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Completed

NCT Number: NCT02092207

Phase 2 Study to Evaluation the Safety and Efficacy of Orally Administered KL7016 in Patients With Dry Eye Syndrome

This is a controlled study to determine the effectiveness and safety of KL7016 in the treatment of adult patients with dry eye syndrome (DES).

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Key information

Conditions

Dry Eye Syndrome Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, Banpo-daero, Seocho-gu, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Corneal staining score of ≥5 in either eye by the National Eye Institute/Industry Workshop guidelines
  • Schirmer test score (without anesthesia) < 7 mm/5 min in either eye
  • Willing to use no topical ocular treatments, other than REFRESH TEARS® for the duration of the trial

Exclusion criteria

  • Intraocular surgery within 3months
  • Persistent intraocular inflammation or infection
  • Corneal transplantation or neurotrophic keratitis
  • Stevens-Johnson Syndrome
  • Ocular herpes simplex virus infection
  • Concomitant use of contact lenses or use within 3months
  • Silicone lacrimal punctal occlusion or cauterization of the punctum within 3months
  • Vision correction surgery without DES within 12months
  • Unstable use of methotrexate or Disease-modifying drugs

Treatment and study plan

KL7016 900mg

Drug

oral administration, 150mg 3tab, bid

KL7016 600mg

Drug

oral administration, 150mg 3tab, bid

Placebo

Drug

oral administration, 150mg 3tab, bid

Primary outcomes

  1. Change in corneal staining score

    Time frame: baseline, 12 weeks

Secondary outcomes

  1. Change in schirmer test score

    Time frame: baseline, 4weeks, 8weeks, 12 weeks

  2. Change in OSDI(Ocular Surface Disease Index)

    Time frame: baseline, 4weeks, 8weeks, 12 weeks

  3. Change in TFBUT(Tear Film Break-up Time)

    Time frame: baseline, 4weeks, 8weeks, 12 weeks

  4. Change in conjunctival staining score

    Time frame: baseline, 4weeks, 8weeks, 12 weeks

  5. Change in corneal staining score

    Time frame: baseline, 4weeks, 8weeks

Sponsors and collaborators

Lead sponsor

Yungjin Pharm. Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, 12 Weeks, Phase II Clinical Study to Evaluate the Safety and Efficacy of Orally Administered KL7016 in Patients With Dry Eye Syndrome

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 20, 2014
Registry last updated
Dec 21, 2017

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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