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

Primary Purpose

Dry Eye

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Cyclosporine
Loteprednol Etabonate
Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert
Sponsored by
Thomas Chester, OD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 years of age or older
  • Signs and symptoms of DED
  • 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

Sites / Locations

  • Cleveland Eye Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Restasis and Lotemax

Restasis and Dextenza

Restasis

Arm Description

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

10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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
Tear Osmolarity
Tear osmolarity as measured by TearLab (275-307 is considered "homeostatic range") at Week 4, 8 and 12 from Baseline.
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
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

Full Information

First Posted
September 14, 2020
Last Updated
September 18, 2023
Sponsor
Thomas Chester, OD
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1. Study Identification

Unique Protocol Identification Number
NCT04555694
Brief Title
Comparing Treatment of Dry Eye With Intracanalicular Dexamethasone, Restasis, and/or Lotemax
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
February 16, 2022 (Actual)
Study Completion Date
February 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thomas Chester, OD

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Restasis and Lotemax
Arm Type
Active Comparator
Arm Description
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes.
Arm Title
Restasis and Dextenza
Arm Type
Active Comparator
Arm Description
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids.
Arm Title
Restasis
Arm Type
Active Comparator
Arm Description
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes
Intervention Type
Drug
Intervention Name(s)
Cyclosporine
Other Intervention Name(s)
Restasis
Intervention Description
Used to increase tear production in patients who have dry eye caused by inflammation
Intervention Type
Drug
Intervention Name(s)
Loteprednol Etabonate
Other Intervention Name(s)
Lotemax
Intervention Description
Used to treat inflammation of the eye
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert
Other Intervention Name(s)
Dextenza
Intervention Description
Used to treat inflammation of the eye
Primary Outcome Measure Information:
Title
Mean Ocular Surface Staining From Baseline
Description
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.
Time Frame
Baseline to Week 4, Week 8 and Week 12
Secondary Outcome Measure Information:
Title
Mean Conjunctival Staining
Description
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.
Time Frame
Baseline to Week 4, Week 8 and Week 12
Title
Mean Schirmer Tear Test 1 Score
Description
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.
Time Frame
Baseline to Week 4, Week 8 and Week 12
Title
Tear Breakup Time (Seconds)
Description
The time it takes (in seconds) for the tear film to break after blinking at Week 4, 8 and 12 from Baseline
Time Frame
Baseline to Week 4, Week 8 and Week 12
Title
Tear Osmolarity
Description
Tear osmolarity as measured by TearLab (275-307 is considered "homeostatic range") at Week 4, 8 and 12 from Baseline.
Time Frame
Baseline to Week 4, Week 8 and Week 12
Title
Meibomian Gland Scores
Description
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
Time Frame
Baseline to Week 4, Week 8 and Week 12
Title
DEQ-5 Score
Description
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
Time Frame
Baseline to Week 4, Week 8 and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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
Facility Information:
Facility Name
Cleveland Eye Clinic
City
Brecksville
State/Province
Ohio
ZIP/Postal Code
44141
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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