N/A N=62 Randomized Single-blind Treatment

Efficacy and Safety Study of FID 119515A

Dry Eye

Bottom Line

View on ClinicalTrials.gov: NCT01833117 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2014

Primary outcome: Primary: Mean Change From Baseline in Tear Break-up Time (TBUT) at 60 Minutes — 1.2; 1.2 seconds

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: FID 119515A (Other); Blink® Tears (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Alcon Research
Primary completion: Jun 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change From Baseline in Tear Break-up Time (TBUT) at 60 Minutes	1.2; 1.2	—
SECONDARY Area Under Curve (AUC) of TBUT From 0 to 60 Minutes	4.5; 4.5	—

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01833117). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.