Evaluation of the Safety and Tolerability of Ocular Lubricants

Last updated: April 14, 2025
Sponsor: Alcon Research
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dry Eye Disease

Treatment

FID123360 test formulation

FID123361 test formulation

FID123359 test formulation

Clinical Study ID

NCT06571656
DEE253-E002
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Willing and able to understand and sign an Ethics Committee-approved informedconsent form.

  • Willing and able to attend all study visits as required by the protocol.

  • Exhibits symptoms of dry eye at the Screening Visit.

  • Currently uses habitual artificial tears to alleviate dry eye symptoms.

  • Willing and able to maintain similar environmental conditions throughout the study (for example, avoid extreme changes in humidity/temperature, avoid windy conditions)and refrain from swimming on Investigational Product visit days.

  • Other protocol-specified inclusion criteria may apply.

Exclusion

Key Exclusion Criteria:

  • Has any known active ocular disease and/or infection.

  • Has any known infection or inflammation that requires treatment or has a systemiccondition that in the opinion of the investigator, may affect a study outcomevariable.

  • Has had an ocular injury to either eye in the past 12 weeks prior to screening.

  • Currently wears contact lenses or has a history of contact lens wear within theprevious 1 month.

  • Has undergone any ocular surgery (including intraocular surgery) within the past 12months or has any ocular surgery planned during the study.

  • Is pregnant, intends to become pregnant, or is breastfeeding.

  • Other protocol-specified exclusion criteria may apply.

Study Design

Total Participants: 72
Treatment Group(s): 4
Primary Treatment: FID123360 test formulation
Phase:
Study Start date:
April 02, 2025
Estimated Completion Date:
July 31, 2026

Study Description

This study will be conducted in 2 stages. In Stage 1, subjects will attend a total of 10 scheduled visits: one Screening visit, four Investigational Product visits, four 12-hour Follow Up visits (one for each Investigational Product visit), and an Exit visit. At each Investigational Product visit, subjects will receive one drop of the investigational product in each eye (2 drops total), as randomized. The first Investigational Product visit will occur 1 to 7 days after the Screening visit. A washout period of 2 to 7 days will separate each Investigational Product visit. Total individual duration of participation in Stage 1 will be 8 to 34 days. The planned enrollment for Stage 1 is 72 subjects.

At the conclusion of Stage 1, an interim analysis will be conducted to help determine potential adaptations to the study design for Stage 2.

This study will be conducted in Australia.

Connect with a study center

  • School of Optometry and Vision

    Sydney, New South Wales 2052
    Australia

    Active - Recruiting

  • Advanced Optometry

    Spring Hill, Queensland 4000
    Australia

    Active - Recruiting

  • Ophthalmic Trials Australia

    Teneriffe, Queensland 4005
    Australia

    Active - Recruiting

  • The University of Melbourne, Department of Optometry and Vision Science

    Carlton, Victoria 3053
    Australia

    Active - Recruiting

  • Deakin Collaborative Eye Care Clinic

    Waurn Ponds, Victoria 3216
    Australia

    Active - Recruiting

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