En dobbeltmasket sammenligning af FID 123320 oftalmisk opløsning til et køretøj til reduktion af øjenrødme
En dobbeltmasket sammenligning af apraclonidinhydrochlorid-ophthalmisk opløsning til vehikel til reduktion af øjenrødme
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
-
-
California
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Glendale, California, Forenede Stater, 91204
- Global Research Management
-
-
North Carolina
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Garner, North Carolina, Forenede Stater, 27529
- Oculus Research, Inc.
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Pennsylvania
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Cranberry Township, Pennsylvania, Forenede Stater, 16066
- Scott & Christie and Associates, PC
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Virginia
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Falls Church, Virginia, Forenede Stater, 22046
- Emerson Clinical Research Institute, Inc.
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Lynchburg, Virginia, Forenede Stater, 24502
- Piedmont Eye Center
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
Andre navne:
|
|
Placebo komparator: 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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 15 Minutes Post-instillation on Day 1
Tidsramme: 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
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Least Squares Mean Change From Baseline in Investigator-assessed Ocular Redness at 1 Minute Post-instillation on Day 1
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Principal Clinical Trial Lead, Pharma, Alcon Research, LLC
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- DEW422-C001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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