Study of Safety and Performance of a Novel Ocular Lubricant in Subjects With Dry Eye Disease

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-04

Study Completion Date

2025-02-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate and demonstrate the efficacy and safety of an investigational ocular lubricant formulation in patients with mild to moderate dry eye disease (DED).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Safety and Tolerability of Investigational Ocular Lubricants

NCT05888519

Dry Eye Disease

COMPLETED NA

An Evaluation of the Nighttime Retention of Effect of an Investigational Lubricant Eye Drop (FID 115958D)

NCT01165164

Dry Eye

COMPLETED NA

Evaluation of the Safety and Tolerability of Ocular Lubricants

NCT06571656

Dry Eye Disease

TERMINATED NA

A Clinical Evaluation of an Investigational Lubricant Eye Gel (FID 115958D)

NCT01294956

Dry Eye

COMPLETED NA

Efficacy and Safety Study of FID 119515A

NCT01833117

Dry Eye

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study will consist of a Screening visit, a Baseline visit on Day 1, a remote Compliance Check on Day 14, and an Exit visit on Day 30. The expected study duration of participation for each subject is 37 days, with 30 ± 5 days of exposure to the investigational product.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dry Eye Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

FID123300

One drop of FID123300 ocular lubricant in each eye on Day 1 in the morning, followed by at least one drop in each eye 4 times a day on Days 2-30.

Group Type EXPERIMENTAL

FID123300 ocular lubricant

Intervention Type OTHER

Investigational ocular lubricant

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FID123300 ocular lubricant

Investigational ocular lubricant

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Willing and able to understand and sign an approved informed consent form.
* Exhibit symptoms of dry eye at the Screening visit.
* Best Corrected Visual Acuity equal to or better than 20/80 Snellen in each eye at the Screening visit.
* Willing to discontinue use of all artificial tear supplements and use only the study product as directed starting at Visit 2/Day 1.

Exclusion Criteria

* Pregnant, breastfeeding, or planning to become pregnant during the study.
* Ocular abnormalities that could adversely affect the safety or efficacy outcome.
* Uncontrolled active systemic diseases.
* Use of systemic medications known to cause dry eye.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No