Evaluation of Safety and Tolerability of Investigational Ocular Lubricants

October 10, 2023 updated by: Alcon Research
The purpose of this study is to evaluate investigational ocular lubricants for their safety and tolerability on subjects with mild to moderate dry eye disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects will be expected to attend a screening visit followed by 6 additional study visits. The expected duration of subject participation is approximately 3 weeks. This study will be conducted in Australia.

Study Type

Interventional

Enrollment (Actual)

47

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 Contact

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2000
        • George Street Eye Centre
    • Queensland
      • Teneriffe, Queensland, Australia, 4005
        • Ophthalmic Trials Australia
    • Victoria
      • Carlton, Victoria, Australia, 3053
        • University of Melbourne, Department of Optometry and Vision Science

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:

  • Sign an Informed Consent;
  • Have dry eye symptoms;
  • Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

  • Ocular abnormalities;
  • Active ocular infection or inflammation not associated with dry eye;
  • History of ocular or intraocular surgery;
  • Other protocol-defined 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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: FID123300/FID123301/FID122505
FID123300 ocular lubricant in Period 1, followed by FID12330 ocular lubricant in Period 2, followed by FID122505 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period.
Other: FID123300 ocular lubricant
Investigational ocular lubricant
Other: FID123301 ocular lubricant
Investigational ocular lubricant
Other: FID122505 ocular lubricant
Comparator ocular lubricant
Other: FID123301/FID122505/FID123300
FID123301 ocular lubricant in Period 1, followed by FID122505 ocular lubricant in Period 2, followed by FID123300 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period.
Other: FID123300 ocular lubricant
Investigational ocular lubricant
Other: FID123301 ocular lubricant
Investigational ocular lubricant
Other: FID122505 ocular lubricant
Comparator ocular lubricant
Other: FID122505/FID123300/FID123301
FID122505 ocular lubricant in Period 1, followed by FID123300 ocular lubricant in Period 2, followed by FID123301 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period.
Other: FID123300 ocular lubricant
Investigational ocular lubricant
Other: FID123301 ocular lubricant
Investigational ocular lubricant
Other: FID122505 ocular lubricant
Comparator ocular lubricant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best corrected visual acuity (BCVA) with manifest refraction, at distance
Time Frame: Day 1, each wear period. A wear period is 1 day.
BCVA will be collected for each eye individually and recorded in logarithm Minimum Angle of Resolution (logMAR)
Day 1, each wear period. A wear period is 1 day.

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)

July 24, 2023

Primary Completion (Actual)

September 27, 2023

Study Completion (Actual)

September 27, 2023

Study Registration Dates

First Submitted

May 9, 2023

First Submitted That Met QC Criteria

June 2, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Actual)

October 11, 2023

Last Update Submitted That Met QC Criteria

October 10, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEP918-E001

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

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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