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

Dry Eye Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04555694
• Other study ID #: TC-2020-DexRes
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2020
• Est. completion date: February 16, 2022

Study information

• Verified date: September 2023
• Source: Cleveland Eye Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 16, 2022
• Est. primary completion date: February 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Cyclosporine
Used to increase tear production in patients who have dry eye caused by inflammation
• Loteprednol Etabonate
Used to treat inflammation of the eye
• Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert
Used to treat inflammation of the eye

Locations

Country	Name	City	State
United States	Cleveland Eye Clinic	Brecksville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Chester, OD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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