Dry EyePhase 3VELOS-3NCT05109702
A Study to Assess the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution in Participants With Dry Eye
A Phase 3 study testing 0.25% Tanfanercept Ophthalmic Solution in people with Dry Eye, run by HanAll BioPharma Co., Ltd. at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- 0.25% Tanfanercept Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 10 sitesUnited States
- Study dates
- 18 Nov 2021to 6 May 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, 16066
Oculus Research, Inc.
Garner, North Carolina, 27529
Global Research Management
Glendale, California, 91204
Center For Sight
Henderson, Nevada, 89052
The Eye Care Institute - Butchertown Clinical Trials
Louisville, Kentucky, 40206
Eye Research Foundation, Inc.
Newport Beach, California, 92663
Cornea & Cataract Consultants of Arizona
Phoenix, Arizona, 85032
Andover Eye Associates: Raynham
Raynham, Massachusetts, 02767
Advancing Vision Research, LLC.
Smyrna, Tennessee, 37072
Andover Eye Associates: Warwick
Warwick, Rhode Island, 02886
About this study
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
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.
- Conditions
- Dry Eye
- Being tested
- 0.25% Tanfanercept Ophthalmic Solution, Placebo
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.25% Tanfanercept Ophthalmic SolutionDrug
Also called HL036
Tanfanercept ophthalmic solution.
PlaceboDrug
Placebo vehicle solution.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Run-in | Other | Participants self-administered placebo ocular drops, twice daily (BID) in both eyes for 14 days in the Placebo Run-in Period. Receives: Drug: Placebo |
| 0.25% Tanfanercept Ophthalmic Solution | Experimental | Participants self-administered tanfanercept 0.25 percent (%) ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. Receives: Drug: 0.25% Tanfanercept Ophthalmic Solution |
| Placebo | Placebo comparator | Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Central Corneal Staining Score (CCSS) at Day 57
CCSS was graded using the Ora Calibra® Corneal and Conjunctival Fluorescein Staining Scale. The Ora Calibra® Corneal and Conjunctival Staining Scale ranged 0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, and 4 = Severe; lower score indicated improvement.
Measured: Baseline, Day 57 (Week 8)
Change From Baseline in Eye Dryness Score (EDS) Assessed by Visual Analogue Scale at Day 57
Eye dryness score was scored on a Visual Analogue Scale (VAS) that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).
Measured: Baseline, Day 57 (Week 8)
Secondary outcomes (33)
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Central Region
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement.
Measured: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Superior Region
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement.
Measured: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Inferior Region
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement.
Measured: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Temporal Region
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement.
Measured: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Nasal Region
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement.
Measured: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Corneal Sum
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement. Fluorescein total staining score for corneal regions was derived as the sum of the reported scores for the inferior, superior, and central regions. Total score ranged between 0 to 12, and lower score indicated improvement.
Measured: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Conjunctival Sum
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement. Fluorescein total staining score for conjunctival regions was derived the sum of the reported scores for the nasal and temporal regions. Total score ranged between 0 to 8, and lower score indicated improvement.
Measured: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Total Staining
The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement. Fluorescein total staining score for corneal and conjunctival regions was derived as the sum of the reported scores for the inferior, superior, central, temporal, and nasal regions. Total score ranged between 0 to 20, and lower score indicated improvement.
Measured: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Central Region
The score for individual region was 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.
Measured: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Superior Region
The score for individual region was 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.
Measured: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Inferior Region
The score for individual region was 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.
Measured: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Temporal Region
The score for individual region was 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.
Measured: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Nasal Region
The score for individual region was 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.
Measured: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Corneal Sum
The score for individual region was 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. Lissamine Green total staining score for corneal regions was derived as the sum of the reported scores for the inferior, superior, and central regions. Total score ranged between 0 to 12,and lower score indicated improvement.
Measured: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Conjunctival Sum
The score for individual region was 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. Lissamine Green total staining score for conjunctival regions was derived as the sum of the reported scores for the nasal and temporal regions. Total score ranged between 0 to 8, and lower score indicated improvement.
