Comparing Treatment of Dry Eye With Intracanalicular Dexamethasone, Restasis, and/or Lotemax

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-02-16

Brief Summary

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This 6 month study seeks to compare the use of Intracanalicular Dexamethasone in conjunction with Restasis (cyclosporine ophthalmic emulsion) for the treatment of signs and symptoms of dry eye disease as compared to Restasis with Lotemax (loteprednol etabonate ophthalmic suspension 0.5%) and Restasis monotherapy.

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Detailed Description

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Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

10 subjects will receive Restasis and Dextenza 10 subjects will receive Restasis and Lotemax 10 subjects will receive Restasis

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Restasis and Lotemax

10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes.

Group Type ACTIVE_COMPARATOR

Cyclosporine

Intervention Type DRUG

Used to increase tear production in patients who have dry eye caused by inflammation

Loteprednol Etabonate

Intervention Type DRUG

Used to treat inflammation of the eye

Restasis and Dextenza

10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids.

Group Type ACTIVE_COMPARATOR

Cyclosporine

Intervention Type DRUG

Used to increase tear production in patients who have dry eye caused by inflammation

Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert

Intervention Type DRUG

Used to treat inflammation of the eye

Restasis

10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes

Group Type ACTIVE_COMPARATOR

Cyclosporine

Intervention Type DRUG

Used to increase tear production in patients who have dry eye caused by inflammation

Interventions

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Cyclosporine

Used to increase tear production in patients who have dry eye caused by inflammation

Intervention Type DRUG

Loteprednol Etabonate

Used to treat inflammation of the eye

Intervention Type DRUG

Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert

Used to treat inflammation of the eye

Intervention Type DRUG

Other Intervention Names

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Restasis Lotemax Dextenza

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* Signs and symptoms of Dry Eye Disease
* Consent to treat with topical immunomodulator
* Willing and able to comply with clinic visits and study related procedures
* Willing and able to sign the informed consent form

Exclusion Criteria

* Patients under the age of 18.
* Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
* Active infectious systemic disease
* Active infectious ocular or extraocular disease
* Altered nasolacrimal flow of either acquired, induced, or congenital origin
* Hypersensitivity to dexamethasone
* Patients who have been on topical immunomodulating agents in the previous 3 months to their baseline visit
* Patient being treated with either topical, oral, or intravenous immunosuppressive agents, immunomodulating agents, or steroid (including NSAIDS)
* Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes