Post Menopausal Dry Eye Subjects Clinical Trial
| NCT number | NCT01105910 |
| Other study ID # | SMA-09-21 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | April 15, 2010 |
| Last updated | November 17, 2016 |
| Start date | February 2010 |
| Verified date | January 2012 |
| Source | Alcon Research |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
To evaluate the efficacy of Systane Ultra in post menopausal women with dry eye.
| Status | Completed |
| Enrollment | 70 |
| Est. completion date | |
| Est. primary completion date | December 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. Post-menopausal (menses ceased more than 12 months prior to the start of the study). 2. Diagnosed for dry eye Exclusion Criteria: 1. History of Sjögren's Syndrome or evidence of chronic dry eye syndrome. Confirmed autoimmune connective tissue diseases such as rheumatoid arthritis, fibromyalgia or scleroderma. 2. Active and severe blepharitis, rosacea and associated ocular sequelae. 3. Has any significant eyelid abnormality affecting lid function. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Alcon Research |
http://www.aaopt.org/efficacy-evaluation-systane-ultra-lubricant-eye-drops-postmenopausal-women-dry-eye
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Reduction in corneal staining | 30 days | No | |
| Secondary | Patient acceptability / comfort | 30 days | No |