Recruitment

Recruitment Status
Completed
Estimated Enrollment
165

Inclusion Criteria

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

Exclusion Criteria

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

Summary

Conditions
Dry Eye Syndrome
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Care Provider, Investigator)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Inclusion Criteria

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

Exclusion Criteria

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

Locations

Seoul, Olympic-ro 43-gil, Songpa-gu, 138-736
Seoul, Neungdong-ro, Gwangjin-gu, 143-729
Gyeonggi-do, Gumi-ro 173 Beon-gil Bundang-gu, 463-707
Seoul, Banpo-daero, Seocho-gu, 137-701
Seoul, Eonju-ro, Gangnam-gu, 135-720
...
Seoul, Olympic-ro 43-gil, Songpa-gu, 138-736
Seoul, Neungdong-ro, Gwangjin-gu, 143-729
Gyeonggi-do, Gumi-ro 173 Beon-gil Bundang-gu, 463-707
Seoul, Banpo-daero, Seocho-gu, 137-701
Seoul, Eonju-ro, Gangnam-gu, 135-720
Seoul, Yonsei-ro, Seodaemun-gu, 120-752
Seoul, Irwon-ro, Gangnam-gu, 135-710
Seoul, Gurodong-ro, Guro-gu, 152-703
Gwangju, Jebong-ro, Dong-gu, 501-757

Tracking Information

NCT #
NCT02092207
Collaborators
Not Provided
Investigators
Not Provided