Evaluation of the Safety and Tolerability of Ocular Lubricants

August 13, 2025 updated by: Alcon Research
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2052
        • School of Optometry and Vision
    • Queensland
      • Spring Hill, Queensland, Australia, 4000
        • Advanced Optometry
      • Teneriffe, Queensland, Australia, 4005
        • Ophthalmic Trials Australia
    • Victoria
      • Carlton, Victoria, Australia, 3053
        • The University of Melbourne, Department of Optometry and Vision Science
      • Waurn Ponds, Victoria, Australia, 3216
        • Deakin Collaborative Eye Care Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Willing and able to understand and sign an Ethics Committee-approved informed consent 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.

Key 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.
  • 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 the previous 1 month.
  • Has undergone any ocular surgery (including intraocular surgery) within the past 12 months 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Sequence 1
FID123359/ FID123360/ FID123361/FID121843: One drop in each eye, test formulation or ocular lubricant as randomized, at respective Investigational Product visit. A total of 4 drops per eye will be instilled.
Other: FID123359 test formulation
Investigational product
Other: FID123360 test formulation
Investigational product
Other: FID123361 test formulation
Investigational product
Other: FID121843 ocular lubricant
Commercially available, preservative-free eye drops
Other Names:
  • SYSTANE HYDRATION
Other: Sequence 2
FID123360/ FID123361/FID121843/ FID123359: One drop in each eye, test formulation or ocular lubricant as randomized, at respective Investigational Product visit. A total of 4 drops per eye will be instilled.
Other: FID123359 test formulation
Investigational product
Other: FID123360 test formulation
Investigational product
Other: FID123361 test formulation
Investigational product
Other: FID121843 ocular lubricant
Commercially available, preservative-free eye drops
Other Names:
  • SYSTANE HYDRATION
Other: Sequence 3
FID123361/FID121843/FID123359/ FID123360: One drop in each eye, test formulation or ocular lubricant as randomized, at respective Investigational Product visit. A total of 4 drops per eye will be instilled.
Other: FID123359 test formulation
Investigational product
Other: FID123360 test formulation
Investigational product
Other: FID123361 test formulation
Investigational product
Other: FID121843 ocular lubricant
Commercially available, preservative-free eye drops
Other Names:
  • SYSTANE HYDRATION
Other: Sequence 4
FID121843/FID123359/ FID123360/ FID123361: One drop in each eye, test formulation or ocular lubricant as randomized, at respective Investigational Product visit. A total of 4 drops per eye will be instilled.
Other: FID123359 test formulation
Investigational product
Other: FID123360 test formulation
Investigational product
Other: FID123361 test formulation
Investigational product
Other: FID121843 ocular lubricant
Commercially available, preservative-free eye drops
Other Names:
  • SYSTANE HYDRATION

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Treatment-Emergent Adverse Events (AEs)
Time Frame: Visit 2 (1 to 7 days after the Screening Visit) through Visit 6/Study Exit. Visit 6 will occur 7 to 27 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.
Visit 2 (1 to 7 days after the Screening Visit) through Visit 6/Study Exit. Visit 6 will occur 7 to 27 days after Visit 2 depending on observed visit windows.
Number of Subjects with Biomicroscopy Findings Outside of Normal Limit
Time Frame: Screening Visit through Visit 6/Study Exit. Visit 6 will occur 8 to 34 days after Screening Visit, based 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.
Screening Visit through Visit 6/Study Exit. Visit 6 will occur 8 to 34 days after Screening Visit, based on observed visit windows.
Best Corrected Visual Acuity (BCVA)
Time Frame: Screening through Visit 6/Study Exit. Visit 6 will occur 8 to 34 days after Screening Visit, based 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).
Screening through Visit 6/Study Exit. Visit 6 will occur 8 to 34 days after Screening Visit, based on observed visit windows.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

  • Study Director: Clinical Trial Lead, Dry Eye, Alcon Research, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2025

Primary Completion (Actual)

July 11, 2025

Study Completion (Actual)

July 11, 2025

Study Registration Dates

First Submitted

August 23, 2024

First Submitted That Met QC Criteria

August 23, 2024

First Posted (Actual)

August 26, 2024

Study Record Updates

Last Update Posted (Actual)

August 17, 2025

Last Update Submitted That Met QC Criteria

August 13, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEE253-E002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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