Recruitment

Recruitment Status
Completed
Estimated Enrollment
165

Inclusion Criteria

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 Criteria

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

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 Criteria

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

Tracking Information

NCT #
NCT02092207
Collaborators
Not Provided
Investigators
Not Provided