Efficacy and Safety Study of FID 119515A

Not Applicable

Completed

• Conditions: Dry Eye
• Interventions: Other: Blink® Tears; Other: FID 119515A

• Registration Number: NCT01833117
• Lead Sponsor: Alcon Research

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2013-04-12
• Study First Submitted QC: 2013-04-12
• Study First Posted: 2013-04-16
• Study Start: 2013-05
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-04
• Results First Submitted: 2014-05-29
• Results First Submitted QC: 2014-05-29
• Results First Posted: 2014-06-30
• Last Update Submitted: 2018-05-31
• Last Update Posted: 2018-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blink	Blink® Tears	Blink® Tears, 1 drop instilled in the study eye, single dose
FID 119515A	FID 119515A	FID 119515A, 1 drop instilled in the study eye, single dose

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Tear Break-up Time (TBUT) at 60 Minutes	Baseline, 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.

Secondary Outcome Measures

Name	Time	Method
Area Under Curve (AUC) of TBUT From 0 to 60 Minutes	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.