Measured: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Total Staining
The score for individual region was 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. Lissamine Green total staining score for corneal and conjunctival regions was derived as the sum of the reported scores for the inferior, superior, central, nasal, and temporal regions. Total score ranged between 0 to 20, and lower score indicated improvement.
Measured: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Conjunctival Redness Score at Weeks 1, 2, 4, and 8
It was evaluated by the Ora Calibra® conjunctival redness scale for dry eye. The score ranged from 0 to 4 (0=none and 4=severe), where lower score indicated improvement.
Measured: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Schirmer's Test Score at Weeks 2, 4, and 8
The Schirmer test strip was placed in the lower temporal lid margin of each eye. Participants were instructed to close their eyes and after 5 minutes had elapsed, the length of moistened area of schirmer strip was recorded (millimeter [mm]) for each eye.
Measured: Baseline; Weeks 2, 4, and 8
Change From Baseline in Tear Film Break-up Time at Weeks 1, 2, 4, and 8
Sodium fluorescein solution was instilled into each eye and participants were instructed to blinked several times. The time it took to form micelles from the time that the eye is opened was noted.
Measured: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Burning/Stinging
Participants rated ocular symptom of burning/stinging by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).
Measured: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Foreign Body Sensation
Participants rated ocular symptom of foreign body sensation by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).
Measured: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Itching
Participants rated ocular symptom of itching by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).
Measured: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Blurred Vision
Participants rated ocular symptom of blurred vision by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).
Measured: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Eye Dryness
Participants rated ocular symptom of eye dryness by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).
Measured: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Photophobia
Participants rated ocular symptom of photophobia by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).
Measured: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Pain
Participants rated ocular symptom of pain by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).
Measured: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Ocular Surface Disease Index (OSDI) at Weeks 1, 2, 4, and 8
OSDI was a simple 12-question survey that rated the severity of the participant's dry eye disease based on the symptoms. Each question response ranged from 0 to 4, where 0 = None of the Time, 1 = Some of the Time, 2 = Half of the Time, 3 = Most of the Time, and 4 = All of the Time. Total OSDI score = (Sum of all answered questions) * 25/ (number of questions answered); which ranged from 0 to 100, with higher score representing greater disability.
Measured: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Ora Calibra® Ocular Discomfort Scale at Weeks 1, 2, 4, and 8
It was assessed by the Ora Calibra® ocular discomfort scale. The score ranged from 0 to 4 (0=none and 4=severe), where lower score indicated improvement.
Measured: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Burning Discomfort
Ora Calibra® ocular discomfort \& 4-symptom questionnaire for dry eye included rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging.
Participants rated the severity of burning at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity.
Measured: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Dryness Discomfort
Ora Calibra® ocular discomfort \& 4-symptom questionnaire for dry eye included rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging.
Participants rated the severity of dryness at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity.
Measured: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Grittiness Discomfort
Ora Calibra® ocular discomfort \& 4-symptom questionnaire for dry eye included rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging.
Participants rated the severity of grittiness at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity.
Measured: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Stinging Discomfort
Ora Calibra® ocular discomfort \& 4-symptom questionnaire for dry eye included rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging.
Participants rated the severity of stinging at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity.
Measured: Baseline; Weeks 1, 2, 4, and 8
Ora Calibra® Drop Comfort Assessment at Week 1
Ora Calibra® drop comfort scale ranged from 0 to 10. A score of 0 indicated comfortable and 10 indicated uncomfortable. Lower score indicated better comfort level. Immediately Upon Instillation, 1 Minute Post Instillation and 2 Minutes Post Instillation at Week 1
Measured: Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start18 Nov 2021
- Primary completion6 May 2022
- Study completion6 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- HanAll BioPharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daewoong Pharmaceutical Co. LTD.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109702
- Sponsor's protocol ID
- HL036-DED-US-P302
- Acronym
- VELOS-3
- Status last verified
- Oct 2023
- First submitted
- 27 Oct 2021
- Last updated
- 23 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mangwani-Mordani S, Goodman CF, Galor A. Novel Treatments for Chronic Ocular Surface Pain. Cornea. 2023 Mar 1;42(3):261-271. doi: 10.1097/ICO.0000000000003193. Epub 2022 Dec 19.
