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Efficacy and Safety Study of FID 119515A

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01833117
First Posted: April 16, 2013
Last Update Posted: July 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research
  Purpose
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.

Condition Intervention
Dry Eye Other: FID 119515A Other: Blink® Tears

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Observer-Masked, Efficacy and Safety Study of FID 119515A in Dry Eye

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Change From Baseline in Tear Break-up Time (TBUT) at 60 Minutes [ Time Frame: 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:
  • Area Under Curve (AUC) of TBUT From 0 to 60 Minutes [ Time Frame: 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.


Enrollment: 75
Study Start Date: May 2013
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01833117


Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Lisa Lindsey, PhD Alcon Research
  More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01833117     History of Changes
Other Study ID Numbers: C-12-021
First Submitted: April 12, 2013
First Posted: April 16, 2013
Results First Submitted: May 29, 2014
Results First Posted: June 30, 2014
Last Update Posted: July 14, 2014
Last Verified: June 2014

Keywords provided by Alcon Research:
Dry eye
Tear film
Tear break-up time
Ocular surface
Eye drops

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases