Lipiflow Tratamento Isolado vs. Lipiflow + Tratamento Dextenza para Olho Seco
Dexametasona intracanalicular usada em conjunto com LipiFlow para o tratamento da disfunção da glândula meibomiana em pacientes com doença de olho seco evaporativo e evidência de inflamação 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.
Visão geral do estudo
Status
Condições
Descrição detalhada
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 de estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
-
-
Indiana
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Indianapolis, Indiana, Estados Unidos, 46040
- Eye Surgeons of Indiana
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Lipiflow Only Group
Patients with dry eye disease Lipiflow only |
To manage patients with dry eye disease secondary to MGD |
|
Experimental: 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
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change From Baseline in Meibomian Gland Scores (Expressibility and Quality)
Prazo: 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
Prazo: Assessed at Week 12
|
As measured by COMTOL Survey |
Assessed at Week 12
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The Rate of Positive MMP-9
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Damon Dierker, OD, FAAO, Eye Surgeons of Indiana
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças oculares
- Doenças do Aparelho Lacrimal
- Síndromes do Olho Seco
- Compostos de enxofre
- Produtos químicos orgânicos
- Hidrocarbonetos
- Hidrocarbonetos, cíclicos
- Hidrocarbonetos, aromáticos
- Derivados de benzeno
- Ácidos sulfônicos
- Ácidos de enxofre
- Benzenosulfonatos
- Arilsulfonatos
- Ácidos arilsulfônicos
- Dobesilato de Cálcio
Outros números de identificação do estudo
- The DIERKER Study
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