Trattamento Lipiflow da solo vs trattamento Lipiflow + Dextenza per la malattia dell'occhio secco
Desametasone intracanalicolare utilizzato in combinazione con LipiFlow per il trattamento della disfunzione della ghiandola di Meibomio in pazienti con malattia dell'occhio secco evaporativo e evidenza di infiammazione clinicamente significativa
To evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert in evaporative dry eye disease (DED) patients with meibomian gland disfunction (MGD) and underlying inflammation undergoing LipiFlow Thermal Pulsation.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
This prospective, open-label, single-center, non-randomized, investigator-sponsored clinical study seeks to investigate the benefit of managing patients with DED secondary to MGD with a sustained release intracanalicular dexamethasone (0.4 mg) insert in addition to LipiFlow Thermal Pulsation compared to LipiFlow Thermal Pulsation alone. In addition, this study will evaluate the ease of Dextenza insertion and the patient preference for therapy.
After screening a given patient for inclusion and exclusion criteria, and gaining informed consent, each eye will undergo LipiFlow Thermal Pulsation on the same day. The most symptomatic eye will be selected to receive DEXTENZA® insertion on the day of the procedure (study eye), while the other eye will be assigned to a receive a sham punctum dilation (control eye). If there is no obvious symptomatic difference, the right eye will receive the intracanalicular insert. Per patient, the study period will last for approximately 12 weeks after the LipiFlow procedure, consisting of one screening visit, one treatment v4isit and 3 post-procedure follow-up visits (week 1, week 4 and week 12). At week 1, week 4 and week 12, primary and secondary endpoints will be assessed alongside standard-of-care procedures. Adjusting for enrollment period, the study will last a total of approximately 4 months.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 4
Contatti e Sedi
Luoghi di studio
-
-
Indiana
-
Indianapolis, Indiana, Stati Uniti, 46040
- Eye Surgeons of Indiana
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
A patient's study eye must meet the following criteria to be eligible for inclusion in the study:
- 18 years of age or older
- Evaporative DED with MGD and clinically significant inflammation
- Willing and able to comply with clinic visits and study related procedures
- Willing and able to sign the informed consent form
Exclusion Criteria:
A patient who meets any of the following criteria will be excluded from the study:
- 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
- Patient being treated with either topical, oral, or intravenous steroids
- Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Lipiflow Only Group
Patients with dry eye disease Lipiflow only |
To manage patients with dry eye disease secondary to MGD |
|
Sperimentale: Lipiflow + Dextenza Group
Patients with dry eye disease Lipiflow + Dextenza |
to investigate the benefit of managing patients with DED secondary to MGD with a sustained release intracanalicular dexamethasone (0.4 mg) insert in addition to LipiFlow Thermal Pulsation
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change From Baseline in Meibomian Gland Scores (Expressibility and Quality)
Lasso di tempo: Assessed at Baseline, Week 1, Week 4 and Week 12
|
Meibomian gland expressibility was graded at the slit lamp using the methodology of the pivotal LipiFlow trial. Fifteen glands of the lower eyelid (5 temporal, 5 central, 5 nasal) were each graded on a 0-3 scale (0 = no secretion; 1 = inspissated/toothpaste-like secretion; 2 = cloudy liquid secretion; 3 = clear liquid secretion). Grades were summed to produce a composite Meibomian Gland Expressibility Score ranging from 0 to 45. Higher scores indicate better meibomian gland function. Values shown are the mean score at each study visit. |
Assessed at Baseline, Week 1, Week 4 and Week 12
|
|
Patient Preference
Lasso di tempo: Assessed at Week 12
|
As measured by COMTOL Survey |
Assessed at Week 12
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
The Rate of Positive MMP-9
Lasso di tempo: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
|
Meibomian gland inflammation was assessed using the InflammaDry point-of-care immunoassay, which detects elevated matrix metalloproteinase-9 (MMP-9) levels in tear fluid. Results are reported as positive or negative based on a predefined assay threshold. The outcome represents the proportion of eyes testing positive for MMP-9 at each study visit. |
Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
|
|
Mean Change in Ocular Surface Staining
Lasso di tempo: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
|
Corneal fluorescein staining was graded on a 0-3 scale (none to heavy) in 5 corneal regions (superior, inferior, nasal, temporal, central) and summed for a corneal score (range 0-15). Conjunctival lissamine green staining was graded on the same 0-3 scale in 6 conjunctival regions (3 nasal, 3 temporal) and summed for a conjunctival score (range 0-18). Corneal and conjunctival scores were summed to produce a total Ocular Surface Staining Score ranging from 0 to 33. Higher scores indicate greater ocular surface damage (worse outcome). Values shown are the mean score at each study visit. |
Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
|
|
Mean Change in Tear Break-up Time (TBUT)
Lasso di tempo: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
|
Tear break-up time (TBUT) was measured in seconds following fluorescein instillation as the interval between a complete blink and the first appearance of tear film disruption. Higher TBUT values indicate greater tear film stability. Values shown are the mean TBUT at each study visit. |
Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
|
|
Mean Change in Tear Osmolarity (mOsm/L)
Lasso di tempo: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
|
Tear osmolarity was measured using a point-of-care tear osmolarity system and reported in milliosmoles per liter (mOsm/L). Higher values indicate greater tear film hyperosmolarity and ocular surface stress. Values shown are the mean tear osmolarity at each study visit. |
Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
|
|
Mean Change in DEQ-5
Lasso di tempo: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
|
Dry eye symptoms were assessed using the Dry Eye Questionnaire-5 (DEQ-5), a validated patient-reported outcome instrument with scores ranging from 0 to 22. Higher DEQ-5 scores indicate greater severity of dry eye symptoms. The outcome represents the mean change in DEQ-5 score from baseline at each study visit. |
Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
|
|
Mean Change in Best-corrected Visual Acuity (BCVA)
Lasso di tempo: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
|
Best-corrected visual acuity (BCVA) was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart and recorded as the number of letters read correctly (range 0 to 100 letters). Higher letter scores indicate better visual acuity. Values shown are the mean BCVA letter score at each study visit. |
Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Damon Dierker, OD, FAAO, Eye Surgeons of Indiana
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie degli occhi
- Malattie dell'apparato lacrimale
- Sindromi dell'occhio secco
- Composti di zolfo
- Prodotti chimici organici
- Idrocarburi
- Idrocarburi, ciclici
- Idrocarburi, aromatici
- Derivati di benzene
- Acidi solfonici
- Acidi zolfo
- Benzenesolfonati
- Arilsulfonati
- Acidi arilsolfonici
- Dobesilato di calcio
Altri numeri di identificazione dello studio
- The DIERKER Study
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .