Evaluation of Safety and Tolerability of Ocular Lubricants

Not Applicable

Completed

• Conditions: Dry Eye
• Interventions: Other: NGF5-A test formulation; Other: NGF4-B test formulation; Other: NGF6-B test formulation; Other: NGF6-E test formulation; Other: Systane eye drop

• Registration Number: NCT05573360
• Lead Sponsor: Alcon Research

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-10-04
• Study First Submitted QC: 2022-10-06
• Study First Posted: 2022-10-10
• Study Start: 2022-12-16
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-03
• Last Update Posted: 2023-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 3	NGF5-A test formulation	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
Sequence 1	Systane eye drop	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
Sequence 2	Systane eye drop	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
Sequence 1	NGF5-A test formulation	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
Sequence 1	NGF6-B test formulation	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
Sequence 1	NGF6-E test formulation	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
Sequence 3	NGF6-B test formulation	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
Sequence 4	Systane eye drop	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
Sequence 1	NGF4-B test formulation	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
Sequence 3	NGF4-B test formulation	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
Sequence 4	NGF4-B test formulation	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
Sequence 4	NGF6-B test formulation	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
Sequence 5	NGF4-B test formulation	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
Sequence 4	NGF5-A test formulation	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
Sequence 5	NGF6-E test formulation	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
Sequence 5	Systane eye drop	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
Sequence 3	NGF6-E test formulation	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
Sequence 3	Systane eye drop	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
Sequence 2	NGF6-E test formulation	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
Sequence 4	NGF6-E test formulation	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
Sequence 5	NGF5-A test formulation	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
Sequence 5	NGF6-B test formulation	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
Sequence 2	NGF5-A test formulation	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
Sequence 2	NGF4-B test formulation	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
Sequence 2	NGF6-B test formulation	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

Primary Outcome Measures

Name	Time	Method
Number of Treatment-Emergent Adverse Events (AEs)	Up to Day 30 (Study Exit)	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.
Mean Best Corrected Visual Acuity (BCVA)	Screening, up to Day 30 (Study Exit)	Visual Acuity will be assessed with correction in place using letter charts. BCVA will be measured in logarithm Minimum Angle of Resolution (logMAR).
Number of Device Deficiencies	Up to Day 30 (Study Exit)	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.
Number of Subjects with Biomicroscopy Findings Outside of Normal Limits	Screening, up to Day 30 (Study Exit)	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.
Mean Total Ocular Surface Staining Score	Screening, up to Day 30 (Study Exit)	Ocular surface staining will be assessed using a slit lamp and recorded on a 15-point scale.

Trial Locations

Locations (2)

Alcon Investigator 8169; 🇦🇺 Carlton, Victoria, Australia

Alcon Investigator 8214; 🇦🇺 Waurn Ponds, Victoria, Australia