GlaucomaPhase 4NCT00345046
A Comparison of Three Different Formulations of Prednisolone Acetate 1%
A Phase 4 study testing Pred Forte, EconoPred Plus and Prednisolone Acetate in people with Glaucoma and Cataract, run by Indiana University at 1 site in United States.
Trial summary
Generic prednisolone acetate 1% is less effective than Pred Forte 1% or Econopred Plus 1%. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Pred Forte, EconoPred Plus and Prednisolone Acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Sep 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Require use of ocular NSAID or systemic steroids.
- 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.
Show all 9Show fewer
- Be concurrently enrolled in an investigational drug or device study or participation within the last 30 days in any investigational drug or device study.
- Be pregnant, nursing, planning a pregnancy, or be of childbearing potential and not using a reliable form of contraception (a woman is considered of childbearing potential unless she is postmenopausal, has had a uterus and/or both ovaries removed, or has had a bilateral tubal ligation).
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Three Different Formulations of Topical Prednisolone Acetate 1% for Control of Post Glaucoma and/or Cataract Surgery Inflammation.
Generic prednisolone acetate 1% is less effective than Pred Forte 1% or Econopred Plus 1%.
Read the detailed description
Overall Study Design:
Structure:
This is a randomized, double-masked prospective study. The study medications will be masked and randomized by the outpatient pharmacy at Indiana University Hospital.
Duration:
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.
Controls:
Examiner, staff, and subjects are masked. Parallel group comparison.
Dosage/Dose Regimen/Instructions:
Subjects scheduled for glaucoma and/or cataract surgery will be recruited. 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. Subjects will be randomized to receive a dose of Pred Forte 1% (Allergan), Econopred Plus 1% (Alcon) or prednisolone acetate 1% (Falcon) four times a day starting immediately after finishing the surgery for two weeks, then twice a day for two more weeks. 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.
- Being tested
- Pred Forte, EconoPred Plus, Prednisolone Acetate
- Keywords
- Glaucoma, Cataract
- Medical subject headings
- Glaucoma, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pred ForteDrug
Also called Econopred Plus
Four drops daily decreasing to once daily over four weeks.
EconoPred PlusDrug
Also called Pred Forte
Prednisolone Acetate four times daily decreasing to once daily over four weeks.
Prednisolone AcetateDrug
Also called Pred Forte, EconoPred Plus
Dosed four times daily decreasing to once daily over four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Pred Forte 1% | Active comparator | Pred Forte 1% dosed four times daily decreasing to once daily over four weeks. Receives: Drug: Pred Forte |
| EconoPred Plus 1% | Active comparator | EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks. Receives: Drug: EconoPred Plus |
| Prednisolone Acetate 1% | Active comparator | Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks. Receives: Drug: Prednisolone Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Flare at Resolution
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2006 (estimated)
- Study startSep 2002
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louis B Cantor, MD, Principal investigator, IUPUI/Clarian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345046
- Sponsor's protocol ID
- 0201-28
- Status last verified
- Mar 2014
- First submitted
- 26 Jun 2006
- Last updated
- 3 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Cantor LB. Ophthalmic generic drug approval process: implications for efficacy and safety. J Glaucoma. 1997 Oct;6(5):344-9. doi: 10.1097/00061198-199710000-00011. No abstract available.
PubMed 9327353Stoughton RB. Are generic formulations equivalent to trade name topical glucocorticoids? Arch Dermatol. 1987 Oct;123(10):1312-4.
PubMed 3662563Olsen EA. A double-blind controlled comparison of generic and trade-name topical steroids using the vasoconstriction assay. Arch Dermatol. 1991 Feb;127(2):197-201.
PubMed 1990984Casale TB, Azzam SM, Miller RE, Oren J. Demonstration of therapeutic equivalence of generic and innovator beclomethasone in seasonal allergic rhinitis. SAR Study Group. Ann Allergy Asthma Immunol. 1999 May;82(5):435-41. doi: 10.1016/s1081-1206(10)62717-2.
PubMed 10353573Nell H, Louw CM, Cyster H, Williams Z, Bardin PG, Joubert JR. Therapeutic equivalence study of two formulations (innovator v. generic) of beclomethasone dipropionate in adult asthmatic patients. S Afr Med J. 2001 Jan;91(1):51-6.
PubMed 11236299Apt L, Henrick A, Silverman LM. Patient compliance with use of topical ophthalmic corticosteroid suspensions. Am J Ophthalmol. 1979 Feb;87(2):210-4. doi: 10.1016/0002-9394(79)90145-4. No abstract available.
PubMed 434075Hille K, Hans J, Manderscheid T, Spang S, Ruprecht KW. [Laser flare in combined cataract and glaucoma surgery]. Ophthalmologe. 2001 Jan;98(1):47-53. doi: 10.1007/s003470170199. German.
PubMed 11220271Shah SM, Spalton DJ, Taylor JC. Correlations between laser flare measurements and anterior chamber protein concentrations. Invest Ophthalmol Vis Sci. 1992 Sep;33(10):2878-84.
