A Study to Assess Efficacy of HL036 in Subjects With Dry Eyes (VELOS-1)

HanAll Biopharma

Status and phase: Completed; Phase 2

Conditions: Dry Eye

Treatments: Biological: HL036 ophthalmic solution; Other: Placebo vehicle solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT03334539

HL036-DED-US-P201

Details and patient eligibility

About

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.

Enrollment: 150 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups, including a placebo group

0.10% HL036 Ophthalmic Solution

Experimental group

Description:

Participants self-administered HL036 0.10 percent (%) 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

0.25% HL036 Ophthalmic Solution

Experimental group

Description:

Participants self-administered HL036 0.25% ophthalmic 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: 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:

Other: Placebo vehicle solution