Evaluation of Safety and Tolerability of Ocular Lubricants

NCT05573360 | Completed

• 1 other identifier: DEE253-E001
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (5)

• 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)

Study Arms (5)

Sequence 1

OTHER

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; Other: NGF4-B test formulation; Other: NGF6-B test formulation; Other: NGF6-E test formulation; Other: Systane eye drop

Sequence 2

OTHER

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; Other: NGF4-B test formulation; Other: NGF6-B test formulation; Other: NGF6-E test formulation; Other: Systane eye drop

Sequence 3

OTHER

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; Other: NGF4-B test formulation; Other: NGF6-B test formulation; Other: NGF6-E test formulation; Other: Systane eye drop

Sequence 4

OTHER

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; Other: NGF4-B test formulation; Other: NGF6-B test formulation; Other: NGF6-E test formulation; Other: Systane eye drop

Sequence 5

OTHER

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; Other: NGF4-B test formulation; Other: NGF6-B test formulation; Other: NGF6-E test formulation; Other: Systane eye drop

Interventions

NGF5-A test formulation OTHER

One drop of investigational product instilled on the eye

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5

NGF4-B test formulation OTHER

One drop of investigational product instilled on the eye

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5

NGF6-B test formulation OTHER

One drop of investigational product instilled on the eye

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5

NGF6-E test formulation OTHER

One drop of investigational product instilled on the eye

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5

Systane eye drop OTHER

One drop of commercial product instilled on the eye

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and sign an informed consent form.
• Willing and able to attend all study visits as required by the protocol.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (2)

Alcon Investigator 8169

Carlton, Victoria, 3053, Australia

Location

Alcon Investigator 8214

Waurn Ponds, Victoria, 3216, Australia

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Clinical Trial Lead, Dry Eye

  Alcon Research, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 10, 2022
• Study Start: December 16, 2022
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)