An Evaluation of the Safety and Tolerability of Ocular Lubricants

NCT ID: NCT07238699

Last Updated: 2025-11-20

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-31

Study Completion Date

2026-08-31

Brief Summary

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The purpose of this study is to evaluate the safety and tolerability of two new artificial tear formulations in subjects with moderate dry eye disease.

Detailed Description

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Each subject will receive 2 investigational products (one drop per eye of each investigational product) in a cross-over study design according to a randomization schedule. Individual duration of participation will be approximately 21 days.

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

DOUBLE

Participants Investigators

Study Groups

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Sequence 1: FID123440, then FID123437

One drop of FID123440 test formulation in each eye in Period 1, followed by 1 drop of FID123437 test formulation in each eye in Period 2 as randomized. Each period is 1 day long with at least 2 calendar days separating the periods.

Group Type EXPERIMENTAL

FID123440 test formulation

Intervention Type OTHER

Investigational product

FID123437 test formulation

Intervention Type OTHER

Investigational product

Sequence 2: FID123437, then FID123440

One drop of FID123437 test formulation in each eye in Period 1, followed by 1 drop of FID123440 test formulation in each eye in Period 2 as randomized. Each period is 1 day long with at least 2 calendar days separating the periods.

Group Type EXPERIMENTAL

FID123437 test formulation

Intervention Type OTHER

Investigational product

FID123440 test formulation

Intervention Type OTHER

Investigational product

Interventions

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FID123440 test formulation

Investigational product

Intervention Type OTHER

FID123437 test formulation

Investigational product

Intervention Type OTHER

FID123440 test formulation

Investigational product

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subject must be willing and able to understand and sign an ethics committee approved informed consent form.
* Subject must be willing and able to attend all study visits as required by the protocol.
* Subject must exhibit symptoms of dry eye at the Screening Visit.
* Subject must currently use artificial tears.

Exclusion Criteria

* Has any known active ocular disease and/or infection.
* Has any known infection or inflammation that requires treatment or has a systemic condition that, in the opinion of the investigator, may affect a study outcome variable.
* Any ocular injury to either eye in the 12 weeks prior to screening.
* Current wearer of contact lenses or has a history of contact lens wear within the previous 1 month.
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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Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Site Status

School of Optometry and Vision

Sydney, New South Wales, Australia

Site Status

Ophthalmic Trials Australia

Teneriffe, Queensland, Australia

Site Status

The University of Melbourne, Department of Optometry and Vision Science

Carlton, Victoria, Australia

Site Status

Deakin Collaborative Eye Care Clinic, Deakin University

Waurn Ponds, Victoria, Australia

Site Status

Countries

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United States Australia

Central Contacts

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Alcon Call Center

Role: CONTACT

1-888-451-3937

Other Identifiers

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DEE253-E003

Identifier Type: -

Identifier Source: org_study_id

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