Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-01-11 @ 12:27 PM
Study NCT ID:
NCT03088605
Status:
COMPLETED
Last Update Posted:
2024-02-14
First Post:
2017-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of TOP1630 for Dry Eye Syndrome
Sponsor:
ORA, Inc.
Organization:
Study Overview
Official Title:
A Single-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of TOP1630 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Syndrome
Status:
COMPLETED
Status Verified Date:
2024-01
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:
In subjects with Dry Eye Syndrome:
The primary objective of this study is to compare the safety and tolerability of TOP1630 Ophthalmic Solution to placebo.
The secondary objectives are to compare the efficacy of TOP1630 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye syndrome.
The primary objective of this study is to compare the safety and tolerability of TOP1630 Ophthalmic Solution to placebo.
The secondary objectives are to compare the efficacy of TOP1630 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye syndrome.
Detailed Description:
This study is designed to assess the safety, tolerability and efficacy of TOP1630 ophthalmic solution in subjects with Dry Eye Syndrome.
Eligible subjects will be randomized double masked to either TOP1630 or placebo.
Part 1 (time frame 12 days) comprises assessment of safety, tolerability and ocular comfort.
Part 2 (time frame 35 days) comprises assessment of safety, tolerability and efficacy
Eligible subjects will be randomized double masked to either TOP1630 or placebo.
Part 1 (time frame 12 days) comprises assessment of safety, tolerability and ocular comfort.
Part 2 (time frame 35 days) comprises assessment of safety, tolerability and efficacy
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: