Dry Eye Disease
Conditions
Brief summary
To evaluate the efficacy and safety of INS365 Ophthalmic Solution when applied topically in patients with moderate to severe dry eye disease.
Interventions
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Inclusion criteria
* Best corrected visual acuity of at least +0.7 ETDRS * Six month history of dry eye disease * Mild severity in two out of five symptoms * Unanesthetized Schirmer score of less than or equal to 7mm * Corneal fluorescein staining greater than or equal to 4 out of 15 or lissamine green conjunctival staining of greater than or equal to 5 out of 18
Exclusion criteria
* Nasal stimulated Schirmer score of less than 3mm * Have ongoing ocular infection * Have congenitally absent meibomian or lacrimal glands * Have had punctal occlusion within a specified time prior to study * Wear contact lens and refuse to remove them * Have other excluded eye conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient-reported improvement of foreign body sensation | — |
| Schirmer scores | — |
| Corneal staining | — |
| Conjunctival staining | — |
| Tear break-up time | — |
| Change in artificial tear usage | — |
Secondary
| Measure | Time frame |
|---|---|
| IOP | — |
| Visual acuity | — |
| Investigator global severity assessment | — |
| Patient-reported dry eye symptoms other than foreign body sensation | — |
| Biomicroscopy | — |
| Ophthalmoscopy | — |
Outcome results
None listed