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

NCT ID: NCT05109702

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-18
• Study Completion Date: 2022-05-06

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo Run-in

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

Group Type: OTHER

Placebo

Intervention Type: DRUG

Placebo vehicle solution.

0.25% Tanfanercept Ophthalmic Solution

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

Group Type: EXPERIMENTAL

0.25% Tanfanercept Ophthalmic Solution

Intervention Type: DRUG

Tanfanercept ophthalmic solution.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo vehicle solution.

Interventions

0.25% Tanfanercept Ophthalmic Solution

Tanfanercept ophthalmic solution.

Intervention Type: DRUG

Placebo

Placebo vehicle solution.

Intervention Type: DRUG

Other Intervention Names

HL036

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role: collaborator

HanAll BioPharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cornea & Cataract Consultants of Arizona

Phoenix, Arizona, United States

Global Research Management

Glendale, California, United States

Eye Research Foundation, Inc.

Newport Beach, California, United States

The Eye Care Institute - Butchertown Clinical Trials

Louisville, Kentucky, United States

Andover Eye Associates: Raynham

Raynham, Massachusetts, United States

Center For Sight

Henderson, Nevada, United States

Oculus Research, Inc.

Garner, North Carolina, United States

Scott & Christie and Associates, PC

Cranberry Township, Pennsylvania, United States

Andover Eye Associates: Warwick

Warwick, Rhode Island, United States

Advancing Vision Research, LLC.

Smyrna, Tennessee, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36729473 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

HL036-DED-US-P302

Identifier Type: -

Identifier Source: org_study_id