- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00501878
2.5% and 10% Phenylephrine for Mydriasis in Diabetic Patients With Darkly Pigmented Irides
March 7, 2012 updated by: Yosanan Yospaiboon, Khon Kaen University
To compare the clinical efficacy and systemic side effects between 2.5% and 10% phenylephrine for mydriasis in diabetic patient with darkly pigmented irides.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
One hundred patients with diabetes from Srinagarind Hospital Eye Clinic were enrolled and randomized into two groups by block randomization.
In group I (50 patients), 1% tropicamide combined with 2.5% phenylephrine were administered to dilate pupil whereas 1% tropicamide combined with 10% phenylephrine were used in Group II (50 patients).
Pupil diameter, blood pressure and heart rate were measured before and after eye drop instillations.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Khon Kaen, Thailand, 40002
- Srinagarind Hospital Eye Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- diabetic patients
Exclusion Criteria:
- history of intraocular surgery or laser treatment,
- any ocular diseases that might affect pupil size such as glaucoma,uveitis,Horner's syndrome, Adies' pupil,
- history of allergy to any drug used, and
- hypertension
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pupil diameters were measured.
Time Frame: before and after phenylephrine eye drop instillations
|
before and after phenylephrine eye drop instillations
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
blood pressure and heart rate were measured
Time Frame: before and after phenylephrine eye drop instillations
|
before and after phenylephrine eye drop instillations
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yosanan Yospaiboon, M.D., Khon Kaen University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Study Completion (ACTUAL)
July 1, 2007
Study Registration Dates
First Submitted
July 13, 2007
First Submitted That Met QC Criteria
July 13, 2007
First Posted (ESTIMATE)
July 16, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
March 9, 2012
Last Update Submitted That Met QC Criteria
March 7, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Eye Diseases
- Endocrine System Diseases
- Pupil Disorders
- Diabetes Mellitus
- Mydriasis
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Cardiotonic Agents
- Respiratory System Agents
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Nasal Decongestants
- Adrenergic alpha-1 Receptor Agonists
- Phenylephrine
- Oxymetazoline
Other Study ID Numbers
- I50138
- HE490619 (OTHER: Khon Kaen University Ethics Committee)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Mellitus
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
Guang NingRecruitingType 2 Diabetes Mellitus | Type1 Diabetes Mellitus | Monogenetic Diabetes | Pancreatogenic Diabetes | Drug-Induced Diabetes Mellitus | Other Forms of Diabetes MellitusChina
-
Meir Medical CenterCompletedDiabetes Mellitus Type 2 | Diabetes Mellitus, Non-insulin Dependant | Diabetes Mellitus, on Oral Hypoglycemic Treatment | Adult Type Diabetes MellitusIsrael
-
Medical College of WisconsinMedical University of South CarolinaCompletedDiabetes Mellitus | Type 2 Diabetes Mellitus | Adult-Onset Diabetes Mellitus | Non-Insulin-Dependent Diabetes Mellitus | Noninsulin Dependent Diabetes Mellitus, Type IIUnited States
-
Hanmi Pharmaceutical Company LimitedUnknownType2 Diabetes Mellitus | Type1 Diabetes MellitusUnited States
-
Peking Union Medical College HospitalUnknownType 2 Diabetes Mellitus | Type 1 Diabetes Mellitus | Gestational Diabetes Mellitus | Pancreatogenic Diabetes Mellitus | Pregestational Diabetes Mellitus | Diabetes Patients in Perioperative PeriodChina
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Medical College of WisconsinMedical University of South Carolina; National Institute of Diabetes and Digestive...Active, not recruitingDiabetes Mellitus, Type 2 | Diabetes Mellitus, Type II | Diabetes Mellitus, Adult-Onset | Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Mellitus, Noninsulin DependentUnited States
-
Medical College of WisconsinNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedDiabetes Mellitus, Type 2 | Diabetes Mellitus, Type II | Diabetes Mellitus, Adult-Onset | Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Mellitus, Noninsulin DependentUnited States
-
Medical University of South CarolinaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedDiabetes Mellitus, Type 2 | Diabetes Mellitus, Type II | Diabetes Mellitus, Adult-Onset | Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Mellitus, Noninsulin DependentUnited States
Clinical Trials on 2.5% or 10% phenylephrine
-
BayerMerck Sharp & Dohme LLC; Duke Clinical Research Institute; Canadian VIGOUR CentreCompletedChronic Heart Failure With Preserved Ejection FractionSpain, United States, Belgium, Singapore, Taiwan, Canada, Japan, Italy, Austria, Bulgaria, Germany, Greece, Israel, Poland, Portugal, Hungary, Russian Federation, Argentina, Colombia, Malaysia, South Africa
-
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co...Completed
-
AstraZenecaTerminatedType 2 DiabetesFrance, Korea, Republic of, South Africa, Spain, United Kingdom, Vietnam, Norway, Israel, Philippines, Australia
-
Eyenovia Inc.Completed
-
Eisai Inc.Completed
-
Carina Biotech LimitedRecruitingColorectal Cancer MetastaticAustralia
-
MedImmune LLCCompletedRelapsed/Refractory Aggressive B-cell LymphomasUnited States
-
Eisai Co., Ltd.Completed
-
Eisai Inc.BiogenActive, not recruitingAlzheimer's DiseaseUnited States, Canada, France, Germany, Italy, Japan, Korea, Republic of, Netherlands, Spain, Sweden, United Kingdom
-
Auro Vaccines LLCUnited States Department of Defense; AccelovanceCompletedEbola Virus DiseaseUnited States