Efficacy and Safety Study of FID 119515A

Dry Eye Clinical Trial

Official title:

A Randomized, Observer-Masked, Efficacy and Safety Study of FID 119515A in Dry Eye

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01833117
• Other study ID #: C-12-021
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: June 2013

Study information

• Verified date: April 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Other:
• FID 119515A
topical ocular drops
• Blink® Tears
topical ocular drops

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Area Under Curve (AUC) of TBUT From 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.	0 to 60 minutes

External Links

•   Results from the Novartis Clinical Trial Results Website