PubMed 36729473
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05109702
- Acronym / sponsor ID
- VELOS-3 / HL036-DED-US-P302
- Conditions
- Dry Eye
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- HanAll BioPharma Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Daewoong Pharmaceutical Co. LTD.
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 6 May 2022 (actual)
- Study completion
- 6 May 2022 (actual)
- First posted
- 5 Nov 2021 (actual)
- Results
- Posted 23 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo Run-in | Other | Drug: PlaceboParticipants self-administered placebo ocular drops, twice daily (BID) in both eyes for 14 days in the Placebo Run-in Period. |
| 0.25% Tanfanercept Ophthalmic Solution | Experimental | Drug: 0.25% Tanfanercept Ophthalmic SolutionParticipants self-administered tanfanercept 0.25 percent (%) ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.25% Tanfanercept Ophthalmic SolutionAlso: HL036Tanfanercept ophthalmic solution. | Drug | 0.25% Tanfanercept Ophthalmic Solution |
| PlaceboPlacebo vehicle solution. | Drug | Placebo, Placebo Run-in |
Primary outcome
Change From Baseline in Central Corneal Staining Score (CCSS) at Day 57
Time frame: Baseline, Day 57 (Week 8)
CCSS was graded using the Ora Calibra® Corneal and Conjunctival Fluorescein Staining Scale. The Ora Calibra® Corneal and Conjunctival Staining Scale ranged 0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, and 4 = Severe; lower score indicated improvement.
Change From Baseline in Eye Dryness Score (EDS) Assessed by Visual Analogue Scale at Day 57
Time frame: Baseline, Day 57 (Week 8)
Eye dryness score was scored on a Visual Analogue Scale (VAS) that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).
33 secondary outcomes
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Central Region
Time frame: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Superior Region
Time frame: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Inferior Region
Time frame: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Temporal Region
Time frame: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Nasal Region
Time frame: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Corneal Sum
Time frame: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Conjunctival Sum
Time frame: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Total Staining
Time frame: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Central Region
Time frame: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Superior Region
Time frame: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Inferior Region
Time frame: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Temporal Region
Time frame: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Nasal Region
Time frame: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Corneal Sum
Time frame: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Conjunctival Sum
Time frame: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Total Staining
Time frame: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Conjunctival Redness Score at Weeks 1, 2, 4, and 8
Time frame: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Schirmer's Test Score at Weeks 2, 4, and 8
Time frame: Baseline; Weeks 2, 4, and 8
Change From Baseline in Tear Film Break-up Time at Weeks 1, 2, 4, and 8
Time frame: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Burning/Stinging
Time frame: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Foreign Body Sensation
Time frame: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Itching
Time frame: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Blurred Vision
Time frame: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Eye Dryness
Time frame: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Photophobia
Time frame: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Pain
Time frame: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Ocular Surface Disease Index (OSDI) at Weeks 1, 2, 4, and 8
Time frame: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Ora Calibra® Ocular Discomfort Scale at Weeks 1, 2, 4, and 8
Time frame: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Burning Discomfort
Time frame: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Dryness Discomfort
Time frame: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Grittiness Discomfort
Time frame: Baseline; Weeks 1, 2, 4, and 8
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Stinging Discomfort
Time frame: Baseline; Weeks 1, 2, 4, and 8
Ora Calibra® Drop Comfort Assessment at Week 1
Time frame: Week 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36729473Mangwani-Mordani S, Goodman CF, Galor A. Novel Treatments for Chronic Ocular Surface Pain. Cornea. 2023 Mar 1;42(3):261-271. doi: 10.1097/ICO.0000000000003193. Epub 2022 Dec 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 0.25% Tanfanercept Ophthalmic Solution in people with Dry Eye, run by HanAll BioPharma Co., Ltd. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Central Corneal Staining Score (CCSS) at Day 57 (time frame: Baseline, Day 57 (Week 8)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05109702, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.