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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.

Tracking Information
First Submitted Date  ICMJE February 17, 2019
First Posted Date  ICMJE February 19, 2019
Last Update Posted Date March 13, 2019
Actual Study Start Date  ICMJE March 10, 2019
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2019)
  • Mean change from baseline to Visit 6 of Inferior Corneal and Conjunctival Staining Scale(ICSS) [ Time Frame: 8weeks ]
  • Mean change from baseline to Visit 6 of Ocular Discomfort Scale(ODS) [ Time Frame: 8weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 17, 2019)
  • Mean change from baseline to Visit 6 of ICSS on the Ora Calibra® scale [ Time Frame: 8weeks ]
  • Mean change from baseline to Visit 6 of ODS on the Ora Calibra® Ocular Discomfort Scale [ Time Frame: 8weeks ]
Change History Complete list of historical versions of study NCT03846453 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess Efficacy and Safety of HL036 in Subjects With Dry Eyes
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dry Eye
Intervention  ICMJE
  • 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)
  • Biological: Placebo
    The placebo solution consists of all components of the drug product solution with the exception of API
Study Arms  ICMJE
  • Experimental: 0.25% HL036 Ophthalmic Solution
    HL036 ophthalmic solution
    Intervention: Biological: 0.25% HL036 Ophthalmic Solution
  • Placebo Comparator: Placebo
    Placebo vehicle solution
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 17, 2019)
630
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Joohyun Chae hpi-usa@hanall.co.kr
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03846453
Other Study ID Numbers  ICMJE HL036-DED-US-P301
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party HanAll BioPharma Co., Ltd.
Study Sponsor  ICMJE HanAll BioPharma Co., Ltd.
Collaborators  ICMJE Daewoong Pharmaceutical Co. LTD.
Investigators  ICMJE Not Provided
PRS Account HanAll BioPharma Co., Ltd.
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP