Efficacy and Safety Study of FID 119515A

NCT01833117 | Completed Results

• 1 other identifier: C-12-021
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dry Eye

Keywords

Dry eye; Tear film; Tear break-up time; Ocular surface; Eye drops

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Area Under Curve (AUC) of TBUT From 0 to 60 Minutes

  0 to 60 minutes

Study Arms (2)

FID 119515A

EXPERIMENTAL

FID 119515A, 1 drop instilled in the study eye, single dose

Other: FID 119515A

Blink

ACTIVE COMPARATOR

Blink® Tears, 1 drop instilled in the study eye, single dose

Other: Blink® Tears

Interventions

FID 119515A OTHER

topical ocular drops

FID 119515A

Blink® Tears OTHER

topical ocular drops

Blink

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Michela Montecchi-Palmer, Clinical Project Lead
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Lisa Lindsey, PhD

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2013
• First Posted: April 16, 2013
• Study Start: May 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 29, 2018
• Results First Posted: June 30, 2014

Record last verified: 2014-04