Evaluation of Safety and Tolerability of Investigational Ocular Lubricants

NCT ID: NCT05888519

Last Updated: 2023-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-24

Study Completion Date

2023-09-27

Brief Summary

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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

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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.

Conditions

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Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

FID123300 ocular lubricant

Intervention Type OTHER

Investigational ocular lubricant

FID123301 ocular lubricant

Intervention Type OTHER

Investigational ocular lubricant

FID122505 ocular lubricant

Intervention Type OTHER

Comparator ocular lubricant

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.

Group Type OTHER

FID123300 ocular lubricant

Intervention Type OTHER

Investigational ocular lubricant

FID123301 ocular lubricant

Intervention Type OTHER

Investigational ocular lubricant

FID122505 ocular lubricant

Intervention Type OTHER

Comparator ocular lubricant

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.

Group Type OTHER

FID123300 ocular lubricant

Intervention Type OTHER

Investigational ocular lubricant

FID123301 ocular lubricant

Intervention Type OTHER

Investigational ocular lubricant

FID122505 ocular lubricant

Intervention Type OTHER

Comparator ocular lubricant

Interventions

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FID123300 ocular lubricant

Investigational ocular lubricant

Intervention Type OTHER

FID123301 ocular lubricant

Investigational ocular lubricant

Intervention Type OTHER

FID122505 ocular lubricant

Comparator ocular lubricant

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Sign an Informed Consent;
* Have dry eye symptoms;

Exclusion Criteria

* Ocular abnormalities;
* Active ocular infection or inflammation not associated with dry eye;
* History of ocular or intraocular surgery;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Lead, Dry Eye

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

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George Street Eye Centre

Sydney, New South Wales, Australia

Site Status

Ophthalmic Trials Australia

Teneriffe, Queensland, Australia

Site Status

University of Melbourne, Department of Optometry and Vision Science

Carlton, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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DEP918-E001

Identifier Type: -

Identifier Source: org_study_id

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