Evaluation of Safety and Tolerability of Ocular Lubricants

The purpose of this study is to evaluate the safety profile of test formulations for an artificial tear product versus a comparator product.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Other: NGF5-A test formulation; Other: NGF4-B test formulation; Other: NGF6-B test formulation; Other: NGF6-E test formulation; Other: Systane eye drop

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Carlton, Victoria, Australia, 3053
      • Alcon Investigator 8169
    • Waurn Ponds, Victoria, Australia, 3216
      • Alcon Investigator 8214

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Sequence 1; NGF5-A/NGF4-B/NGF6-B/NGF6-E/Systane, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation	Other: NGF5-A test formulation; One drop of investigational product instilled on the eye; Other: NGF4-B test formulation; One drop of investigational product instilled on the eye; Other: NGF6-B test formulation; One drop of investigational product instilled on the eye; Other: NGF6-E test formulation; One drop of investigational product instilled on the eye; Other: Systane eye drop; One drop of commercial product instilled on the eye
Other: Sequence 2; NGF4-B/NGF6-B/NGF6-E/Systane/NGF5-A, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation	Other: NGF5-A test formulation; One drop of investigational product instilled on the eye; Other: NGF4-B test formulation; One drop of investigational product instilled on the eye; Other: NGF6-B test formulation; One drop of investigational product instilled on the eye; Other: NGF6-E test formulation; One drop of investigational product instilled on the eye; Other: Systane eye drop; One drop of commercial product instilled on the eye
Other: Sequence 3; NGF6-B/NGF6-E/Systane/NGF5-A/NGF4-B, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation	Other: NGF5-A test formulation; One drop of investigational product instilled on the eye; Other: NGF4-B test formulation; One drop of investigational product instilled on the eye; Other: NGF6-B test formulation; One drop of investigational product instilled on the eye; Other: NGF6-E test formulation; One drop of investigational product instilled on the eye; Other: Systane eye drop; One drop of commercial product instilled on the eye
Other: Sequence 4; NGF6-E/Systane/NGF5-A/NGF4-B/NGF6-B, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation	Other: NGF5-A test formulation; One drop of investigational product instilled on the eye; Other: NGF4-B test formulation; One drop of investigational product instilled on the eye; Other: NGF6-B test formulation; One drop of investigational product instilled on the eye; Other: NGF6-E test formulation; One drop of investigational product instilled on the eye; Other: Systane eye drop; One drop of commercial product instilled on the eye
Other: Sequence 5; Systane/NGF5-A/NGF4-B/NGF6-B/NGF6-E, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation	Other: NGF5-A test formulation; One drop of investigational product instilled on the eye; Other: NGF4-B test formulation; One drop of investigational product instilled on the eye; Other: NGF6-B test formulation; One drop of investigational product instilled on the eye; Other: NGF6-E test formulation; One drop of investigational product instilled on the eye; Other: Systane eye drop; One drop of commercial product instilled on the eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Trial Lead, Dry Eye, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2022
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: October 4, 2022
• First Submitted That Met QC Criteria: October 6, 2022
• First Posted (Actual): October 10, 2022

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: DEE253-E001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No