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A Study to Evaluate the Efficacy and Safety of Tanfanercept (HL036) in Dry Eye Disease (VELOS-4)

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HanAll Biopharma

Status and phase

Suspended
Phase 3

Conditions

Dry Eye

Treatments

Drug: tanfanercept
Drug: Vehicle

Study type

Interventional

Funder types

Industry

Identifiers

NCT06400589
HL036-DED-US-P303

Details and patient eligibility

About

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.

Full description

The purpose of this research study is to test the safety and effectiveness (how well the drug works) of Tanfanercept ophthalmic solution 0.25% and Tanfanercept ophthalmic solution 1% against vehicle (no active treatment). Effectiveness will be measured by the improvement in Schirmer Test results (a test to see how many tears you produce), reduction of dry eye symptoms, eye redness (conjunctival redness), and eye surface irritation (corneal staining, conjunctival staining). Eye safety assessments will also be performed.

Enrollment

750 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

750 participants in 3 patient groups, including a placebo group

0.25% tanfanercept
Experimental group
Description:
0.25% tanfanercept ou bid for 12 weeks
Treatment:
Drug: tanfanercept
1.0% tanfanercept
Experimental group
Description:
1.0% tanfanercept ou bid for 12 weeks
Treatment:
Drug: tanfanercept
Vehicle
Placebo Comparator group
Description:
Vehicle ou bid for 12 weeks
Treatment:
Drug: Vehicle

Trial contacts and locations

1

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Central trial contact

Sr. Director Clinical Development

Data sourced from clinicaltrials.gov

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