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OpenTrials
Completed

NCT Number: NCT05573360

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.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Investigator 8169, Carlton, Victoria, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NGF5-A test formulation

Other

One drop of investigational product instilled on the eye

NGF4-B test formulation

Other

One drop of investigational product instilled on the eye

NGF6-B test formulation

Other

One drop of investigational product instilled on the eye

NGF6-E test formulation

Other

One drop of investigational product instilled on the eye

Systane eye drop

Other

One drop of commercial product instilled on the eye

Primary outcomes

  1. Number of Treatment-Emergent Adverse Events (AEs)

    Time frame: 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.

  2. Number of Subjects with Biomicroscopy Findings Outside of Normal Limits

    Time frame: 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.

  3. Mean Total Ocular Surface Staining Score

    Time frame: Screening, up to Day 30 (Study Exit)

    Ocular surface staining will be assessed using a slit lamp and recorded on a 15-point scale.

  4. Mean Best Corrected Visual Acuity (BCVA)

    Time frame: 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).

  5. Number of Device Deficiencies

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 10, 2022
Registry last updated
Jul 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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