The purpose of this study is to evaluate the safety and tolerability of two new artificial tear formulations in subjects with moderate dry eye disease.
Each subject will receive 2 investigational products (one drop per eye of each investigational product) in a cross-over study design according to a randomization schedule. Individual duration of participation will be approximately 21 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
148
Investigational product
Investigational product
Investigational product
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States
School of Optometry and Vision
Sydney, New South Wales, Australia
Ophthalmic Trials Australia
Teneriffe, Queensland, Australia
The University of Melbourne, Department of Optometry and Vision Science
Carlton, Victoria, Australia
Number of Treatment-Emergent Adverse Events (AEs)
An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device (test product). The number of adverse events as observed or reported will be recorded.
Time frame: Visit 2 [1 to 7 days after Visit 1/Screening (Day 1)] through Exit Visit. Exit Visit will occur 3 to 13 days after Visit 2 depending on observed visit windows.]
Number of Subjects with Biomicroscopy Findings Outside of Normal Limit
The investigator will observe the corneal and other ocular structures under white light of the slit lamp. The number of subjects with biomicroscopy findings outside of normal limits will be recorded.
Time frame: Visit 1/Screening (Day 1) through Exit Visit. Exit Visit will occur 4 to 20 days after Visit 1 depending on observed visit windows.
Best Corrected Visual Acuity (BCVA)
BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts and recorded in logarithm Minimum angle of resolution (logMar).
Time frame: Visit 1/Screening (Day 1) through Exit Visit. Exit Visit will occur 4 to 20 days after Visit 1 depending on observed visit windows.
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Deakin Collaborative Eye Care Clinic, Deakin University
Waurn Ponds, Victoria, Australia