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Prostaglandin Analog
Xalatan --> Apo-/Co-Latanoprost for Ocular Hypertension
Phase 4
Waitlist Available
Led By David B Yan, M.D., F.R.C.S. (C)
Research Sponsored by Dr. David Yan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Patients ≥ 18 years old, diagnosed with primary open angle glaucoma or ocular hypertension
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group
Approved for 5 Other Conditions
Summary
The purpose of the study is to provide evidence that the efficacy of Xalatan will be superior to Apo-latanoprost and Co-latanoprost in the reduction of intraocular pressure in patients with primary open angle glaucoma. The study will also aim to prove the tolerability of Xalatan in terms of ocular hyperemia will be equivalent to its generic counterparts.
Eligible Conditions
- Glaucoma
- Ocular Hypertension
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Intraocular Pressure
Secondary study objectives
Ocular Hyperemia
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Xalatan --> Apo-/Co-LatanoprostExperimental Treatment3 Interventions
Patients in this arm will be prescribed Xalatan for the first four week period of the study and one of the generics, Apo- or Co-Latanoprost, for the second four week period. Patients will take one drop of the assigned drops in the affected eye every evening at 2100 hrs (+- 1 hr)
Group II: Apo-/Co-Latanoprost --> XalatanExperimental Treatment3 Interventions
Patients in this arm will be prescribed one of the generics, Apo- or Co-Latanoprost, for the first four week period of the study and Xalatan for the second four week period. Patients will take one drop of the assigned drops in the affected eye every evening at 2100 hrs (+- 1 hr)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Latanoprost
FDA approved
Find a Location
Who is running the clinical trial?
AllerganIndustry Sponsor
781 Previous Clinical Trials
276,594 Total Patients Enrolled
85 Trials studying Ocular Hypertension
51,212 Patients Enrolled for Ocular Hypertension
Dr. David YanLead Sponsor
David B Yan, M.D., F.R.C.S. (C)Principal InvestigatorOphthalmic Diagnostic Services
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