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

NCT03334539 | Completed Phase 2 Results FDA Drug

• 1 other identifier: HL036-DED-US-P201
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this study was to compare the safety and efficacy of 0.10% and 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 Staining Score to Day 57 (Pre-CAE)

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

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

• 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 (3)

0.10% HL036 Ophthalmic Solution

EXPERIMENTAL

Participants self-administered HL036 0.10 percent (%) 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

0.25% HL036 Ophthalmic Solution

EXPERIMENTAL

Participants self-administered HL036 0.25% ophthalmic 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: 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.

Other: Placebo vehicle solution

Interventions

HL036 ophthalmic solution BIOLOGICAL

HL036 ophthalmic solution

Also known as: Tanfanercept

0.10% HL036 Ophthalmic Solution; 0.25% HL036 Ophthalmic Solution

Placebo vehicle solution OTHER

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 enrollment
• Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1
• Have in the study eye 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 used Restasis® or Xiidra® within 60 days of Visit 1
• 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)
• Have an uncontrolled systemic disease
• Be a woman who is pregnant, nursing or planning a pregnancy

Sponsors & Collaborators

• HanAll BioPharma Co., Ltd.: lead

Study Sites (2)

Central Maine Eye Care

Lewiston, Maine, 04240, United States

Location

Andover Eye Associates

Andover, Massachusetts, 01810, 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

Study Officials

• Gail Torkildsen, MD

  Andover Eye Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: November 7, 2017
• Study Start: November 5, 2017
• Primary Completion: April 9, 2018
• Study Completion: April 9, 2018
• Last Updated: March 7, 2024
• Results First Posted: January 26, 2022

Record last verified: 2021-12

Locations

US (2)