Completed
A Randomized, Observer-Masked, Efficacy and Safety Study of FID 119515A in Dry Eye
What is being tested
FID 119515A
+ Blink® Tears
Other
Who is being recruted
Eye Diseases
+ Lacrimal Apparatus Diseases
+ Dry Eye Syndromes
Over 18 Years
+13 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: May 2013
Summary
Principal SponsorAlcon Research
Last updated: June 29, 2018
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2013
Actual date on which the first participant was enrolled.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.
Principal SponsorAlcon Research
Last updated: June 29, 2018
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
75 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Eye DiseasesLacrimal Apparatus DiseasesDry Eye Syndromes
Criteria
5 inclusion criteria required to participate
At least a 3 month documented history of dry eye in both eyes
Best corrected visual acuity (BCVA) of 55 or greater in each eye as measured by an ETDRS chart (letters read method)
Other protocol-defined inclusion criteria may apply
Sign Informed Consent
Show More Criteria
8 exclusion criteria prevent from participating
Any evidence of ocular infection or inflammation within 30 days prior to Screening
Any ocular surgery
Current presence of punctal plugs (permanent or temporary) or previous permanent punctal closure by cautery/diathermy
Ocular trauma requiring medical or pharmacological treatment within 1 year of Screening
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalFID 119515A, 1 drop instilled in the study eye, single dose
Group II
Active ComparatorBlink® Tears, 1 drop instilled in the study eye, single dose
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers