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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05573360
Other study ID # DEE253-E001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 16, 2022
Est. completion date May 31, 2023

Study information

Verified date July 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 the safety profile of test formulations for an artificial tear product versus a comparator product.


Description:

Subjects will be randomized to one of five different treatment sequences. Subjects will attend 6 scheduled visits with an expected individual duration of participation of 11 to 42 days. This study will be conducted in Australia.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date May 31, 2023
Est. primary completion date May 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key Inclusion Criteria: - Able to understand and sign an informed consent form. - Willing and able to attend all study visits as required by the protocol. - Other protocol-defined inclusion criteria may apply. Exclusion Criteria: - Any known active ocular disease. - Any systemic condition that, in the opinion of the investigator, may affect a study outcome variable. - Any ocular injury to either eye in the past 12 weeks prior to screening. - Other protocol-defined exclusion criteria may apply.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
NGF5-A test formulation
One drop of investigational product instilled on the eye
NGF4-B test formulation
One drop of investigational product instilled on the eye
NGF6-B test formulation
One drop of investigational product instilled on the eye
NGF6-E test formulation
One drop of investigational product instilled on the eye
Systane eye drop
One drop of commercial product instilled on the eye

Locations

Country Name City State
Australia Alcon Investigator 8169 Carlton Victoria
Australia Alcon Investigator 8214 Waurn Ponds Victoria

Sponsors (1)

Lead Sponsor Collaborator
Alcon Research

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Up to Day 30 (Study Exit)
Primary Number of Subjects with Biomicroscopy Findings Outside of Normal Limits The cornea, conjunctiva, and eyelid will be assessed using a slit lamp. The number of subjects with biomicroscopy findings outside of normal limits will be recorded. Screening, up to Day 30 (Study Exit)
Primary Mean Total Ocular Surface Staining Score Ocular surface staining will be assessed using a slit lamp and recorded on a 15-point scale. Screening, up to Day 30 (Study Exit)
Primary Mean Best Corrected Visual Acuity (BCVA) Visual Acuity will be assessed with correction in place using letter charts. BCVA will be measured in logarithm Minimum Angle of Resolution (logMAR). Screening, up to Day 30 (Study Exit)
Primary Number of Device Deficiencies A device deficiency is inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety, or performance. The number of device deficiencies as observed or reported will be recorded. Up to Day 30 (Study Exit)
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