A Study to Assess Efficacy and Safety of HL036 in Subjects With Dry Eyes (VELOS-2)

HanAll Biopharma

Status and phase: Completed; Phase 3

Conditions: Dry Eye

Treatments: Biological: Placebo; Biological: HL036 Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT03846453

HL036-DED-US-P301

Details and patient eligibility

About

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.

Enrollment: 637 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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637 participants in 2 patient groups, including a placebo group

0.25% HL036 Ophthalmic Solution

Experimental group

Description:

Participants self-administered HL036 0.25% ophthalmic solution as topical ophthalmic drops, twice daily (BID) for up to 8 weeks. Exposures to the controlled adverse environment (CAE®) were conducted at Day 1, Day 15, Day 29 and Day 57

Treatment:

Biological: HL036 Ophthalmic Solution

Placebo

Placebo Comparator group

Description:

Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.

Treatment:

Biological: Placebo