Evaluation of the Safety and Tolerability of Ocular Lubricants

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

TERMINATED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-02

Study Completion Date

2025-07-11

Brief Summary

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

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Detailed Description

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This study will be conducted in 2 stages. In Stage 1, subjects will attend a total of 10 scheduled visits: one Screening visit, four Investigational Product visits, four 12-hour Follow Up visits (one for each Investigational Product visit), and an Exit visit. At each Investigational Product visit, subjects will receive one drop of the investigational product in each eye (2 drops total), as randomized. The first Investigational Product visit will occur 1 to 7 days after the Screening visit. A washout period of 2 to 7 days will separate each Investigational Product visit. Total individual duration of participation in Stage 1 will be 8 to 34 days. The planned enrollment for Stage 1 is 72 subjects.

At the conclusion of Stage 1, an interim analysis will be conducted to help determine potential adaptations to the study design for Stage 2.

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

DOUBLE

Participants Investigators

Study Groups

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Sequence 1

FID123359/ FID123360/ FID123361/FID121843: One drop in each eye, test formulation or ocular lubricant as randomized, at respective Investigational Product visit. A total of 4 drops per eye will be instilled.

Group Type OTHER

FID123359 test formulation

Intervention Type OTHER

Investigational product

FID123360 test formulation

Intervention Type OTHER

Investigational product

FID123361 test formulation

Intervention Type OTHER

Investigational product

FID121843 ocular lubricant

Intervention Type OTHER

Commercially available, preservative-free eye drops

Sequence 2

FID123360/ FID123361/FID121843/ FID123359: One drop in each eye, test formulation or ocular lubricant as randomized, at respective Investigational Product visit. A total of 4 drops per eye will be instilled.

Group Type OTHER

FID123359 test formulation

Intervention Type OTHER

Investigational product

FID123360 test formulation

Intervention Type OTHER

Investigational product

FID123361 test formulation

Intervention Type OTHER

Investigational product

FID121843 ocular lubricant

Intervention Type OTHER

Commercially available, preservative-free eye drops

Sequence 3

FID123361/FID121843/FID123359/ FID123360: One drop in each eye, test formulation or ocular lubricant as randomized, at respective Investigational Product visit. A total of 4 drops per eye will be instilled.

Group Type OTHER

FID123359 test formulation

Intervention Type OTHER

Investigational product

FID123360 test formulation

Intervention Type OTHER

Investigational product

FID123361 test formulation

Intervention Type OTHER

Investigational product

FID121843 ocular lubricant

Intervention Type OTHER

Commercially available, preservative-free eye drops

Sequence 4

FID121843/FID123359/ FID123360/ FID123361: One drop in each eye, test formulation or ocular lubricant as randomized, at respective Investigational Product visit. A total of 4 drops per eye will be instilled.

Group Type OTHER

FID123359 test formulation

Intervention Type OTHER

Investigational product

FID123360 test formulation

Intervention Type OTHER

Investigational product

FID123361 test formulation

Intervention Type OTHER

Investigational product

FID121843 ocular lubricant

Intervention Type OTHER

Commercially available, preservative-free eye drops

Interventions

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FID123359 test formulation

Investigational product

Intervention Type OTHER

FID123360 test formulation

Investigational product

Intervention Type OTHER

FID123361 test formulation

Investigational product

Intervention Type OTHER

FID121843 ocular lubricant

Commercially available, preservative-free eye drops

Intervention Type OTHER

Other Intervention Names

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SYSTANE HYDRATION

Eligibility Criteria

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Inclusion Criteria

* Willing and able to understand and sign an Ethics Committee-approved informed consent form.
* Willing and able to attend all study visits as required by the protocol.
* Exhibits symptoms of dry eye at the Screening Visit.
* Currently uses habitual artificial tears to alleviate dry eye symptoms.
* Willing and able to maintain similar environmental conditions throughout the study (for example, avoid extreme changes in humidity/temperature, avoid windy conditions) and refrain from swimming on Investigational Product visit days.

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.
* Has had an ocular injury to either eye in the past 12 weeks prior to screening.
* Currently wears contact lenses or has a history of contact lens wear within the previous 1 month.
* Has undergone any ocular surgery (including intraocular surgery) within the past 12 months or has any ocular surgery planned during the study.
* Is pregnant, intends to become pregnant, or is breastfeeding.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No