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Completed

NCT Number: NCT07238699

An Evaluation of the Safety and Tolerability of Ocular Lubricants

The purpose of this study is to evaluate the safety and tolerability of two new artificial tear formulations in subjects with moderate dry eye disease.

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Key information

Conditions

Dry Eye Disease 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

School of Optometry and Vision, Sydney, New South Wales, Australia

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About this study

Each subject will receive 2 investigational products (one drop per eye of each investigational product) in a cross-over study design according to a randomization schedule. Individual duration of participation will be approximately 21 days.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject must be willing and able to understand and sign an ethics committee approved informed consent form.
  • Subject must be willing and able to attend all study visits as required by the protocol.
  • Subject must exhibit symptoms of dry eye at the Screening Visit.
  • Subject must currently use artificial tears.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Has any known active ocular disease and/or infection.
  • Has any known infection or inflammation that requires treatment or has a systemic condition that, in the opinion of the investigator, may affect a study outcome variable.
  • Any ocular injury to either eye in the 12 weeks prior to screening.
  • Current wearer of contact lenses or has a history of contact lens wear within the previous 1 month.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

FID123440 test formulation

Other

Investigational product

FID123437 test formulation

Other

Investigational product

Primary outcomes

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

    Time frame: Visit 2 [1 to 7 days after Visit 1/Screening (Day 1)] through Exit Visit. Exit Visit will occur 3 to 13 days after Visit 2 depending on observed visit windows.]

    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 Limit

    Time frame: Visit 1/Screening (Day 1) through Exit Visit. Exit Visit will occur 4 to 20 days after Visit 1 depending on observed visit windows.

    The investigator will observe the corneal and other ocular structures under white light of the slit lamp. The number of subjects with biomicroscopy findings outside of normal limits will be recorded.

  3. Best Corrected Visual Acuity (BCVA)

    Time frame: Visit 1/Screening (Day 1) through Exit Visit. Exit Visit will occur 4 to 20 days after Visit 1 depending on observed visit windows.

    BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts and recorded in logarithm Minimum angle of resolution (logMar).

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 20, 2025
Registry last updated
Jul 28, 2026

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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