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.
Overview
- Phase
- Phase 4
- Intervention
- Loteprednol Etabonate
- Conditions
- Dry Eye
- Sponsor
- Thomas Chester, OD
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Mean Ocular Surface Staining From Baseline
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Thomas Chester, OD
Principal Investigator
Cleveland Eye Clinic
Eligibility Criteria
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
- •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
Arms & Interventions
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.
Intervention: Loteprednol Etabonate
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.
Intervention: Cyclosporine
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.
Intervention: Cyclosporine
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.
Intervention: Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert
Restasis
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes
Intervention: Cyclosporine
Outcomes
Primary Outcomes
Mean Ocular Surface Staining From Baseline
Time Frame: 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 Outcomes
- Tear Breakup Time (Seconds)(Baseline to Week 4, Week 8 and Week 12)
- Meibomian Gland Scores(Baseline to Week 4, Week 8 and Week 12)
- Mean Schirmer Tear Test 1 Score(Baseline to Week 4, Week 8 and Week 12)
- Tear Osmolarity(Baseline to Week 4, Week 8 and Week 12)
- Mean Conjunctival Staining(Baseline to Week 4, Week 8 and Week 12)
- DEQ-5 Score(Baseline to Week 4, Week 8 and Week 12)