Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2026-03-09 @ 4:05 AM
Study NCT ID:
NCT02078661
Status:
COMPLETED
Last Update Posted:
2014-03-05
First Post:
2013-12-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of PG101 for Dry Eye Syndrome
Sponsor:
Rhodes Pharmaceuticals, L.P.
Organization:
Study Overview
Official Title:
A Single Center, Randomized, Double-Masked, Placebo Controlled Study Evaluating the Safety and Efficacy of 0.25% PG101 and 1.0% PG101 in Subjects With Dry Eye Syndrome
Status:
COMPLETED
Status Verified Date:
2014-03
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:
PG101
Brief Summary:
To evaluate the safety and efficacy of 0.25% PG101 and 1.0% PG101 topical gel suspension compared to placebo when administered two times daily for 14 days in subjects diagnosed with dry eye syndrome
Detailed Description:
The topical product PG101 is expected to be efficacious in treating the symptoms of dry eye such as discomfort, dryness, grittiness, burning, stinging, photophobia, lid friction, mucus discharge and hyper-tearing. Two concentrations (0.25% and 1.0%) are included in the study to determine if there is a dose response effect.
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 |
|---|---|---|---|---|
| 13-110-0002 | OTHER | Rhodes Pharmaceuticals L.P. | View |