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

Study Overview
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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.

Official Title
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Intracanalicular Dexamethasone Used 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.

Conditions
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Dry Eye

Intervention / Treatment
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* Drug: Cyclosporine
* Drug: Loteprednol Etabonate
* Drug: Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 10 subjects will receive Restasis and Dextenza 10 subjects will receive Restasis and Lotemax 10 subjects will receive Restasis
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Restasis and Lotemax<br>10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes. | Drug: Cyclosporine<br>* Used to increase tear production in patients who have dry eye caused by inflammation<br>* Other names: Restasis;Drug: Loteprednol Etabonate<br>* Used to treat inflammation of the eye<br>* Other names: Lotemax;|
| Active Comparator: Restasis and Dextenza<br>10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids. | Drug: Cyclosporine<br>* Used to increase tear production in patients who have dry eye caused by inflammation<br>* Other names: Restasis;Drug: Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert<br>* Used to treat inflammation of the eye<br>* Other names: Dextenza;|
| Active Comparator: Restasis<br>10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes | Drug: Cyclosporine<br>* Used to increase tear production in patients who have dry eye caused by inflammation<br>* Other names: Restasis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Ocular Surface Staining From Baseline | 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. | Baseline to Week 4, Week 8 and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Conjunctival Staining | 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. | Baseline to Week 4, Week 8 and Week 12 | 
| Mean Schirmer Tear Test 1 Score | 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. | Baseline to Week 4, Week 8 and Week 12 | 
| Tear Breakup Time (Seconds) | The time it takes (in seconds) for the tear film to break after blinking at Week 4, 8 and 12 from Baseline | Baseline to Week 4, Week 8 and Week 12 | 
| Tear Osmolarity | Tear osmolarity as measured by TearLab (275-307 is considered homeostatic range) at Week 4, 8 and 12 from Baseline. | Baseline to Week 4, Week 8 and Week 12 | 
| Meibomian Gland Scores | 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 | Baseline to Week 4, Week 8 and Week 12 | 
| DEQ-5 Score | 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 | Baseline to Week 4, Week 8 and Week 12 |