Phase 2 Study to Evaluation the Safety and Efficacy of Orally Administered KL7016 in Patients With Dry Eye Syndrome
Last updated on April 2022Recruitment
- 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
- Persistent intraocular inflammation or infection
- Ocular herpes simplex virus infection
- Unstable use of methotrexate or Disease-modifying drugs
- ...
- Persistent intraocular inflammation or infection
- Ocular herpes simplex virus 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
- Intraocular surgery within 3months
- Concomitant use of contact lenses or use within 3months
- Stevens-Johnson Syndrome
- Corneal transplantation or neurotrophic keratitis
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
- Persistent intraocular inflammation or infection
- Ocular herpes simplex virus infection
- Unstable use of methotrexate or Disease-modifying drugs
- ...
- Persistent intraocular inflammation or infection
- Ocular herpes simplex virus 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
- Intraocular surgery within 3months
- Concomitant use of contact lenses or use within 3months
- Stevens-Johnson Syndrome
- Corneal transplantation or neurotrophic keratitis
Tracking Information
- NCT #
- NCT02092207
- Collaborators
- Not Provided
- Investigators
- Not Provided
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