Efficacy and Safety Study of FID 119515A

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dry Eye

Intervention / Treatment
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* Other: FID 119515A
* Other: Blink® Tears


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FID 119515A<br>FID 119515A, 1 drop instilled in the study eye, single dose | Other: FID 119515A<br>* topical ocular drops<br>|
| Active Comparator: Blink<br>Blink® Tears, 1 drop instilled in the study eye, single dose | Other: Blink® Tears<br>* topical ocular drops<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Tear Break-up Time (TBUT) at 60 Minutes | Fluorescein dye was instilled in the eye to assess tear break-up time. After instillation of the fluorescein, the subject was instructed to blink 3 times, then stare and not blink. The investigator measured the time from the last blink until the first black (dry) spot appeared in the precorneal tear film. Tear break-up time was assessed prior to test article instillation (baseline) and at 60 minutes. Three consecutive measurements were taken per eye at each time point, with the average of the 3 scores being the value analyzed. An increase in total score equates to improvement. One eye was chosen as the study eye and only data for the study eye were used. | Baseline, 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under Curve (AUC) of TBUT From 0 to 60 Minutes | Fluorescein dye was instilled in the eye to assess tear break-up time. After instillation of the fluorescein, the subject was instructed to blink 3 times, then stare and not blink. The investigator measured the time from the last blink until the first black (dry) spot appeared in the precorneal tear film. Tear break-up time was assessed prior to test article instillation (baseline) and at 5, 15, 30, and 60 minutes. Three consecutive measurements were taken per eye at each time point, with the average of the 3 scores being the value analyzed. An increase in total score equates to improvement. One eye was chosen as the study eye and only data for the study eye were used. | 0 to 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry eye, Tear film, Tear break-up time, Ocular surface, Eye drops