Efficacy and Safety Study of FID 119515A
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/27/2013 |
| Start Date: | May 2013 |
| End Date: | June 2013 |
| Contact: | Alcon Call Center |
| Email: | alcon.medinfo@alcon.com |
| Phone: | 1-888-451-3937 |
A Randomized, Observer-Masked, Efficacy and Safety Study of FID 119515A in Dry Eye
The purpose of this study is to compare the effect of FID 119515A to Blink® Tears on the
integrity of tear film in adults with a history of dry eye in both eyes.
Subjects who meet the enrollment criteria will be randomized in a 2:1 manner to receive
treatment with FID 119515A or Blink Tears respectively for this one-day, single-dose study.
Inclusion Criteria:
- Sign Informed Consent.
- At least a 3 month documented history of dry eye in both eyes.
- Tear break-up time and Ocular Surface Disease Index Questionnaire score as specified
in protocol.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Pregnant or breastfeeding.
- Any evidence of ocular infection or inflammation within 30 days prior to Screening.
- Any ocular surgery.
- Ocular trauma requiring medical or pharmacological treatment within 1 year of
Screening.
- Current presence of punctal plugs (permanent or temporary) or previous permanent
punctal closure by cautery/diathermy.
- Use of topical ocular prescription or non-prescription medications within 30 days of
Screening.
- Participation in any other clinical trial within 30 days prior to Screening.
- Other protocol-defined exclusion criteria may apply.
We found this trial at
1
site
Click here to add this to my saved trials
