Clinical trial NCT05109702: A Study to Assess the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution in Participants With Dry Eye
Official title: A Phase 3, Multicenter, Randomized, Double Masked and Placebo-Controlled Study Evaluating the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution 0.25% 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: 2021-11-05
Enrollment: 260
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 tanfanercept ophthalmic solution 0.25% with placebo for the treatment of the signs and symptoms of dry eye.


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

Primary outcomes:
measure: Change From Baseline in Central Corneal Staining Score (CCSS) at Day 57
timeFrame: Baseline, Day 57 (Week 8)
measure: Change From Baseline in Eye Dryness Score (EDS) Assessed by Visual Analogue Scale at Day 57
timeFrame: Baseline, Day 57 (Week 8)
Secondary outcomes:
measure: Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Central Region
timeFrame: Baseline; Weeks 1, 2, 4, and 8
measure: Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Superior Region
timeFrame: Baseline; Weeks 1, 2, 4, and 8
measure: Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Inferior Region
timeFrame: Baseline; Weeks 1, 2, 4, and 8
measure: Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Temporal Region
timeFrame: Baseline; Weeks 1, 2, 4, and 8
measure: Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Nasal Region
timeFrame: Baseline; Weeks 1, 2, 4, and 8
measure: Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Corneal Sum
timeFrame: Baseline; Weeks 1, 2, 4, and 8
measure: Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Conjunctival Sum
timeFrame: Baseline; Weeks 1, 2, 4, and 8
measure: Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Total Staining
timeFrame: Baseline; Weeks 1, 2, 4, and 8
measure: Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Central Region
timeFrame: Baseline; Weeks 1, 2, 4, and 8
measure: Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Superior Region
timeFrame: Baseline; Weeks 1, 2, 4, and 8
measure: Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Inferior Region
timeFrame: Baseline; Weeks 1, 2, 4, and 8
measure: Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Temporal Region
timeFrame: Baseline; Weeks 1, 2, 4, and 8
measure: Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Nasal Region
timeFrame: Baseline; Weeks 1, 2, 4, and 8
measure: Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Corneal Sum
timeFrame: Baseline; Weeks 1, 2, 4, and 8
measure: Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Conjunctival Sum
timeFrame: Baseline; Weeks 1, 2, 4, and 8
measure: Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Total Staining
timeFrame: Baseline; Weeks 1, 2, 4, and 8
measure: Change From Baseline in Conjunctival Redness Score at Weeks 1, 2, 4, and 8
timeFrame: Baseline; Weeks 1, 2, 4, and 8
measure: Change From Baseline in Schirmer's Test Score at Weeks 2, 4, and 8
timeFrame: Baseline; Weeks 2, 4, and 8
measure: Change From Baseline in Tear Film Break-up Time at Weeks 1, 2, 4, and 8
timeFrame: Baseline; Weeks 1, 2, 4, and 8
measure: Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Burning/Stinging
timeFrame: Baseline; Weeks 1, 2, 4, and 8
measure: Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Foreign Body Sensation
timeFrame: Baseline; Weeks 1, 2, 4, and 8
measure: Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Itching
timeFrame: Baseline; Weeks 1, 2, 4, and 8
measure: Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Blurred Vision
timeFrame: Baseline; Weeks 1, 2, 4, and 8
measure: Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Eye Dryness
timeFrame: Baseline; Weeks 1, 2, 4, and 8
measure: Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Photophobia
timeFrame: Baseline; Weeks 1, 2, 4, and 8
measure: Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Pain
timeFrame: Baseline; Weeks 1, 2, 4, and 8
measure: Change From Baseline in Ocular Surface Disease Index (OSDI) at Weeks 1, 2, 4, and 8
timeFrame: Baseline; Weeks 1, 2, 4, and 8
measure: Change From Baseline in Ora Calibra® Ocular Discomfort Scale at Weeks 1, 2, 4, and 8
timeFrame: Baseline; Weeks 1, 2, 4, and 8
measure: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Burning Discomfort
timeFrame: Baseline; Weeks 1, 2, 4, and 8
measure: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Dryness Discomfort
timeFrame: Baseline; Weeks 1, 2, 4, and 8
measure: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Grittiness Discomfort
timeFrame: Baseline; Weeks 1, 2, 4, and 8
measure: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Stinging Discomfort
timeFrame: Baseline; Weeks 1, 2, 4, and 8
measure: Ora Calibra® Drop Comfort Assessment at Week 1
timeFrame: Week 1
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Cornea & Cataract Consultants of Arizona
state: Arizona
city: Glendale
country: United States
facility: Global Research Management
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation, Inc.
state: California
city: Louisville
country: United States
facility: The Eye Care Institute - Butchertown Clinical Trials
state: Kentucky
city: Raynham
country: United States
facility: Andover Eye Associates: Raynham
state: Massachusetts
city: Henderson
country: United States
facility: Center For Sight
state: Nevada
city: Garner
country: United States
facility: Oculus Research, Inc.
state: North Carolina
city: Cranberry Township
country: United States
facility: Scott & Christie and Associates, PC
state: Pennsylvania
city: Warwick
country: United States
facility: Andover Eye Associates: Warwick
state: Rhode Island
city: Smyrna
country: United States
facility: Advancing Vision Research, LLC.
state: Tennessee
Study officials:
References: