Safety Study of Tivanisiran to Treat Dry Eye

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

PHASE3

Total Enrollment

301 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-24

Study Completion Date

2023-10-11

Brief Summary

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This study will examine the safety of tivanisiran sodium eye drops versus vehicle when dosed once daily for 1 year in subjects with signs and symptoms of dry eye disease (DED).

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Detailed Description

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Conditions

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Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Tivanisiran sodium ophthalmic solution

Group Type EXPERIMENTAL

Tivanisiran sodium ophthalmic solution

Intervention Type DRUG

1 drop in the affected eye(s) once daily

Vehicle ophthalmic solution

Group Type PLACEBO_COMPARATOR

Vehicle ophthalmic solution

Intervention Type DRUG

1 drop in the affected eye(s) once daily

Interventions

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Tivanisiran sodium ophthalmic solution

1 drop in the affected eye(s) once daily

Intervention Type DRUG

Vehicle ophthalmic solution

1 drop in the affected eye(s) once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Be at least 18 years of age
* Have given their written consent to participate in the study
* Use of artificial tears (AT), autologous serum or specific dry eye medications during the last 6 months prior to the selection

Exclusion Criteria

* Pregnant or breast feeding females with a postitive pregnancy test
* Women of childbearing potential not willing to use a medically acceptable contraceptive method
* Currently participating or has participated in another clinical trial within the 2 months prior to inclusion
* Current, previous chronic or recurrent medical condition that, according to the investigator, might impact on the study
* Any concomitant treatment or prior ocular procedure or surgery in either eye or alteration of the dose of systemic medications that could interfere in the trial

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No