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Evaluation of Safety and Tolerability of Investigational Ocular Lubricants

Primary Purpose

Dry Eye Disease

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
FID123300 ocular lubricant
FID123301 ocular lubricant
FID122505 ocular lubricant
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • George Street Eye Centre
  • Ophthalmic Trials Australia
  • University of Melbourne, Department of Optometry and Vision Science

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

FID123300/FID123301/FID122505

FID123301/FID122505/FID123300

FID122505/FID123300/FID123301

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
May 9, 2023
Last Updated
October 10, 2023
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT05888519
Brief Title
Evaluation of Safety and Tolerability of Investigational Ocular Lubricants
Official Title
Evaluation of Safety and Tolerability of Investigational Ocular Lubricants
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 24, 2023 (Actual)
Primary Completion Date
September 27, 2023 (Actual)
Study Completion Date
September 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FID123300/FID123301/FID122505
Arm Type
Other
Arm Description
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.
Arm Title
FID123301/FID122505/FID123300
Arm Type
Other
Arm Description
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.
Arm Title
FID122505/FID123300/FID123301
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
FID123300 ocular lubricant
Intervention Description
Investigational ocular lubricant
Intervention Type
Other
Intervention Name(s)
FID123301 ocular lubricant
Intervention Description
Investigational ocular lubricant
Intervention Type
Other
Intervention Name(s)
FID122505 ocular lubricant
Intervention Description
Comparator ocular lubricant
Primary Outcome Measure Information:
Title
Best corrected visual acuity (BCVA) with manifest refraction, at distance
Description
BCVA will be collected for each eye individually and recorded in logarithm Minimum Angle of Resolution (logMAR)
Time Frame
Day 1, each wear period. A wear period is 1 day.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Lead, Dry Eye
Organizational Affiliation
Alcon Research, LLC
Official's Role
Study Director
Facility Information:
Facility Name
George Street Eye Centre
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
Ophthalmic Trials Australia
City
Teneriffe
State/Province
Queensland
ZIP/Postal Code
4005
Country
Australia
Facility Name
University of Melbourne, Department of Optometry and Vision Science
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of Safety and Tolerability of Investigational Ocular Lubricants

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