Evaluation of Safety and Tolerability of Investigational Ocular Lubricants

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: Dry Eye Disease
• Intervention / Treatment: Other: FID123300 ocular lubricant; Other: FID123301 ocular lubricant; Other: FID122505 ocular lubricant

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

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

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

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	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

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

Study record dates

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: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• 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