Dry Eye Syndromes Clinical Trial
Official title:
A Phase II, Double-Masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle in Subjects With Dry Eye Disease
The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25% ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented clinical diagnosis of dry eye disease. The product will be studied over 28 days, with 1-2 drops instilled in each eye four times daily (QID).
This is a Phase II, multi-center, double-masked, randomized, vehicle-controlled, parallel-group study designed to evaluate the safety and efficacy of KPI-121 0.25% ophthalmic suspension versus vehicle in subjects with dry eye disease. Approximately 400 subjects will be screened and up to 150 subjects will be randomized at up to 12 centers located in the United States. Subjects will be randomized to 1 of 2 study arms in an approximate 1:1 ratio. The study arms are: 1) KPI-121 0.25% ophthalmic suspension administered 1-2 drops in each eye QID for up to 28 days or 2) vehicle administered as 1-2 drops in each eye QID for up to 28 days. This study will include up to 6 clinic visits over 6 weeks. At Visit 1 Screening (14 ± 1 days prior to Day 1), subjects who meet screening inclusion/exclusion criteria will begin a 2-week run-in period during which they will be treated with 1-2 drops of single-masked vehicle in each eye QID for 14 ± 1 days. At Visit 2, Randomization (Day 1), subjects who continue to meet inclusion/exclusion criteria will be eligible for randomization to 1 of the 2 arms of the study (i.e., KPI-121 0.25% ophthalmic suspension or vehicle). Following randomization, subjects will be instructed to return to the clinic to have a complete study evaluation at Study Visits 4 and 6 (Days 15 ± 1 day and 29 ± 1 day, respectively). Subjects will further be instructed to return to the clinic for diary collection and in-clinic symptom assessment only at Visits 3 and 5 (Days 8 ± 1 day and 22 ± 1 day, respectively). The last dose of investigational product and the final study visit will occur upon completion of 28 ± 1 days of exposure to investigational product. Subjects will be released from the study at the end of Visit 6 (Day 29 ± 1 day). ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04425551 -
Effect of Micropulse Laser on Dry Eye Disease Due to Meibomian Gland Dysfunction
|
N/A | |
| Not yet recruiting |
NCT06379685 -
Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface.
|
Phase 1 | |
| Recruiting |
NCT04701086 -
3 Month Study of Cationorm Pro Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis
|
N/A | |
| Active, not recruiting |
NCT03697876 -
Safety and Tolerability of the Ophthalmic Gel PRO-165 Versus Artelac® Nightime Gel
|
Phase 1 | |
| Terminated |
NCT02815293 -
Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye
|
Phase 3 | |
| Completed |
NCT02910713 -
Evaluation of Dry Eye Symptoms in CAE With Application of Intranasal Neurostimulation
|
N/A | |
| Completed |
NCT04104997 -
A Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of GLH8NDE After Single and Mutiple Ocular Administrations in Healthy Korean and Caucasian Volunteers
|
Phase 1 | |
| Recruiting |
NCT02595606 -
0.3% Sodium Hyaluronate in the Treatment of Dry Eye of Diabetic Patients
|
Phase 4 | |
| Completed |
NCT01711424 -
An Observational Study of OPTIVE PLUS® for the Treatment of Dry Eye Disease
|
N/A | |
| Completed |
NCT01015209 -
Safety and Tolerability of Chitosan-N-acetylcysteine Eye Drops in Healthy Young Volunteers
|
Phase 1 | |
| Completed |
NCT01202747 -
Evaluation of Screening Methods for Treatment of Meibomian Gland Dysfunction
|
Phase 2/Phase 3 | |
| Completed |
NCT00969280 -
Acupuncture for Dry Eye Syndrome
|
Phase 3 | |
| Completed |
NCT00756678 -
Efficacy and Acceptability of Two Lubricant Eye Drops
|
Phase 4 | |
| Completed |
NCT01496482 -
Comparison of Evaporimetry With the Established Methods of Tear Film Measurement
|
N/A | |
| Completed |
NCT00739713 -
Effects of Sea Buckthorn Oil on Dry Eye
|
N/A | |
| Completed |
NCT00349440 -
Efficacy of Cyclosporine for the Prevention and Treatment of Dry Eye Symptoms Following LASIK or Photorefractive Keratectomy
|
Phase 4 | |
| Completed |
NCT00370747 -
Efficacy and Safety Study for Ecabet Ophthalmic Solution for Treating Dry Eye Syndrome
|
Phase 2 | |
| Completed |
NCT05162261 -
to Evaluate the Effectiveness and Safety of the Tixel® , VS LipiFlow® in the Treatment of Meibomian Gland Dysfunction
|
N/A | |
| Completed |
NCT02871440 -
A Two Comparator, Controlled Phase 3 Study in Patients With and Without Evaporative Dry Eye
|
Phase 3 | |
| Completed |
NCT05042960 -
Computer Screen Properties Study
|
N/A |