RECRUITINGINTERVENTIONAL
An Evaluation of the Safety and Tolerability of Ocular Lubricants
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Subject must be willing and able to understand and sign an ethics committee approved willing to sign a consent form form.
- Subject must be willing and able to attend all study visits as required by the protocol.
- Subject must exhibit symptoms of dry eye at the Screening Visit.
- Subject must currently use artificial tears.
- Other protocol-defined inclusion criteria may apply.
Who Should NOT Join This Trial:
- Has any known active ocular disease and/or infection.
- Has any known infection or inflammation that requires treatment or has a systemic condition that, in the opinion of the investigator, may affect a study outcome variable.
- Any ocular injury to either eye in the 12 weeks prior to screening.
- Current wearer of contact lenses or has a history of contact lens wear within the previous 1 month.
- Other protocol-defined exclusion criteria may apply.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Subject must be willing and able to understand and sign an ethics committee approved informed consent form.
* Subject must be willing and able to attend all study visits as required by the protocol.
* Subject must exhibit symptoms of dry eye at the Screening Visit.
* Subject must currently use artificial tears.
* Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
* Has any known active ocular disease and/or infection.
* Has any known infection or inflammation that requires treatment or has a systemic condition that, in the opinion of the investigator, may affect a study outcome variable.
* Any ocular injury to either eye in the 12 weeks prior to screening.
* Current wearer of contact lenses or has a history of contact lens wear within the previous 1 month.
* Other protocol-defined exclusion criteria may apply.
Treatments Being Tested
OTHER
FID123440 test formulation
Investigational product
OTHER
FID123437 test formulation
Investigational product
OTHER
FID123440 test formulation
Investigational product
Locations (4)
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
Deakin Collaborative Eye Care Clinic, Deakin University
Waurn Ponds, Victoria, Australia