An Evaluation of the Safety and Tolerability of Ocular Lubricants
ConditionDry Eye Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlcon Research
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
FID123440 test formulation
Other interventionInvestigational product
FID123437 test formulation
Other interventionInvestigational product
FID123440 test formulation
Other interventionInvestigational product
Treatment groups
148 Participants
are divided into 2 treatment groupsGroup A: Sequence 1: FID123440, then FID123437Experimental treatment 2 interventions
Group B: Sequence 2: FID123437, then FID123440Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.]2
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.3
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov