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Development of new ophthalmic suspension prednisolone acetate 1. A Comparison of Three Different Formulations of Prednisolone Acetate 1% |
Development of new ophthalmic suspension prednisolone acetate 1 -
prednisolone acetate 1 % eye drops,suspension | Kaiser Permanente.
Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Results First Posted : April 21, Last Update Posted : June 3, Study Description. Detailed Description:. Overall Study Design: Structure: This is a randomized, double-masked prospective study.
Duration: Treatment duration: The duration of each subject's participation will be for up to 2 months after surgery. Controls: Examiner, staff, and subjects are masked. MedlinePlus related topics: Cataract Glaucoma. Drug Information available for: Prednisolone Prednisolone acetate Methylprednisolone acetate Methylprednisolone Prednisolone sodium phosphate Prednisolone phosphate Prednisolone sodium succinate Methylprednisolone sodium succinate.
FDA Resources. Arms and Interventions. Four drops daily decreasing to once daily over four weeks. Prednisolone Acetate four times daily decreasing to once daily over four weeks. Dosed four times daily decreasing to once daily over four weeks. Outcome Measures. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.
Inclusion Criteria: Be willing and able to provide written informed consent. Be able and willing to follow instructions on the use of the study medication and likely to complete the entire course of the study. Be male or female of any race at least 18 years of age. Have visually significant cataract or medically uncontrolled glaucoma for which they have elected to undergo surgery. Exclusion Criteria: Contraindication to use of corticosteroids. Ocular disease other than glaucoma or ocular hypertension that would interfere with study parameters such as: uveitis, ocular infection, or severe dry eye.
Subjects with mild chronic blepharitis, age-related macular degeneration and background diabetic retinopathy may be enrolled at the discretion of the investigator. Laser or any other intraocular surgery within the past three months. Have known allergy or sensitivity to the study medications or their components Have corneal abnormalities that would interfere with the ability to obtain an adequate laser flare measurement.
Be concurrently enrolled in an investigational drug or device study or participation within the last 30 days in any investigational drug or device study. Have a situation or condition that in the investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with participation in the study.
Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. More Information. Additional Information: Electronic Orange Book.
Cantor LB. Ophthalmic generic drug approval process: implications for efficacy and safety. J Glaucoma. Stoughton RB. Are generic formulations equivalent to trade name topical glucocorticoids?
Arch Dermatol. Olsen EA. A double-blind controlled comparison of generic and trade-name topical steroids using the vasoconstriction assay. Demonstration of therapeutic equivalence of generic and innovator beclomethasone in seasonal allergic rhinitis.
You may report side effects to Health Canada at Before using prednisolone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients such as sulfites found in some brands , which can cause allergic reactions or other problems.
Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of:. After you apply this drug, your vision may become temporarily unstable. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.
Before having surgery, tell your doctor or dentist about all the products you use including prescription drugs, nonprescription drugs, and herbal products. If you develop a new eye infection or injury, or require eye surgery, ask your doctor if you should continue to use your current bottle of prednisolone eye drops or start a new bottle. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is not known if the medication in this product passes into breast milk.
Consult your doctor before breast-feeding. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Do not start, stop, or change the dosage of any medicines without your doctor's approval. This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call Otherwise, call a poison control center right away.
US residents can call their local poison control center at Canada residents can call a provincial poison control center. This medication has been prescribed for your current condition only. Do not use it later for another eye condition unless told to do so by your doctor. A different medication may be necessary in that case.
Consult your doctor for more details. If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up. Store at room temperature away from light. Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist.
Do not freeze. Do not store in the bathroom. Keep the bottle upright and tightly closed when not in use. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional.
Always ask your health care professional for complete information about this product and your specific health needs. This copyrighted material has been downloaded from a licensed data provider. The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional.
You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment. Want to stay signed on? We are unable to switch you to this area of care. View more photos. Tell your doctor if your condition does not improve after 2 days or if it worsens. Tell your doctor right away if any of these serious side effects occur: vision problems eye pain This medication may mask the signs of an eye infection.
Tell your doctor right away if you have any serious side effects, including: headache dizziness A very serious allergic reaction to this drug is rare. In the US - Call your doctor for medical advice about side effects. Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye infections recent eye surgery cataracts glaucoma open-angle type severe nearsightedness myopia diabetes After you apply this drug, your vision may become temporarily unstable.
Do not share this medication with others. Information last revised February Copyright c First Databank, Inc. Drug Encyclopedia.
❾-50%}Development of new ophthalmic suspension prednisolone acetate 1
Avoid excessive exposure to sunlight or other manipulations of ultra-violet primo. These things may have an easy drying or irritant effect. Resources to be careful of: Keep stretch use to a retinoid and avoid oil based cosmetics which can clog the effects. Be domestic when using BENZAC gel because benzoyl bachelor can bleach or discolour clothing or towels.
Side effects If musical swelling, irritation, redness or peeling occurs rinse use.
Study record managers: refer to the Data Element Definitions if submitting registration or results information. This is a randomized, double-masked prospective study. The study medications will be masked and randomized by the outpatient pharmacy at Indiana University Hospital. Treatment duration: The duration of each subject's participation will be for up to 2 months after surgery.
One hundred and two subjects will be enrolled over a twelve-month time span. Examiner, staff, and subjects are masked. Parallel group comparison. Subjects may not be currently on any steroid or ophthalmic non-steroidal anti-inflammatory NSAID therapy for a minimum of 6 weeks prior to surgery. After 1 month of therapy subjects will stop or continue steroid treatment based on clinical findings.
No other subconjunctival steroid or ointment will be used intra-operatively or post-operatively. The eye drop will be instilled per labeling instructions. Drug: Pred Forte Four drops daily decreasing to once daily over four weeks.
Drug: Prednisolone Acetate Dosed four times daily decreasing to once daily over four weeks. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below.
For general information, Learn About Clinical Studies. We're building a better ClinicalTrials. Check it out and tell us what you think! Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U.
Federal Government. Read our disclaimer for details. Results First Posted : April 21, Last Update Posted : June 3, Study Description. Detailed Description:. Overall Study Design: Structure: This is a randomized, double-masked prospective study. Duration: Treatment duration: The duration of each subject's participation will be for up to 2 months after surgery. Controls: Examiner, staff, and subjects are masked. MedlinePlus related topics: Cataract Glaucoma. Drug Information available for: Prednisolone Prednisolone acetate Methylprednisolone acetate Methylprednisolone Prednisolone sodium phosphate Prednisolone phosphate Prednisolone sodium succinate Methylprednisolone sodium succinate.
FDA Resources. Arms and Interventions. Four drops daily decreasing to once daily over four weeks. Prednisolone Acetate four times daily decreasing to once daily over four weeks. Dosed four times daily decreasing to once daily over four weeks.
Outcome Measures. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Inclusion Criteria: Be willing and able to provide written informed consent. Be able and willing to follow instructions on the use of the study medication and likely to complete the entire course of the study. Be male or female of any race at least 18 years of age. Have visually significant cataract or medically uncontrolled glaucoma for which they have elected to undergo surgery.
Exclusion Criteria: Contraindication to use of corticosteroids. Ocular disease other than glaucoma or ocular hypertension that would interfere with study parameters such as: uveitis, ocular infection, or severe dry eye.
Subjects with mild chronic blepharitis, age-related macular degeneration and background diabetic retinopathy may be enrolled at the discretion of the investigator. Laser or any other intraocular surgery within the past three months.
Have known allergy or sensitivity to the study medications or their components Have corneal abnormalities that would interfere with the ability to obtain an adequate laser flare measurement. Be concurrently enrolled in an investigational drug or device study or participation within the last 30 days in any investigational drug or device study.
Have a situation or condition that in the investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with participation in the study.
Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. More Information. Additional Information: Electronic Orange Book. Cantor LB. Ophthalmic generic drug approval process: implications for efficacy and safety.
J Glaucoma. Stoughton RB. Are generic formulations equivalent to trade name topical glucocorticoids? Arch Dermatol. Olsen EA. A double-blind controlled comparison of generic and trade-name topical steroids using the vasoconstriction assay. Demonstration of therapeutic equivalence of generic and innovator beclomethasone in seasonal allergic rhinitis. SAR Study Group. Ann Allergy Asthma Immunol. Therapeutic equivalence study of two formulations innovator v. S Afr Med J. Patient compliance with use of topical ophthalmic corticosteroid suspensions.
Am J Ophthalmol. Correlations between laser flare measurements and anterior chamber protein concentrations. Invest Ophthalmol Vis Sci. Glaucoma Cataract. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Phase 4. Study Type :. Interventional Clinical Trial.
Actual Enrollment :. Study Start Date :. Actual Primary Completion Date :. Actual Study Completion Date :. Other Name: Econopred Plus. Other Name: Pred Forte.
June 27, Key Record Dates.
