Study Stopped
Management decision
Evaluation of the Safety and Tolerability of Ocular Lubricants
1 other identifier
interventional
73
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2025
Shorter than P25 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2024
CompletedFirst Posted
Study publicly available on registry
August 26, 2024
CompletedStudy Start
First participant enrolled
April 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 11, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 11, 2025
CompletedAugust 17, 2025
August 1, 2025
3 months
August 23, 2024
August 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 (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.
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).
Screening through Visit 6/Study Exit. Visit 6 will occur 8 to 34 days after Screening Visit, based on observed visit windows.
Study Arms (4)
Sequence 1
OTHERFID123359/ 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.
Sequence 2
OTHERFID123360/ 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.
Sequence 3
OTHERFID123361/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.
Sequence 4
OTHERFID121843/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.
Interventions
Commercially available, preservative-free eye drops
Eligibility Criteria
You may qualify if:
- Willing and able to understand and sign an Ethics Committee-approved informed consent form.
- Willing and able to attend all study visits as required by the protocol.
- Exhibits symptoms of dry eye at the Screening Visit.
- Currently uses habitual artificial tears to alleviate dry eye symptoms.
- Willing and able to maintain similar environmental conditions throughout the study (for example, avoid extreme changes in humidity/temperature, avoid windy conditions) and refrain from swimming on Investigational Product visit days.
You may not qualify if:
- 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.
- Has had an ocular injury to either eye in the past 12 weeks prior to screening.
- Currently wears contact lenses or has a history of contact lens wear within the previous 1 month.
- Has undergone any ocular surgery (including intraocular surgery) within the past 12 months or has any ocular surgery planned during the study.
- Is pregnant, intends to become pregnant, or is breastfeeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (5)
School of Optometry and Vision
Sydney, New South Wales, 2052, Australia
Advanced Optometry
Spring Hill, Queensland, 4000, Australia
Ophthalmic Trials Australia
Teneriffe, Queensland, 4005, Australia
The University of Melbourne, Department of Optometry and Vision Science
Carlton, Victoria, 3053, Australia
Deakin Collaborative Eye Care Clinic
Waurn Ponds, Victoria, 3216, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trial Lead, Dry Eye
Alcon Research, LLC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2024
First Posted
August 26, 2024
Study Start
April 2, 2025
Primary Completion
July 11, 2025
Study Completion
July 11, 2025
Last Updated
August 17, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share