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OpenTrials
Completed

NCT Number: NCT04555694

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

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.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cleveland Eye Clinic

Brecksville, Ohio, 44141, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cyclosporine

Drug

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

Other names: Restasis

Loteprednol Etabonate

Drug

Used to treat inflammation of the eye

Other names: Lotemax

Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert

Drug

Used to treat inflammation of the eye

Other names: Dextenza

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Thomas Chester, OD

Other

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 21, 2020
Registry last updated
Oct 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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