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Evaluation of the Safety and Tolerability of Ocular Lubricants
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.
Study details:
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. Subjects will receive one drop of the investigational product in each eye (2 drops total), as randomized, at each Investigational Product visit. The first Investigational Product visit will occur 2 to 45 days after the Screening visit.
A washout period of 2 to 7 days will separate each Investigational Product visit. Total duration of study participation for each subject will be approximately 2. 5 months.
This study will be conducted in Australia.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2025-01-01
Primary completion: 2025-08-01
Study completion finish: 2025-08-01
Study type
TREATMENT
Phase
NA
Trial ID
NCT06571656
Intervention or treatment
OTHER: FID123359 test formulation
OTHER: FID123360 test formulation
OTHER: FID123361 test formulation
OTHER: FID121843 ocular lubricant
Conditions
- • Dry Eye Disease
Find a site
Closest Location:
School of Optometry and Vision
Research sites nearby
Select from list below to view details:
School of Optometry and Vision
Sydney, New South Wales, Australia
The University of Melbourne, Department of Optometry and Vision Science
Carlton, Victoria, Australia
Deakin Collaborative Eye Care Clinic
Waurn Ponds, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
OTHER: Sequence 1
| OTHER: FID123359 test formulation
|
OTHER: Sequence 2
| OTHER: FID123359 test formulation
|
OTHER: Sequence 3
| OTHER: FID123359 test formulation
|
OTHER: Sequence 4
| OTHER: FID123359 test formulation
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| 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. | Visit 2 (2 to 45 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. | Screening Visit through Visit 6/Study Exit. Visit 6 will occur 9 to 77 days after Screening Visit, based on observed visit windows. |
| Best Corrected Visual Acuity (BCVA) with Manifest Refraction (MR) | BCVA with MR will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts and recorded in logarithm Minimum angle of resolution (logMar). | Screening through Visit 6/Study Exit. Visit 6 will occur 9 to 77 days after Screening Visit, based on observed visit windows. |
Secondary outcome
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