PubMed 1526738Fiscella RG, Gutta R, Goldstein DB, Viana MAG. Comparison of PredForte Brand to generic Prednisolone acette and loteprednol etabonate (lotemax) in a Rabbit Model of Inflammation. American Academy of Ophthalmology 2001 Annual Meeting, Poster 73 Session 2001.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Three Different Formulations of Topical Prednisolone Acetate 1% for Control of Post Glaucoma and/or Cataract Surgery Inflammation.
- ClinicalTrials.gov ID
- NCT00345046
- Acronym / sponsor ID
- 0201-28
- Keywords
- Glaucoma, Cataract
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Sep 2002
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 27 Jun 2006 (estimated)
- Results
- Posted 21 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Generic prednisolone acetate 1% is less effective than Pred Forte 1% or Econopred Plus 1%.
Detailed description
Overall Study Design:
Structure:
This is a randomized, double-masked prospective study. The study medications will be masked and randomized by the outpatient pharmacy at Indiana University Hospital.
Duration:
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.
Controls:
Examiner, staff, and subjects are masked. Parallel group comparison.
Dosage/Dose Regimen/Instructions:
Subjects scheduled for glaucoma and/or cataract surgery will be recruited. 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. Subjects will be randomized to receive a dose of Pred Forte 1% (Allergan), Econopred Plus 1% (Alcon) or prednisolone acetate 1% (Falcon) four times a day starting immediately after finishing the surgery for two weeks, then twice a day for two more weeks. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pred Forte 1% | Active comparator | Drug: Pred FortePred Forte 1% dosed four times daily decreasing to once daily over four weeks. |
| EconoPred Plus 1% | Active comparator | Drug: EconoPred PlusEconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks. |
| Prednisolone Acetate 1% | Active comparator | Drug: Prednisolone AcetatePrednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
- Require use of ocular NSAID or systemic steroids.
- Have known allergy or sensitivity to the study medications or their components
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pred ForteAlso: Econopred PlusFour drops daily decreasing to once daily over four weeks. | Drug | Pred Forte 1% |
| EconoPred PlusAlso: Pred FortePrednisolone Acetate four times daily decreasing to once daily over four weeks. | Drug | EconoPred Plus 1% |
| Prednisolone AcetateAlso: Pred Forte, EconoPred PlusDosed four times daily decreasing to once daily over four weeks. | Drug | Prednisolone Acetate 1% |
Primary outcome
Percent Change in Flare at Resolution
Time frame: 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9327353Cantor LB. Ophthalmic generic drug approval process: implications for efficacy and safety. J Glaucoma. 1997 Oct;6(5):344-9. doi: 10.1097/00061198-199710000-00011. No abstract available.
- Background: PubMed 3662563Stoughton RB. Are generic formulations equivalent to trade name topical glucocorticoids? Arch Dermatol. 1987 Oct;123(10):1312-4.
- Background: PubMed 1990984Olsen EA. A double-blind controlled comparison of generic and trade-name topical steroids using the vasoconstriction assay. Arch Dermatol. 1991 Feb;127(2):197-201.
- Background: PubMed 10353573Casale TB, Azzam SM, Miller RE, Oren J. Demonstration of therapeutic equivalence of generic and innovator beclomethasone in seasonal allergic rhinitis. SAR Study Group. Ann Allergy Asthma Immunol. 1999 May;82(5):435-41. doi: 10.1016/s1081-1206(10)62717-2.
- Background: PubMed 11236299Nell H, Louw CM, Cyster H, Williams Z, Bardin PG, Joubert JR. Therapeutic equivalence study of two formulations (innovator v. generic) of beclomethasone dipropionate in adult asthmatic patients. S Afr Med J. 2001 Jan;91(1):51-6.
- Background: PubMed 434075Apt L, Henrick A, Silverman LM. Patient compliance with use of topical ophthalmic corticosteroid suspensions. Am J Ophthalmol. 1979 Feb;87(2):210-4. doi: 10.1016/0002-9394(79)90145-4. No abstract available.
- Background: PubMed 11220271Hille K, Hans J, Manderscheid T, Spang S, Ruprecht KW. [Laser flare in combined cataract and glaucoma surgery]. Ophthalmologe. 2001 Jan;98(1):47-53. doi: 10.1007/s003470170199. German.
- Background: PubMed 1526738Shah SM, Spalton DJ, Taylor JC. Correlations between laser flare measurements and anterior chamber protein concentrations. Invest Ophthalmol Vis Sci. 1992 Sep;33(10):2878-84.
- BackgroundFiscella RG, Gutta R, Goldstein DB, Viana MAG. Comparison of PredForte Brand to generic Prednisolone acette and loteprednol etabonate (lotemax) in a Rabbit Model of Inflammation. American Academy of Ophthalmology 2001 Annual Meeting, Poster 73 Session 2001.
- Electronic Orange BookLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis B Cantor, MD principal investigator
IUPUI/Clarian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pred Forte, EconoPred Plus and Prednisolone Acetate in people with Glaucoma and Cataract, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Flare at Resolution (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00345046, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.