A Study to Assess Efficacy and Safety of HL036 in Subjects With Dry Eyes

NCT03846453 | Completed Phase 3 Results FDA Drug

• 1 other identifier: HL036-DED-US-P301
• Study Type: interventional
• Target: 637
• Locations: 1 country
• Sites: 12

Brief Summary

The objective of this study was to compare the safety and efficacy of 0.25% HL036 Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (2)

• Coprimary Endpoint: Change From Baseline in Inferior Corneal Fluorescein Staining Score to Day 57 (Pre- to Post-CAE)

  It was evaluated for the inferior region on the Ora Calibra® and Conjunctival staining scale. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.

  Pre-CAE and Post-CAE on Day 1 (Baseline) and Day 57

• Coprimary Endpoint: Change From Baseline in Ocular Discomfort Score to Day 57 (Pre-CAE)

  It is assessed by the Ora Calibra® Ocular Discomfort scale. The score ranged from 0 to 4 (0=none and 4=severe) with 1 point increments, where lower scores indicate improvement.

  Baseline (Day 1 Pre-CAE), Day 57 (Pre-CAE)

Secondary Outcomes (39)

• Mean Change From Baseline in Fluorescein Staining (Inferior Region)

  Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)

• Mean Change From Baseline in Fluorescein Staining (Superior Region)

  Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)

• Mean Change From Baseline in Fluorescein Staining (Central Region)

  Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)

• Mean Change From Baseline in Fluorescein Staining (Temporal Region)

  Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)

• Mean Change From Baseline in Fluorescein Staining (Nasal Region)

  Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)

Study Arms (2)

0.25% HL036 Ophthalmic Solution

EXPERIMENTAL

Participants self-administered HL036 0.25% ophthalmic solution as topical ophthalmic drops, twice daily (BID) for up to 8 weeks. Exposures to the controlled adverse environment (CAE®) were conducted at Day 1, Day 15, Day 29 and Day 57

Biological: HL036 Ophthalmic Solution

Placebo

PLACEBO COMPARATOR

Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.

Biological: Placebo

Interventions

HL036 Ophthalmic Solution BIOLOGICAL

HL036 Ophthalmic Solution

Also known as: Tanfanercept

0.25% HL036 Ophthalmic Solution

Placebo BIOLOGICAL

Placebo vehicle solution

Placebo

Eligibility Criteria

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

You may qualify if:

• Have a patient-reported history of dry eye for at least 6 months prior to Visit 1
• Be willing and able to comply with all study procedures
• Have a Schirmer's Test score of ≤ 10 mm and ≥ 1 mm at Visits 1 and 2

You may not qualify if:

• 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 any previous experience using HL036

Sponsors & Collaborators

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

Study Sites (12)

Cornea and Cataract Consultants of Arizona

Phoenix, Arizona, 85032, United States

Location

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

East West Eye Institute

Torrance, California, 90505, United States

Location

Specialty Retina Center

Boynton Beach, Florida, 33437, United States

Location

Specialty Retina Center

Coral Springs, Florida, 33067, United States

Location

Eye Care Centers Management Inc

Morrow, Georgia, 30260, United States

Location

MidWest Cornea Associates, LLC

Indianapolis, Indiana, 46290, United States

Location

The Eye Care Institute

Louisville, Kentucky, 40206, United States

Location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

Andover Eye Associates

Raynham, Massachusetts, 02767, United States

Location

Vita Eye Clinic

Shelby, North Carolina, 28150, United States

Location

Total Eye Care, P A

Memphis, Tennessee, 38119, United States

Location

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: Yes

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: February 17, 2019
• First Posted: February 19, 2019
• Study Start: March 10, 2019
• Primary Completion: November 22, 2019
• Study Completion: November 22, 2019
• Last Updated: April 14, 2022
• Results First Posted: April 14, 2022

Record last verified: 2022-02

Locations

US (12)