Phase 3 Completed N=1,108 Randomized Triple-blind Treatment

A Study to Assess Efficacy and Safety of HL036 in Subjects With Dry Eyes

Dry Eye Disease

Source: ClinicalTrials.gov NCT03846453 ↗

Enrolled (actual)

1,108

Serious AEs

1.4%

Results posted

Apr 2022

Primary outcomePrimary: Coprimary Endpoint: Change From Baseline in Inferior Corneal Fluorescein Staining Score to Day 57 (Pre- to Post-CAE) — 1.38; 1.31; -0.47; -0.52 score on a scale — p=0.1871

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

The objective of this study was to compare the safety and efficacy of 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 Fluorescein Staining Score to Day 57 (Pre- to Post-CAE)	1.38; 1.31; -0.47; -0.52	0.1871
PRIMARY Coprimary Endpoint: Change From Baseline in Ocular Discomfort Score to Day 57 (Pre-CAE)	2.61; 2.53; -0.47; -0.47	0.5549
SECONDARY Mean Change From Baseline in Fluorescein Staining (Inferior Region)	1.78; 1.84; 3.17; 3.15; 1.38; 1.31	—
SECONDARY Mean Change From Baseline in Fluorescein Staining (Superior Region)	1.81; 1.82; 2.19; 2.20; 0.39; 0.39	—
SECONDARY Mean Change From Baseline in Fluorescein Staining (Central Region)	1.40; 1.36; 1.63; 1.66; 0.22; 0.30	—
SECONDARY Mean Change From Baseline in Fluorescein Staining (Temporal Region)	1.62; 1.67; 1.94; 1.95; 0.33; 0.28	—
SECONDARY Mean Change From Baseline in Fluorescein Staining (Nasal Region)	1.71; 1.73; 2.10; 2.08; 0.39; 0.35	—
SECONDARY Mean Change From Baseline in Fluorescein Staining (Corneal Sum)	4.99; 5.01; 6.99; 7.01; 1.99; 2.00	—
SECONDARY Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum)	3.33; 3.40; 4.05; 4.03; 0.71; 0.63	—
SECONDARY Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal)	8.33; 8.41; 11.03; 11.04; 2.71; 2.63	—
SECONDARY Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region)	1.03; 1.12; 1.71; 1.72; 0.67; 0.60	—
SECONDARY Mean Change From Baseline in Lissamine Green Staining Score (Superior Region)	0.81; 0.82; 0.96; 0.98; 0.15; 0.17	—
SECONDARY Mean Change From Baseline in Lissamine Green Staining Score (Central Region)	0.39; 0.39; 0.55; 0.57; 0.15; 0.18	—
SECONDARY Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region)	1.29; 1.35; 1.47; 1.55; 0.18; 0.21	—
SECONDARY Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region)	1.51; 1.48; 1.80; 1.82; 0.29; 0.34	—
SECONDARY Mean Change From Baseline in Lissamine Green Staining (Corneal Sum)	2.24; 2.33; 3.22; 3.27; 0.98; 0.95	—
SECONDARY Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum)	2.81; 2.83; 3.28; 3.37; 0.47; 0.54	—
SECONDARY Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal)	5.04; 5.15; 6.49; 6.64; 1.45; 1.49	—
SECONDARY Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale	1.53; 1.55; 1.89; 1.95; 0.36; 0.40	—
SECONDARY Change From Baseline in Schirmer's Test	5.1; 4.9; 1.2; 2.0; 2.0; 1.2	—
SECONDARY Change From Baseline in Tear Film Break-Up Time	2.482; 2.588; 2.444; 2.504; -0.037; -0.084	—
SECONDARY Change From Baseline in Ocular Surface Disease Index (OSDI)	39.7; 39.2; -2.0; -1.5; -2.7; -1.5	—
SECONDARY Change From Baseline in Visual Analog Scale (Blurry Vision)	37.8; 32.9; 43.7; 40.5; 5.9; 7.6	—
SECONDARY Change From Baseline in Visual Analog Scale (Burning/Stinging)	36.6; 35.6; 49.2; 47.1; 12.6; 11.5	—
SECONDARY Change From Baseline in Visual Analog Scale (Itching)	35.9; 35.6; 42.3; 39.6; 6.5; 4.0	—
SECONDARY Change From Baseline in Visual Analog Scale (Foreign Body Sensation)	37.8; 36.6; 47.5; 42.9; 9.7; 6.3	—
SECONDARY Change From Baseline in Visual Analog Scale (Eye Dryness)	61.4; 59.7; 74.4; 72.4; 13.1; 12.7	—
SECONDARY Change From Baseline in Visual Analog Scale (Photophobia)	40.4; 37.8; 46.0; 43.5; 5.6; 5.7	—
SECONDARY Change From Baseline in Visual Analog Scale (Pain)	27.7; 26.2; 39.3; 37.0; 11.6; 10.8	—
SECONDARY Change From Baseline in Ocular Discomfort Scale	2.6; 2.5; 3.6; 3.6; 1.0; 1.1	—
SECONDARY Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort)	2.8; 2.8; 3.7; 3.7; 0.9; 0.9	—
SECONDARY Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning)	1.7; 1.7; 2.6; 2.6; 0.9; 0.9	—
SECONDARY Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness)	3.2; 3.2; 3.9; 3.9; 0.8; 0.8	—
SECONDARY Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness)	2.1; 2.1; 2.7; 2.6; 0.6; 0.5	—
SECONDARY Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging)	1.6; 1.6; 2.3; 2.4; 0.8; 0.8	—
SECONDARY Ora Calibra® Drop Comfort Scale	3.5; 3.5; 2.5; 2.5; 2.1; 2.0	—
SECONDARY Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort)	2.7; 2.7; -0.1; -0.1; -0.2; -0.1	—
SECONDARY Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning)	1.9; 1.8; -0.1; -0.1; -0.2; -0.2	—
SECONDARY Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness)	3.0; 2.9; -0.1; -0.1; -0.3; -0.2	—
SECONDARY Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness)	2.1; 2.0; -0.2; -0.1; -0.3; -0.2	—
SECONDARY Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging)	1.7; 1.7; -0.1; -0.1; -0.3; -0.2	—

Eligibility Criteria

Inclusion Criteria

Have a patient-reported history of dry eye for at least 6 months prior to Visit 1
Be willing and able to comply with all study procedures
Have 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 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 any previous experience using HL036

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03846453). 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.