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 4, 2013
Last verified: June 2013
  Purpose

The purpose of this study is 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 topical ocular drops
Other: BLINK TEARS topical ocular drops

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 is instilled in the eye to assess tear break-up time. Tear break-up time will be assessed prior to test article instillation (baseline) and at 60 minutes post test article instillation.


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 is instilled in the eye to assess tear break-up time. Tear break-up time will be assessed prior to test article instillation (0 minutes) and at intervals up to 60 minutes post test article instillation.


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
1 drop in the study eye, single dose
Other: FID 119515A topical ocular drops
Active Comparator: BLINK TEARS
1 drop in the study eye, single dose
Other: BLINK TEARS topical ocular drops

Detailed Description:

Subjects who meet the enrollment criteria will be randomized in a 2:1 manner to receive treatment with FID 119515A or Blink Tears respectively for this one-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.
  • At least a 3 month documented history of dry eye in both eyes.
  • Tear break-up time and Ocular Surface Disease Index 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01833117

Locations
United States, Texas
Contact Alcon Call Center at 1-888-451-3937 for Trial Locations
Fort Worth, Texas, United States, 76134
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
Last Updated: June 4, 2013
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 April 15, 2014