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0.25% Tanfanercept Ophthalmic Solution for Dry Eye Syndrome (VELOS-3 Trial)

Phase 3
Waitlist Available
Research Sponsored by HanAll BioPharma Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; weeks 1, 2, 4, and 8
Awards & highlights

VELOS-3 Trial Summary

This trial compares the safety and effectiveness of a new eye drop medication for treating dry eye symptoms against a placebo.

Eligible Conditions
  • Dry Eye Syndrome

VELOS-3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; weeks 1, 2, 4, and 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; weeks 1, 2, 4, and 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Central Corneal Staining Score (CCSS) at Day 57
Change From Baseline in Eye Dryness Score (EDS) Assessed by Visual Analogue Scale at Day 57
Secondary outcome measures
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Central Region
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Conjunctival Sum
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Corneal Sum
+30 more

VELOS-3 Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Placebo Run-inExperimental Treatment1 Intervention
Participants self-administered placebo ocular drops, twice daily (BID) in both eyes for 14 days in the Placebo Run-in Period.
Group II: 0.25% Tanfanercept Ophthalmic SolutionExperimental Treatment1 Intervention
Participants self-administered tanfanercept 0.25 percent (%) ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Group III: PlaceboPlacebo Group1 Intervention
Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
0.25% Tanfanercept Ophthalmic Solution
2021
Completed Phase 3
~260
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

HanAll BioPharma Co., Ltd.Lead Sponsor
15 Previous Clinical Trials
1,719 Total Patients Enrolled
Daewoong Pharmaceutical Co. LTD.Industry Sponsor
190 Previous Clinical Trials
155,750 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial accessible in many places around town?

"Currently, patients are being enrolled at Oculus Research, Inc. in Garner, North carolina, Andover Eye Associates: Warwick in Warwick, Rhode island, and Advancing Vision Research, LLC. in Phoenix, Arizona with 11 other medical facilities participating."

Answered by AI

Can people sign up for the trial at this time?

"The listed criteria on clinicaltrials.gov suggests that this study is still looking for participants. This particular trial was first advertised on November 18th, 2021 and the most recent update was August 31st, 2022."

Answered by AI

How many patients will be enrolled in this experiment at most?

"The information on clinicaltrials.gov does show that this trial is currently looking for participants. The earliest posting was on 11/18/2021, with the most recent update being 8/31/2022. They are 300 patients needed between 11 different sites."

Answered by AI

Is there a high chance of developing complications from using 0.25% HL036 Ophthalmic Solution?

"There is some clinical data to support the efficacy of 0.25% HL036 Ophthalmic Solution, and as it is a Phase 3 trial, there are multiple rounds of data supporting its safety--so our team has rated it a 3."

Answered by AI

What therapeutic benefits does this trial hope to find?

"The aim of this clinical trial, which will take place over a Baseline and Day 57 time frame, is to observe the Change from Baseline in Central Corneal Staining Score (CCSS) at Day 57. Additionally, secondary outcomes such as the Change from Baseline in Fluorescein Staining by Region (Central, Superior, Inferior, Temporal, Nasal, Corneal sum, Conjunctival Sum and Total staining) at Weeks 1, 2, 4, and 8 will be monitored. This is defined as The score for individual region is assessed by the Ora Calibra®"

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
How old are they?
65+
What site did they apply to?
Scott & Christie and Associates, PC
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution in Participants With Dry Eye
2021. "A Study to Assess the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution in Participants With Dry Eye". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05109702.
~76 spots leftby Apr 2025
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