Dry Eye, Dry Eye Syndromes, Sjogren's Syndrome
Conditions
Brief summary
The primary objective of this study is to show that CEQUA (cyclosporine 0.09% ophthalmic solution) improves symptoms of dry eye disease in a population of patients with Sjogren's Syndrome diagnosis.
Detailed description
After being informed about the study and potential risks, all participants giving informed consent will have an eye exam and will be asked about their medical history to determine eligibility for the study. Eligible participants will continue to the second visit the same day or up to 10 days later. During the second visit participants will answer questionnaires about their eyes and have their vision, eyes, and tears examined. All participants will be given CEQUA to use over the duration of the study. The same procedures will be repeated every four weeks for 3 months total.
Interventions
DRUGCyclosporine 0.09% Ophthalmic Solution
one drop each eye twice daily
Sponsors
Sun Pharmaceutical Industries Limited
Center for Ophthalmic and Vision Research, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of Sjogren's Syndrome. * Self-reported complaints of ocular dryness for a period of at least 3 months * Best-corrected distance visual acuity of 20/25 or better in each eye.
Exclusion criteria
* Use of cyclosporine within the last 3 months. * Use of ocular steroid within the 3 months. * Previous history of treatment failure with cyclosporine. * Known hypersensitivity or contraindication to the study medication or any of its ingredients. * Use of any systemic or topical ocular medication that is known to cause or exacerbate dry eye. * Any active ocular infection. * Severe or serious ocular condition in either eye or any other unstable medical condition that may preclude study treatment or follow-up. * History or presence of chronic generalized systemic disease that might increase the risk to the subject or confound the results of the study. * Currently pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in total corneal staining | Baseline and week 12 | Expanded NEI corneal staining scale ranging from 0 to 15 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in total conjunctival staining | Baseline and week 12 | Expanded NEI conjunctival staining scale ranging from 0 to 20 |
| Mean change from baseline in the score of dry eye questionnaires | Baseline and week 12 | Dry eye questionnaire score ranging from 0 to 28 |
Countries
United States
Outcome results
None listed