An interventional study of FID123359 test formulation and FID123360 test formulation in Dry Eye Disease, sponsored by Alcon Research. Terminated at 5 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-17.
Sponsored by Alcon Research · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate the safety and tolerability of three new artificial tear formulations in subjects with moderate dry eye disease.
This study will be conducted in 2 stages. In Stage 1, subjects will attend a total of 10 scheduled visits: one Screening visit, four Investigational Product visits, four 12-hour Follow Up visits (one for each Investigational Product visit), and an Exit visit. At each Investigational Product visit, subjects will receive one drop of the investigational product in each eye (2 drops total), as randomized. The first Investigational Product visit will occur 1 to 7 days after the Screening visit. A washout period of 2 to 7 days will separate each Investigational Product visit. Total individual duration of participation in Stage 1 will be 8 to 34 days. The planned enrollment for Stage 1 is 72 subjects.
At the conclusion of Stage 1, an interim analysis will be conducted to help determine potential adaptations to the study design for Stage 2.
This study will be conducted in Australia.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 73 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.
Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
FID123359/ FID123360/ FID123361/FID121843: One drop in each eye, test formulation or ocular lubricant as randomized, at respective Investigational Product visit. A total of 4 drops per eye will be instilled.
Other: FID123359 test formulation · Other: FID123360 test formulation · Other: FID123361 test formulation · Other: FID121843 ocular lubricant
FID123360/ FID123361/FID121843/ FID123359: One drop in each eye, test formulation or ocular lubricant as randomized, at respective Investigational Product visit. A total of 4 drops per eye will be instilled.
Other: FID123359 test formulation · Other: FID123360 test formulation · Other: FID123361 test formulation · Other: FID121843 ocular lubricant
FID123361/FID121843/FID123359/ FID123360: One drop in each eye, test formulation or ocular lubricant as randomized, at respective Investigational Product visit. A total of 4 drops per eye will be instilled.
Other: FID123359 test formulation · Other: FID123360 test formulation · Other: FID123361 test formulation · Other: FID121843 ocular lubricant
FID121843/FID123359/ FID123360/ FID123361: One drop in each eye, test formulation or ocular lubricant as randomized, at respective Investigational Product visit. A total of 4 drops per eye will be instilled.
Other: FID123359 test formulation · Other: FID123360 test formulation · Other: FID123361 test formulation · Other: FID121843 ocular lubricant
Investigational product
Investigational product
Investigational product
Commercially available, preservative-free eye drops
Also known as: SYSTANE HYDRATION
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 the Screening Visit) through Visit 6/Study Exit. Visit 6 will occur 7 to 27 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: Screening Visit through Visit 6/Study Exit. Visit 6 will occur 8 to 34 days after Screening Visit, based 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: Screening through Visit 6/Study Exit. Visit 6 will occur 8 to 34 days after Screening Visit, based on observed visit windows.
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Alcon Research