Efficacy and Safety Study of FID 119515A

Alcon

Status

Completed

Conditions

Dry Eye

Treatments

Other: FID 119515A

Other: Blink® Tears

Study type

Interventional

Funder types

Industry

Identifiers

NCT01833117

C-12-021

Details and patient eligibility

About

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.

Full description

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.

Enrollment

75 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.