Efficacy and Safety Study of FID 119515A

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Other: FID 119515A; Other: Blink® Tears

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Lisa Lindsey, PhD, Alcon Research

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: April 12, 2013
• First Submitted That Met QC Criteria: April 12, 2013
• First Posted (Estimate): April 16, 2013

Study Record Updates

• Last Update Posted (Actual): June 29, 2018
• Last Update Submitted That Met QC Criteria: May 31, 2018
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Dry eye; Tear film; Tear break-up time; Ocular surface; Eye drops
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: C-12-021