A Study to Assess the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution in Participants With Dry Eye

NCT05109702 | Completed Phase 3 Results FDA Drug

• 1 other identifier: HL036-DED-US-P302
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 10

Brief Summary

The objective of this study was to compare the safety and efficacy of tanfanercept ophthalmic solution 0.25% with placebo for the treatment of the signs and symptoms of dry eye.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Central Corneal Staining Score (CCSS) at Day 57

  CCSS was graded using the Ora Calibra® Corneal and Conjunctival Fluorescein Staining Scale. The Ora Calibra® Corneal and Conjunctival Staining Scale ranged 0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, and 4 = Severe; lower score indicated improvement.

  Baseline, Day 57 (Week 8)

• Change From Baseline in Eye Dryness Score (EDS) Assessed by Visual Analogue Scale at Day 57

  Eye dryness score was scored on a Visual Analogue Scale (VAS) that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).

  Baseline, Day 57 (Week 8)

Secondary Outcomes (33)

• Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Central Region

  Baseline; Weeks 1, 2, 4, and 8

• Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Superior Region

  Baseline; Weeks 1, 2, 4, and 8

• Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Inferior Region

  Baseline; Weeks 1, 2, 4, and 8

• Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Temporal Region

  Baseline; Weeks 1, 2, 4, and 8

• Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Nasal Region

  Baseline; Weeks 1, 2, 4, and 8

Study Arms (3)

Placebo Run-in

OTHER

Participants self-administered placebo ocular drops, twice daily (BID) in both eyes for 14 days in the Placebo Run-in Period.

Drug: Placebo

0.25% Tanfanercept Ophthalmic Solution

EXPERIMENTAL

Participants self-administered tanfanercept 0.25 percent (%) ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.

Drug: 0.25% Tanfanercept Ophthalmic Solution

Placebo

PLACEBO COMPARATOR

Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.

Drug: Placebo

Interventions

0.25% Tanfanercept Ophthalmic Solution DRUG

Tanfanercept ophthalmic solution.

Also known as: HL036

0.25% Tanfanercept Ophthalmic Solution

Placebo DRUG

Placebo vehicle solution.

Placebo; Placebo Run-in

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a participant-reported history of dry eye for at least 6 months prior to Visit 1
• Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1
• Have a best-corrected visual acuity (BCVA) of 0.7 minimum angle of resolution (logMAR) or better (Snellen equivalent score of 20/100 or better) in each eye at Visit 1
• Report a score of ≥ 2 according to the Ora Calibra® ocular discomfort \& 4-symptom questionnaire in at least one of the dry eye symptoms at Visits 1 and 2
• Have a Schirmer's Test score of ≤ 10 millimeter (mm) and ≥ 1 mm in at least one eye at Visits 1 and 2
• Have a corneal fluorescein staining score ≥ 2 according to the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining in at least 1 of the corneal regions (inferior, superior, or central) in at least 1 eye at Visits 1 and 2
• Have a conjunctival redness score ≥ 1 according to the Ora Calibra® conjunctival redness for dry eye scale in at least 1 eye at Visits 1 and 2

You may not qualify if:

• Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction, lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters
• Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1
• Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study
• Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months
• Have used any cyclosporine-containing drops (such as Restasis®, Cequa®), or lifitegrast ophthalmic solution (Xiidra®) within 60 days of Visit 1
• Have any previous experience using TNF inhibitor ophthalmic solutions, such Tanfanercept Ophthalmic Solution
• Be currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial (excluding medications allowed for the conduct of the study)
• Be a woman who is pregnant, nursing or planning a pregnancy

Sponsors & Collaborators

• HanAll BioPharma Co., Ltd.: lead
• Daewoong Pharmaceutical Co. LTD.: collaborator

Study Sites (10)

Cornea & Cataract Consultants of Arizona

Phoenix, Arizona, 85032, United States

Location

Global Research Management

Glendale, California, 91204, United States

Location

Eye Research Foundation, Inc.

Newport Beach, California, 92663, United States

Location

The Eye Care Institute - Butchertown Clinical Trials

Louisville, Kentucky, 40206, United States

Location

Andover Eye Associates: Raynham

Raynham, Massachusetts, 02767, United States

Location

Center For Sight

Henderson, Nevada, 89052, United States

Location

Oculus Research, Inc.

Garner, North Carolina, 27529, United States

Location

Scott & Christie and Associates, PC

Cranberry Township, Pennsylvania, 16066, United States

Location

Andover Eye Associates: Warwick

Warwick, Rhode Island, 02886, United States

Location

Advancing Vision Research, LLC.

Smyrna, Tennessee, 37072, United States

Location

Related Publications (1)

• Mangwani-Mordani S, Goodman CF, Galor A. Novel Treatments for Chronic Ocular Surface Pain. Cornea. 2023 Mar 1;42(3):261-271. doi: 10.1097/ICO.0000000000003193. Epub 2022 Dec 19.

  PMID: 36729473 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Project Manager
• Organization: Hanall Biopharma

parksm@hanall.co.kr

82-222041763

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 5, 2021
• Study Start: November 18, 2021
• Primary Completion: May 6, 2022
• Study Completion: May 6, 2022
• Last Updated: October 23, 2023
• Results First Posted: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)