Phase 3
N=260
A Study to Assess the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution in Participants With Dry Eye
Dry Eye
Bottom Line
View on ClinicalTrials.gov: NCT05109702 ↗Enrolled (actual)
260
Serious AEs
0.2%
Results posted
Oct 2023
Primary outcome: Primary: Change From Baseline in Central Corneal Staining Score (CCSS) at Day 57 — 2.40; 2.37; -0.82; -0.79 score on a scale — p=0.764
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 0.25% Tanfanercept Ophthalmic Solution (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- HanAll BioPharma Co., Ltd.
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Central Corneal Staining Score (CCSS) at Day 57 |
2.40; 2.37; -0.82; -0.79 | 0.764 |
| PRIMARY Change From Baseline in Eye Dryness Score (EDS) Assessed by Visual Analogue Scale at Day 57 |
66.1; 60.8; -16.19; -19.79 | 0.144 |
| SECONDARY Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Central Region |
-0.43; -0.59; -0.45; -0.61; -0.57; -0.64 | 0.056 |
| SECONDARY Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Superior Region |
-0.21; -0.20; -0.22; -0.21; -0.25; -0.25 | 0.686 |
| SECONDARY Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Inferior Region |
-0.14; -0.13; -0.10; -0.24; -0.12; -0.15 | 0.765 |
| SECONDARY Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Temporal Region |
-0.16; -0.13; -0.14; -0.19; -0.17; -0.27 | 0.884 |
| SECONDARY Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Nasal Region |
-0.12; -0.16; -0.17; -0.23; -0.19; -0.27 | 0.604 |
| SECONDARY Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Corneal Sum |
-0.78; -0.91; -0.76; -1.06; -0.94; -1.04 | 0.293 |
| SECONDARY Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Conjunctival Sum |
-0.28; -0.29; -0.31; -0.42; -0.36; -0.54 | 0.824 |
| SECONDARY Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Total Staining |
-1.07; -1.20; -1.07; -1.48; -1.30; -1.58 | 0.430 |
| SECONDARY Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Central Region |
0.01; -0.16; -0.13; -0.25; -0.24; -0.30 | 0.016 sig |
| SECONDARY Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Superior Region |
-0.11; -0.12; -0.20; -0.17; -0.25; -0.22 | 0.655 |
| SECONDARY Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Inferior Region |
-0.07; -0.14; -0.06; -0.33; -0.25; -0.27 | 0.527 |
| SECONDARY Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Temporal Region |
-0.02; -0.18; -0.17; -0.25; -0.23; -0.31 | 0.071 |
| SECONDARY Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Nasal Region |
-0.13; -0.10; -0.25; -0.35; -0.19; -0.24 | 0.884 |
| SECONDARY Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Corneal Sum |
-0.17; -0.42; -0.39; -0.75; -0.74; -0.79 | 0.131 |
| SECONDARY Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Conjunctival Sum |
-0.14; -0.29; -0.42; -0.60; -0.42; -0.54 | 0.324 |
| SECONDARY Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Total Staining |
-0.32; -0.71; -0.81; -1.35; -1.16; -1.33 | 0.140 |
| SECONDARY Change From Baseline in Conjunctival Redness Score at Weeks 1, 2, 4, and 8 |
-0.10; -0.08; -0.14; -0.19; -0.13; -0.22 | 0.784 |
| SECONDARY Change From Baseline in Schirmer's Test Score at Weeks 2, 4, and 8 |
0.69; 0.31; 1.24; 0.56; 2.45; 0.51 | 0.532 |
| SECONDARY Change From Baseline in Tear Film Break-up Time at Weeks 1, 2, 4, and 8 |
0.45; 0.55; 0.17; 0.42; 0.16; 0.57 | 0.723 |
| SECONDARY Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Burning/Stinging |
-7.49; -5.43; -8.74; -9.66; -11.84; -9.04 | 0.615 |
| SECONDARY Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Foreign Body Sensation |
-4.63; -4.06; -7.93; -8.26; -7.83; -6.90 | 0.343 |
| SECONDARY Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Itching |
-6.49; -5.52; -8.39; -9.07; -10.31; -9.78 | 0.754 |
| SECONDARY Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Blurred Vision |
-5.95; -7.53; -8.94; -8.61; -9.50; -9.49 | 0.110 |
| SECONDARY Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Eye Dryness |
-6.98; -9.23; -10.34; -12.52; -13.64; -13.12 | 0.136 |
| SECONDARY Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Photophobia |
-6.57; -3.56; -7.17; -5.54; -8.20; -9.10 | 0.861 |
| SECONDARY Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Pain |
-6.27; -5.63; -5.00; -7.25; -6.27; -8.27 | 0.613 |
| SECONDARY Change From Baseline in Ocular Surface Disease Index (OSDI) at Weeks 1, 2, 4, and 8 |
-3.13; -5.65; -4.85; -6.23; -4.54; -8.16 | 0.041 sig |
| SECONDARY Change From Baseline in Ora Calibra® Ocular Discomfort Scale at Weeks 1, 2, 4, and 8 |
-0.22; -0.31; -0.34; -0.41; -0.48; -0.39 | 0.282 |
| SECONDARY Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Burning Discomfort |
-0.44; -0.23; -0.42; -0.29; -0.56; -0.35 | 0.969 |
| SECONDARY Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Dryness Discomfort |
-0.34; -0.34; -0.43; -0.43; -0.60; -0.44 | 0.287 |
| SECONDARY Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Grittiness Discomfort |
-0.26; -0.29; -0.45; -0.56; -0.48; -0.38 | -0.198 |
| SECONDARY Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Stinging Discomfort |
-0.30; -0.31; -0.34; -0.52; -0.50; -0.50 | 0.477 |
| SECONDARY Ora Calibra® Drop Comfort Assessment at Week 1 |
2.55; 2.72; 1.95; 2.21; 1.56; 1.79 | 0.598 |
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
Data sourced from ClinicalTrials.gov (NCT05109702). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.