 AM
Study NCT ID:
NCT01476332
Status:
COMPLETED
Last Update Posted:
2012-05-17
First Post:
2011-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and Pharmacokinetics of 0.5% and 2.5% Cis-UCA Eye Drops in Adult Healthy Volunteers (Phase I)
Sponsor:
Laurantis Pharma, Ltd.
Organization:
Study Overview
Official Title:
A Single Dose (Part 1) and Multiple Dose (Part 2) Phase I, Double-blind, Placebo-controlled, Safety, Tolerability and Pharmacokinetic Study of 0.5% and 2.5% Cis-UCA Eye Drops in Adult Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this two-part study is to evaluate safety, tolerability and pharmacokinetics of 0.5% and 2.5% cis-UCA eye drops in comparison to placebo in adult healthy volunteers.
Detailed Description:
This is a Phase I single-centre, double-blind, placebo-controlled, single and multiple dose study to evaluate safety, ocular tolerability and pharmacokinetics of 0.5% and 2.5% cis-UCA eye drops in healthy volunteers for up to 15 days. After the single day dose (three times) on day 1 and the subsequent 7 (± 1) days wash-out period, a multidose phase with three times a day administration for 14 days will start
Primary objectives:
* Part 1: To evaluate the safety and ocular tolerability of 0.5% and 2.5% cis-UCA eye drops and placebo for cis-UCA eye drops when administered on a randomized eye three times during a single day, assessed up to 7 (± 1) days following dosing in healthy volunteers
* Part 2: To evaluate the safety and ocular tolerability of 0.5% and 2.5% cis-UCA eye drops and placebo for cis-UCA eye drops when administered on both eyes three times a day for 14 days, assessed up to 7 days following the last dosing in healthy volunteers
Secondary objectives:
* To evaluate single dose pharmacokinetics of 0.5% and 2.5% cis-UCA eye drops when administered on a randomized eye in adult healthy volunteers
* To evaluate the pharmacokinetics of 0.5% and 2.5% cis-UCA eye drops when administered on both eyes three times a day for 14 days in adult healthy volunteers
Healthy male or female volunteer, 18-65 years of age, with no history of significant eye disease or any current eye disease that would affect the pharmacokinetics of cis-UCA. Subjects without any treatment-emergent adverse events during Part 1 may continue to Part 2 of the study.
Primary objectives:
* Part 1: To evaluate the safety and ocular tolerability of 0.5% and 2.5% cis-UCA eye drops and placebo for cis-UCA eye drops when administered on a randomized eye three times during a single day, assessed up to 7 (± 1) days following dosing in healthy volunteers
* Part 2: To evaluate the safety and ocular tolerability of 0.5% and 2.5% cis-UCA eye drops and placebo for cis-UCA eye drops when administered on both eyes three times a day for 14 days, assessed up to 7 days following the last dosing in healthy volunteers
Secondary objectives:
* To evaluate single dose pharmacokinetics of 0.5% and 2.5% cis-UCA eye drops when administered on a randomized eye in adult healthy volunteers
* To evaluate the pharmacokinetics of 0.5% and 2.5% cis-UCA eye drops when administered on both eyes three times a day for 14 days in adult healthy volunteers
Healthy male or female volunteer, 18-65 years of age, with no history of significant eye disease or any current eye disease that would affect the pharmacokinetics of cis-UCA. Subjects without any treatment-emergent adverse events during Part 1 may continue to Part 2 of the study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2011-004283-30 | EUDRACT_NUMBER | None | View |