CataractPhase 4NCT00355446
Bioavailability of Bimatoprost Ophthalmic Solution in Human Aqueous.
A Phase 4 study testing Bimatoprost 0.03% in people with Cataract, run by Indiana University at 4 sites in United States.
Trial summary
The purpose of this study is to assay human aqueous for bimatoprost and the presence of any metabolites, especially prostaglandin analogs. Hypothesis:Bimatoprost is not metabolized to a prostaglandin F-2-alpha analog in human eyes Bimatoprost levels in human aqueous peak approximately three hours post dosing Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Bimatoprost 0.03%
- How many people
- 48 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2001to Oct 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- All subjects must:
- Be willing and able to provide written Informed Consent.
- Be able and willing to follow instructions 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 for which they have elected to undergo cataract surgery..
Who cannot join
- No subject may:
- 1. Have any contraindication to use of a prostaglandin analog or prostamide derivative.
- 3. Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study parameters (such as: uveitis, ocular infection, or severe dry eye). Patients with mild chronic blepharitis, age-related macular degeneration, background diabetic retinopathy may be enrolled at the discretion of the investigator.
- 4. Have laser or any other intraocular surgery within the past three months. 5. Require use of ocular medications (including glaucoma medications), except intermittent use of artificial tears. Patients may not have a history of ever having used a prostaglandin analog topically.
- 6. Have known allergy or sensitivity to the study medications or their components 7. Have corneal abnormalities that would interfere with the ability to obtain an adequate sample safely or have a shallow anterior which would make obtaining an aqueous sample difficult at the time of surgery in the opinion of the investigator.
- 8. Be concurrently enrolled in an investigational drug or device study or participation within the last 30 days in any investigational drug or device study.
- 9. 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).
- 10. 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
4 sites in 1 country.
United States4 sites
University Hospital
Indianapolis, Indiana, 46202
Veterans Affairs Medical Center
Indianapolis, Indiana, 46202
Wishard Memorial Hospital
Indianapolis, Indiana, 46202
IU Eye at Carmel
Indianapolis, Indiana, 46290
About this study
Official title: Bioavailabilty of Bimatoprost Ophthalmic Solution in Human Aqueous.
The purpose of this study is to assay human aqueous for bimatoprost and the presence of any metabolites, especially prostaglandin analogs. Hypothesis:Bimatoprost is not metabolized to a prostaglandin F-2-alpha analog in human eyes
- Bimatoprost levels in human aqueous peak approximately three hours post dosing
Read the detailed description
The purpose of this study is to assay human aqueous for bimatoprost and the presence of any metabolites, especially prostaglandin analogs
- Conditions
- Cataract
- Being tested
- Bimatoprost 0.03%
- Keywords
- Cataract, Human Aqueous
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bimatoprost 0.03%Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Bimatoprost free acid in human aqueous
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2006 (estimated)
- Study startJul 2001
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CataractStudies 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
- Enrolment
- 48 participants
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Investigators
- Louis B Cantor, MD, Principal investigator, IUPUI/Clarian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355446
- Sponsor's protocol ID
- 0106-24
- Status last verified
- Oct 2007
- First submitted
- 20 Jul 2006
- Last updated
- 17 Oct 2007
- Results posted
- No
Publications
Cantor LB, Donnenfeld E, Katz LJ, Gee WL, Finley CD, Lakhani VK, Hoop J, Flarty K. Penetration of ofloxacin and ciprofloxacin into the aqueous humor of eyes with functioning filtering blebs: a randomized trial. Arch Ophthalmol. 2001 Sep;119(9):1254-7. doi: 10.1001/archopht.119.9.1254.
PubMed 11545629Sjoquist B, Basu S, Byding P, Bergh K, Stjernschantz J. The pharmacokinetics of a new antiglaucoma drug, latanoprost, in the rabbit. Drug Metab Dispos. 1998 Aug;26(8):745-54.
PubMed 9698288Basu S, Sjoquist B, Stjernschantz J, Resul B. Corneal permeability to and ocular metabolism of phenyl substituted prostaglandin esters in vitro. Prostaglandins Leukot Essent Fatty Acids. 1994 Apr;50(4):161-8. doi: 10.1016/0952-3278(94)90139-2.
PubMed 8022849
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailabilty of Bimatoprost Ophthalmic Solution in Human Aqueous.
- ClinicalTrials.gov ID
- NCT00355446
- Acronym / sponsor ID
- 0106-24
- Conditions
- Cataract
- Keywords
- Cataract, Human Aqueous
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Jul 2001
- Study completion
- Oct 2004
- First posted
- 24 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assay human aqueous for bimatoprost and the presence of any metabolites, especially prostaglandin analogs. Hypothesis:Bimatoprost is not metabolized to a prostaglandin F-2-alpha analog in human eyes
- Bimatoprost levels in human aqueous peak approximately three hours post dosing
Detailed description
The purpose of this study is to assay human aqueous for bimatoprost and the presence of any metabolites, especially prostaglandin analogs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All subjects must:
Key exclusion criteria (8 listed)
- No subject may:
- 1. Have any contraindication to use of a prostaglandin analog or prostamide derivative.
- 3. Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study parameters (such as: uveitis, ocular infection, or severe dry eye). Patients with mild chronic blepharitis, age-related macular degeneration, background diabetic retinopathy may be enrolled at the discretion of the investigator.
- 4. Have laser or any other intraocular surgery within the past three months. 5. Require use of ocular medications (including glaucoma medications), except intermittent use of artificial tears. Patients may not have a history of ever having used a prostaglandin analog topically.
- 6. Have known allergy or sensitivity to the study medications or their components 7. Have corneal abnormalities that would interfere with the ability to obtain an adequate sample safely or have a shallow anterior which would make obtaining an aqueous sample difficult at the time of surgery in the opinion of the investigator.
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 |
|---|---|---|
| Bimatoprost 0.03% | Drug | – |
Primary outcome
Bimatoprost free acid in human aqueous
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2007.
- Background: PubMed 11545629Cantor LB, Donnenfeld E, Katz LJ, Gee WL, Finley CD, Lakhani VK, Hoop J, Flarty K. Penetration of ofloxacin and ciprofloxacin into the aqueous humor of eyes with functioning filtering blebs: a randomized trial. Arch Ophthalmol. 2001 Sep;119(9):1254-7. doi: 10.1001/archopht.119.9.1254.
- Background: PubMed 9698288Sjoquist B, Basu S, Byding P, Bergh K, Stjernschantz J. The pharmacokinetics of a new antiglaucoma drug, latanoprost, in the rabbit. Drug Metab Dispos. 1998 Aug;26(8):745-54.
- Background: PubMed 8022849Basu S, Sjoquist B, Stjernschantz J, Resul B. Corneal permeability to and ocular metabolism of phenyl substituted prostaglandin esters in vitro. Prostaglandins Leukot Essent Fatty Acids. 1994 Apr;50(4):161-8. doi: 10.1016/0952-3278(94)90139-2.
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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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bimatoprost 0.03% in people with Cataract, run by Indiana University at 4 sites 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 5 inclusion and 8 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 17 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bimatoprost free acid in human aqueous. 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 NCT00355446, which also lists 3 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 17 Oct 2007.