Status:
COMPLETED
Efficacy and Safety Study of FID 119515A
Lead Sponsor:
Alcon Research
Conditions:
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Detailed 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01833117
Start Date
May 1 2013
End Date
June 1 2013
Last Update
June 29 2018
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