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NCT05888519 Clinical Trial

Evaluation of Safety and Tolerability of Investigational Ocular Lubricants

Dry Eye Disease Clinical Trial

Official title:
Evaluation of Safety and Tolerability of Investigational Ocular Lubricants

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05888519
Other study ID # DEP918-E001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 24, 2023
Est. completion date September 27, 2023

Study information
Verified date October 2023
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

Subjects will be expected to attend a screening visit followed by 6 additional study visits. The expected duration of subject participation is approximately 3 weeks. This study will be conducted in Australia.

Recruitment information / eligibility
Status Completed
Enrollment 47
Est. completion date September 27, 2023
Est. primary completion date September 27, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key Inclusion Criteria: - Sign an Informed Consent; - Have dry eye symptoms; - Other protocol-specified inclusion criteria may apply. Key Exclusion Criteria: - Ocular abnormalities; - Active ocular infection or inflammation not associated with dry eye; - History of ocular or intraocular surgery; - Other protocol-defined exclusion criteria may apply.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• FID123300 ocular lubricant
Investigational ocular lubricant
• FID123301 ocular lubricant
Investigational ocular lubricant
• FID122505 ocular lubricant
Comparator ocular lubricant

Locations
Country Name City State
Australia University of Melbourne, Department of Optometry and Vision Science Carlton Victoria
Australia George Street Eye Centre Sydney New South Wales
Australia Ophthalmic Trials Australia Teneriffe Queensland

Sponsors (1)
Lead Sponsor Collaborator
Alcon Research

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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.
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