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

September 18, 2023 updated by: Thomas Chester, OD

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Brecksville, Ohio, United States, 44141
        • Cleveland Eye Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: Loteprednol Etabonate
Used to treat inflammation of the eye
Other Names:
  • Lotemax
Drug: Cyclosporine
Used to increase tear production in patients who have dry eye caused by inflammation
Other Names:
  • Restasis
Active Comparator: 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.
Drug: Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert
Used to treat inflammation of the eye
Other Names:
  • Dextenza
Drug: Cyclosporine
Used to increase tear production in patients who have dry eye caused by inflammation
Other Names:
  • Restasis
Active Comparator: Restasis
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes
Drug: Cyclosporine
Used to increase tear production in patients who have dry eye caused by inflammation
Other Names:
  • Restasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to Week 4, Week 8 and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Conjunctival Staining
Time Frame: 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.
Baseline to Week 4, Week 8 and Week 12
Mean Schirmer Tear Test 1 Score
Time Frame: 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.
Baseline to Week 4, Week 8 and Week 12
Tear Breakup Time (Seconds)
Time Frame: 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
Baseline to Week 4, Week 8 and Week 12
Tear Osmolarity
Time Frame: 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.
Baseline to Week 4, Week 8 and Week 12
Meibomian Gland Scores
Time Frame: 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
Baseline to Week 4, Week 8 and Week 12
DEQ-5 Score
Time Frame: 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
Baseline to Week 4, Week 8 and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Chester, OD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

February 16, 2022

Study Completion (Actual)

February 16, 2022

Study Registration Dates

First Submitted

September 14, 2020

First Submitted That Met QC Criteria

September 14, 2020

First Posted (Actual)

September 21, 2020

Study Record Updates

Last Update Posted (Actual)

October 11, 2023

Last Update Submitted That Met QC Criteria

September 18, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TC-2020-DexRes

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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