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

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

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

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

Tracking Information

NCT #
NCT02092207
Collaborators
Not Provided
Investigators
Not Provided