In this work, prednisolone (PR)-containing eye drops were formulated with antimicrobial, mucoadhesive biopolymer and PR–cyclodextrin inclusion. This medication may mask the signs of an eye infection. It may also put you at greater risk of developing an eye infection, especially with prolonged use. In this work, prednisolone (PR)-containing eye drops were formulated with antimicrobial, mucoadhesive biopolymer and PR–cyclodextrin inclusion. If you develop a new eye infection or injury, or require eye surgery, ask your doctor if you should continue to use your current bottle of prednisolone eye. Prednisolone (Pred Forte) images. white - Prednisolone Acetate 1. Actual Study Completion Date :. A double-blind controlled comparison of generic and trade-name topical steroids using the vasoconstriction assay. Are generic formulations equivalent to trade name topical glucocorticoids? Correlations between laser flare measurements and anterior chamber protein concentrations.The photos shown are samples only Not all photos of the drug may be displayed. Your medication may look different. If you have questions, ask your pharmacist. Generic name: Prednisolone - ophthalmic. Pronunciation pred-NIS-oh-loan. Brand name s Pred Forte , Pred Mild. This medication is used to treat certain eye conditions due to inflammation or injury. Prednisolone works by relieving symptoms such as swelling, redness, and itching.
It belongs to a class of drugs known as corticosteroids. Unless otherwise directed by your doctor, do not wear contact lenses while you are using this medicine. Sterilize contact lenses according to the manufacturer's directions, and check with your doctor before you begin using them again. If your doctor does approve the wearing of contact lenses during treatment with this medication, remove the lenses before using the eye drops.
The preservative in this product may be absorbed by contact lenses. Wait at least 15 minutes after each dose of the eye drop before wearing the lenses again. To apply eye drops, wash your hands first. If you are using a suspension form of this medication, shake the bottle well before using. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface. Tilt your head back, look upward, and pull down the lower eyelid to make a pouch.
Hold the dropper directly over your eye and place 1 drop into the pouch. Look downward and gently close your eyes for 1 to 2 minutes. Place one finger at the corner of your eye near the nose and apply gentle pressure.
This will prevent the medication from draining out. Try not to blink and do not rub your eye. Repeat these steps for your other eye if so directed and if your dose is for more than 1 drop. Apply as often as directed by your doctor. Do not rinse the dropper. Replace the dropper cap after each use. If you are using another kind of eye medication for example, other drops or ointments , wait at least 5 to 10 minutes before applying other medications.
Use eye drops before eye ointments to allow the drops to enter the eye. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time s each day. The dosage and length of treatment are based on your medical condition and response to treatment. Do not use this medication more often or for longer than prescribed because doing so may increase your risk of side effects.
Continue to use this medication for the full time prescribed. Do not stop using this medication without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.
Do not use this product if it becomes contaminated for example, drops turn a dark color. Use of contaminated eye medication can cause infection, serious damage to the eye, and loss of vision. Contact your doctor or pharmacist for more information. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects.
Many people using this medication do not have serious side effects. Use of this medication for prolonged periods or in high doses may cause serious eye problems such as high pressure inside the eyes and cataracts. Tell your doctor right away if any of these serious side effects occur:. This medication may mask the signs of an eye infection. It may also put you at greater risk of developing an eye infection, especially with prolonged use. Your doctor will need to adjust your treatment.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. Call your doctor for medical advice about side effects. In Canada - Call your doctor for medical advice about side effects.
You may report side effects to Health Canada at Before using prednisolone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients such as sulfites found in some brands , which can cause allergic reactions or other problems.
Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of:. After you apply this drug, your vision may become temporarily unstable.
Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely. Before having surgery, tell your doctor or dentist about all the products you use including prescription drugs, nonprescription drugs, and herbal products. If you develop a new eye infection or injury, or require eye surgery, ask your doctor if you should continue to use your current bottle of prednisolone eye drops or start a new bottle.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is not known if the medication in this product passes into breast milk. Consult your doctor before breast-feeding. Drug interactions may change how your medications work or increase your risk for serious side effects.
This document does not contain all possible drug interactions. Do not start, stop, or change the dosage of any medicines without your doctor's approval. This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call Otherwise, call a poison control center right away.
US residents can call their local poison control center at Canada residents can call a provincial poison control center. This medication has been prescribed for your current condition only.
Do not use it later for another eye condition unless told to do so by your doctor. A different medication may be necessary in that case. Consult your doctor for more details. If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up. Store at room temperature away from light.
Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Do not freeze. Do not store in the bathroom.
Keep the bottle upright and tightly closed when not in use. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. This information does not assure that this product is safe, effective, or appropriate for you.
This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs. This copyrighted material has been downloaded from a licensed data provider.
The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.
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