Evaluation of Safety and Tolerability of Ocular Lubricants

Dry Eye Clinical Trial

Official title:

Evaluation of Safety and Tolerability of Ocular Lubricants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05573360
• Other study ID #: DEE253-E001
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes

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)