Blepharitis Clinical Trial
Official title:
A Multicenter Randomized, Double-Masked Study Comparing the Efficacy of Novabay iLid Cleanser Versus Vehicle on Ocular Skin Flora
This study is designed to evaluate the effect of Novabay iLid Cleanser, as compared to its
Vehicle, on the ocular skin flora.
In the pre-randomization phase, subjects will receive a single application of open-label
NovaBay iLid Cleanser.
In the randomization phase of Stages 1 and 2, subjects will self-treat with masked
Investigational Product twice daily for ten (10) days.
This is an adaptive design, randomized, double-masked, vehicle-controlled, multicenter,
parallel group study with two treatment arms: NovaBay iLid Cleanser ("Cleanser") and
Cleanser Vehicle ("Vehicle").
The study will be conducted in two Stages, each preceded by a pre-randomization phase.
Randomization of Cleanser:Vehicle will be 1:1 and 2:1 in Stages 1 and 2 respectively.
In the pre-randomization phase for Stages 1 and 2, subjects who meet all inclusion and no
exclusion criteria will be evaluated by clinical examination at a single visit prior to
having ocular skin specimens taken before and after treatment with open-label Cleanser.
In the randomization phase for both Stages 1 and 2, subjects who meet all inclusion and no
exclusion criteria will be randomized and evaluated at three visits:
- Visit 1: Screening, Day 1
- Visit 2: Day 11 (+2) End of Treatment (EOT)
- Visit 3: Day 18 (±2) Post Treatment Evaluation/Exit Subjects will have ocular skin
specimens taken at Visit 1, Day 1. The specimens will be collected before and 20
minutes after the first application of the study Investigational Product performed by
study personnel.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04475432 -
Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis
|
Phase 2/Phase 3 | |
| Completed |
NCT05062564 -
Efficacy of LipiFlow in Patients Affected by Meibomian Gland Dysfunction in Reducing Post-cataract Surgery Dry Eye
|
N/A | |
| Active, not recruiting |
NCT05629390 -
Trial to Evaluate the Efficacy and Safety of TP-03, LIBRA Study
|
Phase 3 | |
| Terminated |
NCT02938078 -
Ocular Comfort and Inflammation in Lid Hygiene Therapy
|
N/A | |
| Completed |
NCT01408082 -
Efficacy and Safety Study of a Steroid/Antibiotic Combination Eyedrop to Treat Non-Bacterial Blepharitis
|
Phase 3 | |
| Completed |
NCT01028027 -
Loteprednol and Tobramycin Versus Tobramycin and Dexamethasone, in the Treatment of Blepharokeratoconjunctivitis
|
Phase 3 | |
| Recruiting |
NCT04858113 -
Short-term Effects on Tear Film (Baby Shampoo vs Blephasol)
|
N/A | |
| Completed |
NCT00560703 -
Treatment of Patients With Blepharitis and Facial Rosacea
|
Phase 2 | |
| Completed |
NCT00894530 -
The Effects of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Blepharitis During a Four-Week Treatment Period (P08638)
|
Phase 2 | |
| Completed |
NCT01115192 -
Blephacura Versus Baby Shampoo to Treat Blepharitis
|
N/A | |
| Completed |
NCT02386774 -
Innovative Imaging of the Conjunctiva, Cornea, and Ocular Adnexa
|
N/A | |
| Completed |
NCT01808560 -
Treatment of Meibomian Gland Dysfunction Prior to Cataract Surgery
|
N/A | |
| Completed |
NCT01089608 -
Efficacy and Safety Assessment of Azyter® Eye Drops (T1225) in Patients With Blepharitis
|
Phase 2 | |
| Completed |
NCT00629590 -
Safety and Efficacy Pilot Study of AzaSite (Azithromycin) in Subjects With Blepharitis
|
Phase 4 | |
| Completed |
NCT00629941 -
Safety and Efficacy Study of AzaSite® in Subjects With Blepharitis
|
Phase 4 | |
| Completed |
NCT03926026 -
Study Evaluating the Safety and Tolerability of NCX 4251 for the Treatment of Acute Exacerbations of Blepharitis
|
Phase 2 | |
| Recruiting |
NCT04603222 -
Evaluation of SUMMIT BRUSH in Treatment of Blepharitis
|
N/A | |
| Completed |
NCT02218489 -
Safety and Efficacy of KPI-121 in Subjects With Inflammatory Meibomian Gland Disease
|
Phase 2 | |
| Completed |
NCT00796926 -
Trial to Compare the Efficacy of Systane Ultra and Refresh Drop in the Treatment of Dry Eye in Asian Eyes
|
Phase 3 | |
| Completed |
NCT00803452 -
Lipids of the Human Tear Film and Their Effect on Tear Stability
|
Phase 4 |