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

Thomas Chester, OD

Status and phase: Completed; Phase 4

Conditions: Dry Eye

Treatments: Drug: Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert; Drug: Loteprednol Etabonate; Drug: Cyclosporine

Study type: Interventional

Funder types: Other

Identifiers

NCT04555694

TC-2020-DexRes

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Restasis and Lotemax

Active Comparator group

Description:

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

Treatment:

Drug: Cyclosporine

Drug: Loteprednol Etabonate

Restasis and Dextenza

Active Comparator group

Description:

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

Treatment:

Drug: Cyclosporine

Drug: Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert

Restasis

Active Comparator group

Description:

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

Treatment:

Drug: Cyclosporine