Efficacy and Safety Study of FID 119515A

A Randomized, Observer-Masked, Efficacy and Safety Study of FID 119515A in Dry Eye

The purpose of this study was 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 met the enrollment criteria were randomized in a 2:1 manner to receive treatment with FID 119515A or Blink® Tears respectively for this 1-day, single-dose study.

Inclusion Criteria:

• Sign Informed Consent.
• Best corrected visual acuity (BCVA) of 55 or greater in each eye as measured by an ETDRS chart (letters read method).
• At least a 3 month documented history of dry eye in both eyes.
• TBUT and Ocular Surface Disease Index (OSDI) 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.