VELOS-3: A Study to Assess the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution in Participants With Dry Eye
Study Details
Study Description
Brief Summary
The objective of this study is 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 0.25% HL036 Ophthalmic Solution Participants self-administered HL036 0.25 percent (%) ophthalmic solution as topical ophthalmic drops, twice daily (BID) for 8 weeks. |
Drug: 0.25% HL036 Ophthalmic Solution
HL036 ophthalmic solution.
Other Names:
|
| Placebo Comparator: Placebo Participants self-administered HL036 placebo matching vehicle solution as topical ophthalmic drops, BID for 8 weeks. |
Drug: Placebo
Placebo vehicle solution.
|
Outcome Measures
Primary Outcome Measures
- Change from Baseline in Central Corneal Staining Score (CCSS) at Day 57 [Baseline, Day 57]
The CCSS will be assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement.
- Change from Baseline in Eye Dryness Score (EDS) Assessed by Visual Analogue Scale at Day 57 [Baseline, Day 57]
The participants will be asked to rate the symptom of ocular dryness by placing a vertical mark on the horizontal line to indicate the current level of discomfort. 0% corresponds to "no discomfort" and 100% corresponds to "maximal discomfort."
Secondary Outcome Measures
- Change from Baseline in Fluorescein Staining by Region (Central, Superior, Inferior, Temporal, Nasal, Corneal sum, Conjunctival Sum and Total staining) at Weeks 1, 2, 4, and 8 [Baseline; Weeks 1, 2, 4, and 8]
The score for individual region is assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Total score is sum of each region.
- Change from Baseline in Conjunctival Lissamine Green Staining by Region (Central, Superior, Inferior, Temporal, Nasal, Corneal sum, Conjunctival Sum and Total staining) at Weeks 1, 2, 4, and 8 [Baseline; Weeks 1, 2, 4, and 8]
The score for individual region is assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Total score is sum of each region.
- Change from Baseline in Conjunctival Redness Score at Weeks 1, 2, 4, and 8 [Baseline; Weeks 1, 2, 4, and 8]
It is evaluated by the Ora Calibra® conjunctival redness scale for dry eye. The score ranges from 0 to 4 (0=none and 4=severe), where lower score indicates improvement.
- Change from Baseline in Schirmer's Test Score at Weeks 2, 4, and 8 [Baseline; Weeks 2, 4, and 8]
The Schirmer test strip will be placed in the lower temporal lid margin of each eye. Participants will be instructed to close their eyes, and after 5 minutes have elapsed, the length of moistened area of schirmer strip will be recorded (mm) for each eye.
- Change from Baseline in Tear Film Break-up Time at Weeks 1, 2, 4, and 8 [Baseline; Weeks 1, 2, 4, and 8]
Sodium fluorescein solution will be instilled into each eye and participants will be instructed to blink several times. The time it takes to form micelles from the time that the eye is opened will be noted.
- Change from Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 [Baseline; Weeks 1, 2, 4, and 8]
Participants will be asked the questions regarding ocular discomfort (unrelated to study drug instillation). The participant will be asked to rate each ocular symptom due to ocular dryness by placing a vertical mark on the horizontal line to indicate the current level of discomfort. 0% corresponds to "no discomfort" and 100% corresponds to "maximal discomfort.
- Change from Baseline in Ocular Surface Disease Index (OSDI) at Weeks 1, 2, 4, and 8 [Baseline; Weeks 1, 2, 4, and 8]
The OSDI is a simple 12-question survey that rates the severity of your dry eye disease based on your symptoms. It is assessed on a scale of 0 to 100, with higher score representing greater disability.
- Change from Baseline in Ora Calibra® Ocular Discomfort Scale at Weeks 1, 2, 4, and 8 [Baseline; Weeks 1, 2, 4, and 8]
It is assessed by the Ora Calibra® ocular discomfort scale. The score ranges from 0 to 4 (0=none and 4=severe), where lower score indicates improvement.
- Change from Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 [Baseline; Weeks 1, 2, 4, and 8]
Participants will rate the severity of each of the following symptoms, with regards to how they feel in both eyes - overall ocular discomfort, burning, dryness, grittiness, and stinging on 0 to 5 scale, where 0=none and 5=severe.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Have a participant-reported history of dry eye for at least 6 months prior to Visit 1
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Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1
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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
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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
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Have a Schirmer's Test score of ≤ 10 mm and ≥ 1 mm in at least one eye at Visits 1 and 2
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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
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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:
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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
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Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1
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Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study
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Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months
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Have used any cyclosporine-containing drops (such as Restasis®, Cequa®), or lifitegrast ophthalmic solution (Xiidra®) within 60 days of Visit 1
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Have any previous experience using tanfanercept ophthalmic solution
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cornea & Cataract Consultants of Arizona | Phoenix | Arizona | United States | 85032 |
| 2 | Global Research Management | Glendale | California | United States | 91204 |
| 3 | Eye Research Foundation, Inc. | Newport Beach | California | United States | 92663 |
| 4 | The Eye Care Institute - Butchertown Clinical Trials | Louisville | Kentucky | United States | 40206 |
| 5 | Andover Eye Associates: Raynham | Raynham | Massachusetts | United States | 02767 |
| 6 | Center For Sight | Henderson | Nevada | United States | 89052 |
| 7 | Oculus Research, Inc. | Garner | North Carolina | United States | 27529 |
| 8 | Scott & Christie and Associates, PC | Cranberry Township | Pennsylvania | United States | 16066 |
| 9 | Andover Eye Associates: Warwick | Warwick | Rhode Island | United States | 02886 |
| 10 | Advancing Vision Research, LLC. | Smyrna | Tennessee | United States | 37072 |
Sponsors and Collaborators
- HanAll BioPharma Co., Ltd.
- Daewoong Pharmaceutical Co. LTD.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HL036-DED-US-P302