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

Phase 4

Completed

Conditions: Dry Eye

Interventions: Drug: Cyclosporine
Drug: Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert
Drug: Loteprednol Etabonate

Registration Number: NCT04555694

Lead Sponsor: Thomas Chester, OD

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Restasis	Cyclosporine	10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes
Restasis and Dextenza	Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert	10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids.
Restasis and Lotemax	Cyclosporine	10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes.
Restasis and Lotemax	Loteprednol Etabonate	10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes.
Restasis and Dextenza	Cyclosporine	10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids.

Primary Outcome Measures

Name	Time	Method
Mean Ocular Surface Staining From Baseline	Baseline to Week 4, Week 8 and Week 12	The primary outcome measure was the mean corneal surface staining (guided by use of fluorescein and lissamine green) at weeks 4, 8 and 12 from baseline based on the National Eye Institute grading scale. Corneal fluorescein staining was scored from 0 to 3 on the scale (none, better to heavy, worse) in five regions of the cornea and summed for a total score of 0-15.

Secondary Outcome Measures

Name	Time	Method
Tear Breakup Time (Seconds)	Baseline to Week 4, Week 8 and Week 12	The time it takes (in seconds) for the tear film to break after blinking at Week 4, 8 and 12 from Baseline
Meibomian Gland Scores	Baseline to Week 4, Week 8 and Week 12	Meibomian gland scoring on a scale of 1-4 (1 represents clear, liquid secretions and 4 is no secretions) in three regions (nasal, central, temporal) and summed for a single score between 3-12 at Week 4, 8 and 12 from baseline
Mean Schirmer Tear Test 1 Score	Baseline to Week 4, Week 8 and Week 12	Schirmer Tear Test 1 score, measuring tear production, as measured by a Schirmer's test strip with anesthetic (mm/5min on a strip 0-35mm. 0 mm is worse, \>15 indicates normal production) at week 4, 8 and 12 from Baseline.
Tear Osmolarity	Baseline to Week 4, Week 8 and Week 12	Tear osmolarity as measured by TearLab (275-307 is considered "homeostatic range") at Week 4, 8 and 12 from Baseline.
Mean Conjunctival Staining	Baseline to Week 4, Week 8 and Week 12	The mean conjunctival staining (guided by use of lissamine green) at weeks 4, 8 and 12 from baseline based on the National Eye Institute grading scale. Conjunctival staining was scored from 0 to 3 on the scale (none, better to heavy, worse) in six regions of the cornea and summed for a total score of 0-18.
DEQ-5 Score	Baseline to Week 4, Week 8 and Week 12	Dry Eye Questionnaire-5 (5 questions about dry eye symptoms rated from 0, or never to 5, or constantly) total score of 0-22 with higher scores representing worse symptoms at weeks 4, 8 and 12 from baseline