Evaluation of Safety and Tolerability of Ocular Lubricants

NCT ID: NCT05573360

Last Updated: 2023-07-06

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

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-16

Study Completion Date

2023-05-31

Brief Summary

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The purpose of this study is to evaluate the safety profile of test formulations for an artificial tear product versus a comparator product.

Detailed Description

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Subjects will be randomized to one of five different treatment sequences. Subjects will attend 6 scheduled visits with an expected individual duration of participation of 11 to 42 days. This study will be conducted in Australia.

Conditions

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Dry Eye

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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Sequence 1

NGF5-A/NGF4-B/NGF6-B/NGF6-E/Systane, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation

Group Type OTHER

NGF5-A test formulation

Intervention Type OTHER

One drop of investigational product instilled on the eye

NGF4-B test formulation

Intervention Type OTHER

One drop of investigational product instilled on the eye

NGF6-B test formulation

Intervention Type OTHER

One drop of investigational product instilled on the eye

NGF6-E test formulation

Intervention Type OTHER

One drop of investigational product instilled on the eye

Systane eye drop

Intervention Type OTHER

One drop of commercial product instilled on the eye

Sequence 2

NGF4-B/NGF6-B/NGF6-E/Systane/NGF5-A, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation

Group Type OTHER

NGF5-A test formulation

Intervention Type OTHER

One drop of investigational product instilled on the eye

NGF4-B test formulation

Intervention Type OTHER

One drop of investigational product instilled on the eye

NGF6-B test formulation

Intervention Type OTHER

One drop of investigational product instilled on the eye

NGF6-E test formulation

Intervention Type OTHER

One drop of investigational product instilled on the eye

Systane eye drop

Intervention Type OTHER

One drop of commercial product instilled on the eye

Sequence 3

NGF6-B/NGF6-E/Systane/NGF5-A/NGF4-B, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation

Group Type OTHER

NGF5-A test formulation

Intervention Type OTHER

One drop of investigational product instilled on the eye

NGF4-B test formulation

Intervention Type OTHER

One drop of investigational product instilled on the eye

NGF6-B test formulation

Intervention Type OTHER

One drop of investigational product instilled on the eye

NGF6-E test formulation

Intervention Type OTHER

One drop of investigational product instilled on the eye

Systane eye drop

Intervention Type OTHER

One drop of commercial product instilled on the eye

Sequence 4

NGF6-E/Systane/NGF5-A/NGF4-B/NGF6-B, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation

Group Type OTHER

NGF5-A test formulation

Intervention Type OTHER

One drop of investigational product instilled on the eye

NGF4-B test formulation

Intervention Type OTHER

One drop of investigational product instilled on the eye

NGF6-B test formulation

Intervention Type OTHER

One drop of investigational product instilled on the eye

NGF6-E test formulation

Intervention Type OTHER

One drop of investigational product instilled on the eye

Systane eye drop

Intervention Type OTHER

One drop of commercial product instilled on the eye

Sequence 5

Systane/NGF5-A/NGF4-B/NGF6-B/NGF6-E, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation

Group Type OTHER

NGF5-A test formulation

Intervention Type OTHER

One drop of investigational product instilled on the eye

NGF4-B test formulation

Intervention Type OTHER

One drop of investigational product instilled on the eye

NGF6-B test formulation

Intervention Type OTHER

One drop of investigational product instilled on the eye

NGF6-E test formulation

Intervention Type OTHER

One drop of investigational product instilled on the eye

Systane eye drop

Intervention Type OTHER

One drop of commercial product instilled on the eye

Interventions

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NGF5-A test formulation

One drop of investigational product instilled on the eye

Intervention Type OTHER

NGF4-B test formulation

One drop of investigational product instilled on the eye

Intervention Type OTHER

NGF6-B test formulation

One drop of investigational product instilled on the eye

Intervention Type OTHER

NGF6-E test formulation

One drop of investigational product instilled on the eye

Intervention Type OTHER

Systane eye drop

One drop of commercial product instilled on the eye

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Able to understand and sign an informed consent form.
* Willing and able to attend all study visits as required by the protocol.

Exclusion Criteria

* Any known active ocular disease.
* Any systemic condition that, in the opinion of the investigator, may affect a study outcome variable.
* Any ocular injury to either eye in the past 12 weeks prior to screening.
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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Alcon Investigator 8169

Carlton, Victoria, Australia

Site Status

Alcon Investigator 8214

Waurn Ponds, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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DEE253-E001

Identifier Type: -

Identifier Source: org_study_id

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