Evaluation of Safety and Tolerability of Investigational Ocular Lubricants
1 other identifier
interventional
47
1 country
3
Brief Summary
The purpose of this study is to evaluate investigational ocular lubricants for their safety and tolerability on subjects with mild to moderate dry eye disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2023
Shorter than P25 for not_applicable
3 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
May 9, 2023
CompletedFirst Posted
Study publicly available on registry
June 5, 2023
CompletedStudy Start
First participant enrolled
July 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 27, 2023
CompletedOctober 11, 2023
October 1, 2023
2 months
May 9, 2023
October 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Best corrected visual acuity (BCVA) with manifest refraction, at distance
BCVA will be collected for each eye individually and recorded in logarithm Minimum Angle of Resolution (logMAR)
Day 1, each wear period. A wear period is 1 day.
Study Arms (3)
FID123300/FID123301/FID122505
OTHERFID123300 ocular lubricant in Period 1, followed by FID12330 ocular lubricant in Period 2, followed by FID122505 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period.
FID123301/FID122505/FID123300
OTHERFID123301 ocular lubricant in Period 1, followed by FID122505 ocular lubricant in Period 2, followed by FID123300 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period.
FID122505/FID123300/FID123301
OTHERFID122505 ocular lubricant in Period 1, followed by FID123300 ocular lubricant in Period 2, followed by FID123301 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period.
Interventions
Investigational ocular lubricant
Investigational ocular lubricant
Comparator ocular lubricant
Eligibility Criteria
You may qualify if:
- Sign an Informed Consent;
- Have dry eye symptoms;
You may not qualify if:
- Ocular abnormalities;
- Active ocular infection or inflammation not associated with dry eye;
- History of ocular or intraocular surgery;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (3)
George Street Eye Centre
Sydney, New South Wales, 2000, Australia
Ophthalmic Trials Australia
Teneriffe, Queensland, 4005, Australia
University of Melbourne, Department of Optometry and Vision Science
Carlton, Victoria, 3053, 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
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2023
First Posted
June 5, 2023
Study Start
July 24, 2023
Primary Completion
September 27, 2023
Study Completion
September 27, 2023
Last Updated
October 11, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share