Phase 2
Completed N=150
A Study to Assess Efficacy of HL036 in Subjects With Dry Eyes
Source: ClinicalTrials.gov NCT03334539 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcomePrimary: Coprimary Endpoint: Change From Baseline in Inferior Corneal Staining Score to Day 57 (Pre-CAE) — 1.94; 1.96; 1.95; 0.10 score on a scale — p=0.3378
Summary
The objective of this study was to compare the safety and efficacy of 0.10% and 0.25% HL036 Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Coprimary Endpoint: Change From Baseline in Inferior Corneal Staining Score to Day 57 (Pre-CAE) |
1.94; 1.96; 1.95; 0.10; 0.10; -0.02 | 0.3378 |
| PRIMARY Coprimary Endpoint: Change From Baseline in Ocular Discomfort Score to Day 57 (Pre-CAE) |
2.6; 2.5; 2.4; -0.5; -0.4; -0.1 | 0.1473 |
| SECONDARY Mean Change From Baseline in Fluorescein Staining (Inferior Region) |
1.94; 1.96; 1.95; 3.32; 3.25; 3.20 | — |
| SECONDARY Mean Change From Baseline in Fluorescein Staining (Superior Region) |
2.05; 2.08; 2.03; 2.69; 2.56; 2.45 | — |
| SECONDARY Mean Change From Baseline in Fluorescein Staining (Central Region) |
1.45; 1.57; 1.49; 2.22; 2.09; 2.04 | — |
| SECONDARY Mean Change From Baseline in Fluorescein Staining (Temporal Region) |
2.14; 2.12; 2.02; 2.60; 2.42; 2.47 | — |
| SECONDARY Mean Change From Baseline in Fluorescein Staining (Nasal Region) |
2.27; 2.26; 2.14; 2.74; 2.67; 2.68 | — |
| SECONDARY Mean Change From Baseline in Fluorescein Staining (Corneal Sum) |
5.44; 5.61; 5.47; 8.23; 7.90; 7.69 | — |
| SECONDARY Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) |
4.41; 4.38; 4.16; 5.34; 5.09; 5.15 | — |
| SECONDARY Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) |
9.85; 9.99; 9.63; 13.57; 12.99; 12.84 | — |
| SECONDARY Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) |
1.42; 1.46; 1.50; 2.00; 2.12; 1.87 | — |
| SECONDARY Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) |
1.22; 1.32; 1.27; 1.48; 1.51; 1.44 | — |
| SECONDARY Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) |
0.48; 0.57; 0.54; 0.59; 0.60; 0.66 | — |
| SECONDARY Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) |
1.63; 1.63; 1.61; 1.87; 1.71; 1.87 | — |
| SECONDARY Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) |
1.90; 1.96; 1.69; 2.18; 2.05; 1.93 | — |
| SECONDARY Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) |
3.12; 3.35; 3.31; 4.07; 4.23; 3.97 | — |
| SECONDARY Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) |
3.53; 3.59; 3.30; 4.05; 3.76; 3.80 | — |
| SECONDARY Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) |
6.65; 6.94; 6.61; 8.12; 7.99; 7.77 | — |
| SECONDARY Change From Baseline in Tear Film Break-Up Time |
1.559; 1.709; 1.574; 1.533; 1.555; 1.574 | — |
| SECONDARY Change From Baseline in the Ora Calibra® Conjunctival Redness Scale |
1.70; 1.66; 1.72; 2.03; 2.02; 2.04 | — |
| SECONDARY Change From Baseline in Schirmer's Test |
5.0; 5.2; 5.5; 1.7; 4.0; 3.4 | — |
| SECONDARY Change From Baseline in Ora Calibra® Ocular Discomfort Scale |
2.6; 2.5; 2.4; 3.8; 3.7; 3.8 | — |
| SECONDARY Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) |
2.9; 2.7; 2.8; 3.8; 3.7; 4.0 | — |
| SECONDARY Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) |
1.6; 1.4; 1.2; 2.5; 2.3; 2.4 | — |
| SECONDARY Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) |
3.1; 3.1; 3.0; 4.0; 3.9; 4.1 | — |
| SECONDARY Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) |
2.1; 1.8; 2.0; 2.7; 2.3; 3.0 | — |
| SECONDARY Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) |
1.5; 1.2; 1.0; 2.3; 1.9; 2.0 | — |
| SECONDARY Change From Baseline in Visual Analog Scale (Burning) |
30.4; 29.3; 22.4; 44.6; 44.1; 40.1 | — |
| SECONDARY Change From Baseline in Visual Analog Scale (Itching) |
28.6; 26.2; 26.8; 37.0; 31.9; 35.0 | — |
| SECONDARY Change From Baseline in Visual Analog Scale (Foreign Body) |
35.3; 35.1; 34.1; 45.1; 43.1; 49.9 | — |
| SECONDARY Change From Baseline in Visual Analog Scale (Blurred Vision) |
18.5; 24.0; 26.9; 26.4; 32.2; 41.1 | — |
| SECONDARY Change From Baseline in Visual Analog Scale (Dryness) |
57.7; 58.6; 58.0; 74.2; 71.8; 75.0 | — |
| SECONDARY Change From Baseline in Visual Analog Scale (Photophobia) |
32.8; 37.4; 36.7; 38.1; 39.8; 49.7 | — |
| SECONDARY Change From Baseline in Visual Analog Scale (Pain) |
17.0; 17.8; 17.4; 29.1; 26.3; 27.1 | — |
| SECONDARY Change From Baseline in Ocular Surface and Disease Index (OSDI©) |
32.45; 36.78; 38.08; -1.57; -0.87; -3.79 | — |
| SECONDARY Ora Calibra® Drop Comfort Scale |
2.8; 3.6; 3.3; 2.0; 2.6; 2.3 | — |
| SECONDARY Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) |
2.74; 2.82; 2.66; -0.13; -0.09; -0.07 | — |
| SECONDARY Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) |
1.72; 1.49; 1.50; -0.13; -0.08; -0.07 | — |
| SECONDARY Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) |
2.88; 2.96; 2.99; -0.13; -0.11; -0.10 | — |
| SECONDARY Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) |
2.14; 1.84; 2.07; -0.19; -0.07; -0.03 | — |
| SECONDARY Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) |
1.53; 1.20; 1.26; -0.14; -0.13; -0.11 | — |
Eligibility Criteria
Inclusion Criteria
- Have a patient-reported history of dry eye for at least 6 months prior to enrollment
- Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1
- Have in the study eye 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 used Restasis® or Xiidra® within 60 days of Visit 1
- 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)
- Have an uncontrolled systemic disease
- Be a woman who is pregnant, nursing or planning a pregnancy
Data sourced from ClinicalTrials.gov (NCT03334539). 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. Informational only — not medical advice.