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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03846453
Recruitment Status : Recruiting
First Posted : February 19, 2019
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
Daewoong Pharmaceutical Co. LTD.
Information provided by (Responsible Party):
HanAll BioPharma Co., Ltd.

Study Description
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Brief Summary:
The objective of this study is 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.

Condition or disease Intervention/treatment Phase
Dry Eye Biological: 0.25% HL036 Ophthalmic Solution Biological: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 630 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Efficacy and Safety of 0.25% HL036 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye
Actual Study Start Date : March 10, 2019
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : December 31, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: 0.25% HL036 Ophthalmic Solution
HL036 ophthalmic solution
 Biological: 0.25% HL036 Ophthalmic Solution
0.25% HL036 Ophthalmic Solution consists of all components of the drug product solution with 0.25% Active Pharmaceutical Ingredient (API)
Placebo Comparator: Placebo
Placebo vehicle solution
 Biological: Placebo
The placebo solution consists of all components of the drug product solution with the exception of API


Outcome Measures
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Primary Outcome Measures :
  1. Mean change from baseline to Visit 6 of Inferior Corneal and Conjunctival Staining Scale(ICSS) [ Time Frame: 8weeks ]
  2. Mean change from baseline to Visit 6 of Ocular Discomfort Scale(ODS) [ Time Frame: 8weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03846453


Contacts
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Contact: Joohyun Chae hpi-usa@hanall.co.kr

Locations
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United States, Indiana
MidWest Cornea Associates, LLC Not yet recruiting
Indianapolis, Indiana, United States, 46290
Contact: Blair Boehmer, M.D.         
United States, Kentucky
The Eye Care Institute Not yet recruiting
Louisville, Kentucky, United States, 40206
Contact: Guruprasad Pattar, M.D.         
United States, Massachusetts
Andover Eye Associates Recruiting
Andover, Massachusetts, United States, 01810
Contact: Gail Torkildsen, M.D.         
Sponsors and Collaborators
HanAll BioPharma Co., Ltd.
Daewoong Pharmaceutical Co. LTD.
More Information
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Responsible Party: HanAll BioPharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT03846453    
Other Study ID Numbers: HL036-DED-US-P301
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
 Conjunctival Diseases
Keratitis
Corneal Diseases
Ophthalmic Solutions
Pharmaceutical Solutions