Recruitment

Recruitment Status
Completed
Estimated Enrollment
165

Inclusion Criterias

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
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
Corneal staining score of ≥5 in either eye by the National Eye Institute/Industry Workshop guidelines

Exclusion Criterias

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

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 Criterias

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
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
Corneal staining score of ≥5 in either eye by the National Eye Institute/Industry Workshop guidelines

Exclusion Criterias

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

Locations

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

Tracking Information

NCT #
NCT02092207
Collaborators
Not Provided
Investigators
Not Provided