Phase 4
Completed N=30
Comparing Treatment of Dry Eye With Intracanalicular Dexamethasone, Restasis, and/or Lotemax
Source: ClinicalTrials.gov NCT04555694 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcomePrimary: Mean Ocular Surface Staining From Baseline — 0.8; 0.6; 0.5; 0.9 Score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Ocular Surface Staining From Baseline |
0.8; 0.6; 0.5; 0.9; 0.6; 1.1 | — |
| SECONDARY Mean Conjunctival Staining |
1.5; 0.5; 0.4; 0.9; 0.3; 0.5 | — |
| SECONDARY Mean Schirmer Tear Test 1 Score |
10.3; 14.9; 11.6; 12.9; 15.4; 10.1 | — |
| SECONDARY Tear Breakup Time (Seconds) |
5.4; 6.6; 5.7; 6.1; 8.0; 7.4 | — |
| SECONDARY Tear Osmolarity |
311.3; 295.5; 306.9; 307.7; 304.4; 307.9 | — |
| SECONDARY Meibomian Gland Scores |
7.1; 8.7; 9.2; 6.7; 7.6; 7.2 | — |
| SECONDARY DEQ-5 Score |
14.4; 14.1; 14.4; 11.0; 10.6; 12.2 | — |
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
Data sourced from ClinicalTrials.gov (NCT04555694). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.