Efficacy and Safety Study of FID 119515A

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01833117
First received: April 12, 2013
Last updated: June 27, 2014
Last verified: June 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01833117

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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01833117     History of Changes
Other Study ID Numbers: C-12-021
Study First Received: April 12, 2013
Results First Received: May 29, 2014
Last Updated: June 27, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 22, 2014