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NCT Number: NCT01804361

Efficacy and Safety Study of Haporine-S for Treatment of Moderate to Severe Dry Eye Syndromes

The purpose of this study is to determine efficacy and safety of Haporine-S eye drop for the patients with moderate to severe dry eye disease in a multicenter phase III clinical trial.

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Busan National University Hospital, Busan, South Korea

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About this study

This study is to compare the efficacy and the safety of topical Haposine-S and Restasis® eye drop 0.05% for the patients with moderate to severe dry eye disease in a multicenter, investigator(assessor) blind, parallel design, non-inferiority phase III trial.

Primary outcome is the change of corneal staining score(Oxford scheme) at 12 weeks from baseline.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, age 20 or over
  • Patients with moderate to severe dry eye(DEWS Level II or over)
  • Be informed of the nature of the study and will give written informed consent

Exclusion criteria

  • Being treated with steroidal eye drop or non-steroidal anti-inflammatory eye drop for dry eye
  • Being treated with systemic steroid or immunosuppressive
  • History of eyeball surgical operation within 6 months
  • Wearing contact lenses during participation of the study
  • Pregnancy or breastfeeding
  • Use of cyclosporine eye drop within 2 weeks
  • Intraocular pressure(IOP)> 25 mmHg
  • History of punctal occlusion within 1 month or during participation of the study
  • Hypersensitivity to the investigational products or be suspicious to them
  • Patients whom the investigator considers inappropriate to participate in the study

Treatment and study plan

Haporine-S

Drug

1 or 2 drops twice a day at 12 hour interval for 12 weeks

Restasis (cyclosporine 0.05%)

Drug

1 or 2 drops twice a day at 12 hour interval for 12 weeks

Primary outcomes

  1. Corneal staining

    Time frame: up to 12 weeks

    Corneal fluorescein staining will be assessed at 0 day(baseline), 4 weeks and 12 weeks.

Secondary outcomes

  1. Ocular Surface Disease Index(OSID)

    Time frame: 0 day, 4 weeks and 12 weeks

    Ocular Surface Disease Index(OSID) will be assessed at 0 day, 4 weeks and 12 weeks.

  2. Tear Breakup Time(TBUT)

    Time frame: 0 day, 4 weeks and 12 weeks

    Tear Breakup Time(TBUT) will be assessed at 0 day(baseline), 4 weeks and 12 weeks.

  3. Schirmer score

    Time frame: 0 day, 4 weeks and 12 weeks

    Schirmer score will be assessed at 0 day(baseline), 4 weeks and 12 weeks.

  4. Drug compliance

    Time frame: 0 day, 4 weeks and 12 weeks

    Drug compliance(conjunctival hyperemia and burning etc) will be assessed at 0 day(baseline), 4 weeks and 12 weeks.

  5. DEWS(Dry Eye WorkShop) level

    Time frame: 0 day, 4 weeks and 12 weeks

    Level on dry eye severity grading scheme of DEWS will be assessed at 0 day(baseline), 4 weeks and 12 weeks.

Other outcomes

  1. Adverse Events

    Time frame: 1 year

    Adverse Event will be assessed for the whole study period(1 year).

  2. Serious Adverse Events

    Time frame: 1 year

    Serious Adverse Event will be assessed for the whole study period(1 year).

Sponsors and collaborators

Lead sponsor

DH Bio Co., Ltd.

Industry

Collaborators

  • BTO Pharm. Co., Ltd.

Registry information

Official study title

Efficacy and Safety Study of Haporine-S in Subjects With Moderate to Severe Dry Eye, A Multicenter, Investigator(Assessor)Blind, Parallel Design, Non-inferiority Phase III Trial

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 5, 2013
Registry last updated
Jul 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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