Dvojité maskované srovnání oftalmického roztoku FID 123320 s vozidlem pro redukci zarudnutí oka
Dvojitě maskované srovnání oftalmického roztoku apraclonidin hydrochloridu s vehikulem pro snížení zarudnutí oka
The purpose of this study is to assess the safety and efficacy of Apraclonidine Hydrochloride Ophthalmic Solution 0.125% when compared to Vehicle in relieving redness of the eye due to minor eye irritations. This study will be conducted in the United States.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
The study will consist of six (6) scheduled visits: Screening and/or Baseline Visit (Day -7 to -1), Eligibility Confirmation/Randomization/1st Treatment Visit (Day 1), Week 2 Follow-Up Visit (Day 14), Week 4 Follow-Up Visit (Day 28), Week 8 Follow-Up/Treatment Discontinuation Visit (Day 56) and Exit Visit (Day 63). The expected individual duration of participation in the study is approximately 10 weeks with approximately 56 days of exposure to the investigational product.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 3
Kontakty a umístění
Studijní místa
-
-
California
-
Glendale, California, Spojené státy, 91204
- Global Research Management
-
-
North Carolina
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Garner, North Carolina, Spojené státy, 27529
- Oculus Research, Inc.
-
-
Pennsylvania
-
Cranberry Township, Pennsylvania, Spojené státy, 16066
- Scott & Christie and Associates, PC
-
-
Virginia
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Falls Church, Virginia, Spojené státy, 22046
- Emerson Clinical Research Institute, Inc.
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Lynchburg, Virginia, Spojené státy, 24502
- Piedmont Eye Center
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Key Inclusion Criteria:
- Capable of giving signed informed consent;
- Willing and able to follow all instructions and attend all study visits;
- Able to self-administer eye drops- in the opinion of the investigator;
- History of redness relief drop use within the last 6 months, or a desire to use over-the-counter (OTC) eye drops for redness relief;
- Females capable of becoming pregnant: Agree to urine pregnancy tests and the use of medically acceptable forms of birth control throughout the study;
- Ocular health within normal limits, including best-corrected visual acuity (BCVA) of 20/40 or better in each eye as measured using a Snellen chart;
- Ocular redness at baseline as specified in the protocol;
- Other protocol-specified inclusion criteria may apply.
Key Exclusion Criteria:
- Known contraindications or sensitivities to the use of any of the investigational drug(s) or their components, or any other medication required by the protocol;
- Ocular surgical interventions within 6 months prior to Visit 1 or during the study;
- Ocular conditions that, in the opinion of the investigator, could affect the subject's safety or study parameters (i.e., could affect ocular redness, intraocular pressure, or eyelid position);
- Disallowed medications or devices as specified in the protocol;
- Planned surgery (ocular or systemic) during the study period or within 30 days after the study period;
- Other protocol-defined exclusion criteria may apply.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Apraclonidine HCl 0.125%
1 drop instilled in each eye at Visit 2 (Day 1), followed by one drop instilled in each eye twice a day (approximately 12 hours apart) Day 2 up to Visit 5 (Day 56), followed by 1 drop instilled in each eye at Visit 5 (Day 56). |
Investigational ophthalmic solution applied topically to the eye with a dropper bottle
Ostatní jména:
|
|
Komparátor placeba: Vehicle
1 drop instilled in each eye at Visit 2 (Day 1), followed by one drop instilled in each eye twice a day (approximately 12 hours apart) Day 2 up to Visit 5 (Day 56), followed by 1 drop instilled in each eye at Visit 5 (Day 56). |
Vehicle (inactive ingredients) applied topically to the eye with a dropper bottle |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 15 Minutes Post-instillation on Day 1
Časové okno: Baseline (Day 1 pre-instillation); Minute 15 (Day 1 post-instillation)
|
Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). The change from baseline, calculated as post-instillation minus baseline scores, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint. |
Baseline (Day 1 pre-instillation); Minute 15 (Day 1 post-instillation)
|
|
Least Squares Mean Change From Baseline in Investigator-assessed Ocular Redness at 10 Hours (600 Minutes) Post-instillation on Day 1
Časové okno: Baseline (Day 1 pre-instillation); Hour 10 (600 minutes) (Day 1 post-instillation)
|
Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). The change from baseline, calculated as post-instillation minus baseline scores, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint. |
Baseline (Day 1 pre-instillation); Hour 10 (600 minutes) (Day 1 post-instillation)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Least Squares Mean Change From Baseline in Investigator-assessed Ocular Redness at 1 Minute Post-instillation on Day 1
Časové okno: Baseline (Day 1 pre-instillation); Minute 1 (Day 1 post-instillation)
|
Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). The change from baseline, calculated as post-instillation minus baseline scores, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). |
Baseline (Day 1 pre-instillation); Minute 1 (Day 1 post-instillation)
|
|
Least Squares Mean Change From Baseline in Investigator-assessed Ocular Redness at 8 Hours (480 Minutes) Post-instillation on Day 1
Časové okno: Baseline (Day 1 pre-instillation); Hour 8 (480 minutes) (Day 1 post-instillation)
|
Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). The change from baseline, calculated as post-instillation minus baseline scores, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). |
Baseline (Day 1 pre-instillation); Hour 8 (480 minutes) (Day 1 post-instillation)
|
|
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 12 Hours (720 Minutes) Post-instillation on Day 1
Časové okno: Baseline (Day 1 pre-instillation); Hour 12 (720 minutes) (Day 1 post-instillation)
|
Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). The change from baseline, calculated as post-instillation minus baseline scores, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). |
Baseline (Day 1 pre-instillation); Hour 12 (720 minutes) (Day 1 post-instillation)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Principal Clinical Trial Lead, Pharma, Alcon Research, LLC
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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