Clinical trial NCT03846453: A Study to Assess Efficacy and Safety of HL036 in Subjects With Dry Eyes
Official title: A Phase 3, Multicenter, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Efficacy and Safety of 0.25% HL036 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye
Lead sponsor: HanAll BioPharma Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Daewoong Pharmaceutical Co. LTD.
First posted: 2019-02-19
Enrollment: 637
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Coprimary Endpoint: Change From Baseline in Inferior Corneal Fluorescein Staining Score to Day 57 (Pre- to Post-CAE)
timeFrame: Pre-CAE and Post-CAE on Day 1 (Baseline) and Day 57
measure: Coprimary Endpoint: Change From Baseline in Ocular Discomfort Score to Day 57 (Pre-CAE)
timeFrame: Baseline (Day 1 Pre-CAE), Day 57 (Pre-CAE)
Secondary outcomes:
measure: Mean Change From Baseline in Fluorescein Staining (Inferior Region)
timeFrame: 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)
measure: Mean Change From Baseline in Fluorescein Staining (Superior Region)
timeFrame: 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)
measure: Mean Change From Baseline in Fluorescein Staining (Central Region)
timeFrame: 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)
measure: Mean Change From Baseline in Fluorescein Staining (Temporal Region)
timeFrame: 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)
measure: Mean Change From Baseline in Fluorescein Staining (Nasal Region)
timeFrame: 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)
measure: Mean Change From Baseline in Fluorescein Staining (Corneal Sum)
timeFrame: 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)
measure: Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum)
timeFrame: 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)
measure: Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal)
timeFrame: 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)
measure: Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region)
timeFrame: 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)
measure: Mean Change From Baseline in Lissamine Green Staining Score (Superior Region)
timeFrame: 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)
measure: Mean Change From Baseline in Lissamine Green Staining Score (Central Region)
timeFrame: 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)
measure: Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region)
timeFrame: 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)
measure: Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region)
timeFrame: 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)
measure: Mean Change From Baseline in Lissamine Green Staining (Corneal Sum)
timeFrame: 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)
measure: Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum)
timeFrame: 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)
measure: Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal)
timeFrame: 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)
measure: Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale
timeFrame: 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)
measure: Change From Baseline in Schirmer's Test
timeFrame: Post CAE on baseline (Day 1) and Days 15, 29, and 57
measure: Change From Baseline in Tear Film Break-Up Time
timeFrame: 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)
measure: Change From Baseline in Ocular Surface Disease Index (OSDI)
timeFrame: Pre-CAE on baseline (Day 1) and Days 15, 29, and 57; Day 8
measure: Change From Baseline in Visual Analog Scale (Blurry Vision)
timeFrame: 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)
measure: Change From Baseline in Visual Analog Scale (Burning/Stinging)
timeFrame: 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)
measure: Change From Baseline in Visual Analog Scale (Itching)
timeFrame: 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)
measure: Change From Baseline in Visual Analog Scale (Foreign Body Sensation)
timeFrame: 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)
measure: Change From Baseline in Visual Analog Scale (Eye Dryness)
timeFrame: 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)
measure: Change From Baseline in Visual Analog Scale (Photophobia)
timeFrame: 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)
measure: Change From Baseline in Visual Analog Scale (Pain)
timeFrame: 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)
measure: Change From Baseline in Ocular Discomfort Scale
timeFrame: 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)
measure: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort)
timeFrame: 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)
measure: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning)
timeFrame: 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)
measure: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness)
timeFrame: 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)
measure: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness)
timeFrame: 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)
measure: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging)
timeFrame: 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)
measure: Ora Calibra® Drop Comfort Scale
timeFrame: Upon instillation and 1 and 2 minutes post-instillation on Day 1
measure: Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort)
timeFrame: From Day -14 to Day 56
measure: Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning)
timeFrame: From Day -14 to Day 56
measure: Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness)
timeFrame: From Day -14 to Day 56
measure: Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness)
timeFrame: From Day -14 to Day 56
measure: Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging)
timeFrame: From Day -14 to Day 56
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Cornea and Cataract Consultants of Arizona
state: Arizona
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Torrance
country: United States
facility: East West Eye Institute
state: California
city: Boynton Beach
country: United States
facility: Specialty Retina Center
state: Florida
city: Coral Springs
country: United States
facility: Specialty Retina Center
state: Florida
city: Morrow
country: United States
facility: Eye Care Centers Management Inc
state: Georgia
city: Indianapolis
country: United States
facility: MidWest Cornea Associates, LLC
state: Indiana
city: Louisville
country: United States
facility: The Eye Care Institute
state: Kentucky
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
city: Raynham
country: United States
facility: Andover Eye Associates
state: Massachusetts
city: Shelby
country: United States
facility: Vita Eye Clinic
state: North Carolina
city: Memphis
country: United States
facility: Total Eye Care, P A
state: Tennessee
Study officials:
References: