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

NCT04555694 | Completed Phase 4 Results FDA Drug

• 1 other identifier: TC-2020-DexRes
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Mean Conjunctival Staining

  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 Breakup Time (Seconds)

  Baseline to Week 4, Week 8 and Week 12

• Tear Osmolarity

  Baseline to Week 4, Week 8 and Week 12

• Meibomian Gland Scores

  Baseline to Week 4, Week 8 and Week 12

Study Arms (3)

Restasis and Lotemax

ACTIVE COMPARATOR

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; Drug: Loteprednol Etabonate

Restasis and Dextenza

ACTIVE COMPARATOR

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; Drug: Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert

Restasis

ACTIVE COMPARATOR

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

Drug: Cyclosporine

Interventions

Cyclosporine DRUG

Used to increase tear production in patients who have dry eye caused by inflammation

Also known as: Restasis

Restasis; Restasis and Dextenza; Restasis and Lotemax

Loteprednol Etabonate DRUG

Used to treat inflammation of the eye

Also known as: Lotemax

Restasis and Lotemax

Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert DRUG

Used to treat inflammation of the eye

Also known as: Dextenza

Restasis and Dextenza

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Chester, OD: lead

Study Sites (1)

Cleveland Eye Clinic

Brecksville, Ohio, 44141, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Cyclosporine; Cyclosporins; Loteprednol Etabonate; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Dr. Thomas Chester, OD
• Organization: Cleveland Eye Clinic

tchester@midwestvision.com

440-526-1974

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 10 subjects will receive Restasis and Dextenza 10 subjects will receive Restasis and Lotemax 10 subjects will receive Restasis

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 21, 2020
• Study Start: October 1, 2020
• Primary Completion: February 16, 2022
• Study Completion: February 16, 2022
• Last Updated: October 11, 2023
• Results First Posted: October 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)