NCT06400589

Brief Summary

The objectives of this study are to compare the efficacy and safety of tanfanercept ophthalmic solution 0.25% and 1.0% to vehicle for the treatment of DED.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
750

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2024

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

May 31, 2024

Status Verified

May 1, 2024

Enrollment Period

1.3 years

First QC Date

April 29, 2024

Last Update Submit

May 29, 2024

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • Schirmer Test

    The proportion of participants with improvement from baseline in unanesthetized Schirmer

    12 weeks

Secondary Outcomes (5)

  • Schirmer Test

    2 weeks, 4 weeks, 8 weeks, 12 weeks

  • Symptom Assessment in Dry Eye

    2 weeks, 4 weeks, 8 weeks, 12 weeks

  • VAS

    2 weeks, 4 weeks, 8 weeks, 12 weeks

  • Conjunctival redness

    2 weeks, 4 weeks, 8 weeks, 12 weeks

  • Corneal staining

    2 weeks, 4 weeks, 8 weeks, 12 weeks

Other Outcomes (1)

  • Comfort Score (Exploratory)

    2 weeks, 4 weeks, 8 weeks

Study Arms (3)

0.25% tanfanercept

EXPERIMENTAL

0.25% tanfanercept ou bid for 12 weeks

Drug: tanfanercept

1.0% tanfanercept

EXPERIMENTAL

1.0% tanfanercept ou bid for 12 weeks

Drug: tanfanercept

Vehicle

PLACEBO COMPARATOR

Vehicle ou bid for 12 weeks

Drug: Vehicle

Interventions

tanfanerceptDRUG

TNF inhibitor

0.25% tanfanercept1.0% tanfanercept
VehicleDRUG

Same composition as tanfanercept but without the active ingredient

Vehicle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Are at least 18 years of age
  • Provide written informed consent
  • Are willing to attend all study visits and able to comply with study procedures and assessments
  • Have a self-reported history of DED (OU) for at least 6 months prior to Visit 1

You may not qualify if:

  • Have an uncontrolled systemic disease
  • Have been exposed to an investigational drug or device within 30 days or 5 half-lives prior to Visit 1, whichever is longer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HanAll Site #1

Delray Beach, Florida, 33484, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2024

First Posted

May 6, 2024

Study Start

May 1, 2024

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

May 31, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)