Efficacy and Safety Study of FID 119515A

Alcon Research75 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Dry Eye

Interventions

FID 119515AOTHER

topical ocular drops

Blink® TearsOTHER

topical ocular drops

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Baseline, 60 minutes

Secondary Outcomes

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.

Time frame: 0 to 60 minutes

Data from ClinicalTrials.gov

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