GlaucomaPhase 2NCT00579969
Comparison of Latanoprost Vs. Timolol
A Phase 2 study testing Latanoprost and Timolol in people with Glaucoma, run by University of Nebraska at 1 site in United States.
Trial summary
The primary purpose of this study is to show, through a controlled masked clinical study of subjects with ocular hypertension (OHT), that latanoprost increases the low uveoscleral drainage of aqueous humor back to normal levels, and timolol maleate reduces the formation of aqueous humor below normal. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Latanoprost and Timolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Oct 2008
- Phase
- Phase 2
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Minimum of nineteen (19) years of age.
- Diagnosed with bilateral ocular hypertension or primary open angle glaucoma for at least six months prior to screen visit.
- IOP of 20-35 mmHg in both eyes and not more than 5 mmHg difference between eyes at the Baseline 0800 ±1 hour IOP measurement.
- Willing and able to provide informed consent.
- Able to adhere to treatment/visit plan.
Who cannot join
- Systemic Conditions:
- History of severe, unstable or uncontrolled cardiovascular, hepatic or renal disease.
- History of bronchial asthma or chronic obstructive pulmonary disease.
- Allergies to sulfa drugs.
- Ocular Conditions:
- Chronic or recurrent severe ocular inflammatory disease.
Show all 20Show fewer
- Ocular infection or inflammation within three (3) months of the study visit.
- Subjects currently treated with more than two ocular hypotensive medications.
- Subjects having previous exposure to: adrenergic antagonists, topical prostaglandin analogues (including latanoprost, unoprostone, travoprost and bimatoprost) within four (4) weeks of the baseline visit; adrenergic agonists within two (2) weeks of the baseline visit; and cholinergic agonists and carbonic anhydrase inhibitors within five (5) days of the baseline visit.
- History of any severe ocular pathology that would preclude the administration of a topical prostaglandin or beta-blocker.
- History of severe or serious hypersensitivity to topical or systemic prostaglandins or beta-blockers.
- Intraocular pressures less than 20 mmHg when off all ocular medications.
- Cornea thickness greater than 600 microns.
- Women:
- Women of childbearing potential who are sexually active, or plan to become sexually active, and don't have a vasectomized partner, must agree to use at least one of the following acceptable contraceptive methods: condoms (male or female with or without a spermicidal agent, a diaphragm or cervical cap with spermicide, an intrauterine device (IUD) or hormonal-based contraception. Women of childbearing potential are defined as women who are not surgically sterile or not postmenopausal (at least 12 months without menstrual period).
- Nursing mothers.
- Pregnancy
- General
- Subjects less than nineteen (19) years of age.
- Therapy with another investigational agent within 30 days of Screening Visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
UNMC Department of Ophthalmolgy and Visual Sciences
Omaha, Nebraska, 68198-5540
About this study
Official title: Comparison of the Effects of Latanoprost and Timolol on Aqueous Humor Dynamics in Ocular Hypertensive Patients
The primary purpose of this study is to show, through a controlled masked clinical study of subjects with ocular hypertension (OHT), that latanoprost increases the low uveoscleral drainage of aqueous humor back to normal levels, and timolol maleate reduces the formation of aqueous humor below normal. Both of these mechanisms will effectively reduce intraocular pressure (IOP).
The secondary purpose is to assess the effects of both latanoprost and timolol maleate on the fluorophotometric outflow facility, and episcleral venous pressure and on all parameters over time.
Read the detailed description
A recent publication by our laboratory has shown that patients with ocular hypertension (OHT) have reduced uveoscleral outflow and reduced trabecular outflow facility compared with healthy age-matched controls. These changes are the cause of the elevated intraocular pressure (IOP). Aqueous flow rate did not change in these patients. It is logical to assume that it would be more efficacious to treat OHT patients with drugs that reduce IOP by increasing uveoscleral outflow (which is abnormally low) than with drugs that reduce aqueous flow (which is normal in OHT).
The primary purpose of this study is to show, through a controlled masked clinical study of OHT patients, that latanoprost increases the low uveoscleral drainage of aqueous humor (Fu) back to normal levels, and timolol maleate reduces the formation of aqueous humor (Fa) below normal. Both of these mechanisms will effectively reduce IOP.
The secondary purpose is to assess the effects of both latanoprost and timolol maleate on the fluorophotometric outflow facility (Cflu), and episcleral venous pressure (Pev) and on all parameters over time.
Subjects eligible to participate will be at least 19 years of age and diagnosed with bilateral ocular hypertension or primary open angle glaucoma and have intraocular pressure between 20 and 35 mmHg in both eyes on Day 0. Subjects will be treated with either latanoprost or timolol for 6 weeks and then crossover and be treated similarly with the alternate drug for an additional 6 weeks. There will be a screening visit and a total of 6 study visits in which aqueous humor flow, uveoscleral outflow, and fluorophotometric outflow facility will be determined using an instrument called a fluorophotometer. The fluorophotometer scans the eye for fluorescein dye allowing the investigator to measure and calculate the above variables. There will be 7 scans taken during each study day and additionally IOP will be measured after the completion of each scan. An Exit exam will be performed at the time of exit to ensure the ocular health of the subject.
Subjects will be monitored for adverse events throughout the course of the study and subjects may discontinue from the study at any time for any reason, or may be discontinued if, in the opinion of the investigator, there is a risk to the subject.
- Conditions
- Glaucoma
- Being tested
- Latanoprost, Timolol
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LatanoprostDrug
dosage form:eye drops, dosage: One drop in each eye twice a day
TimololDrug
dosage form:eye drops, dosage: One drop in each eye twice a day
| Study group | Role | What they receive |
|---|---|---|
| Latanoprost Effects on Aqueous Humor Dynamics in Ocular Hypertensive Patients | Experimental | Evaluating the Effects of Latanoprost on Aqueous Humor Dynamics in Ocular Hypertensive Patients (prostaglandin analogue) Receives: Drug: Latanoprost |
| Timolol Effects on Aqueous Humor Dynamics in Ocular Hypertensive Patients | Experimental | Evaluating the Effects of Timolol on Aqueous Humor Dynamics in Ocular Hypertensive Patients (prostaglandin analogue) Receives: Drug: Timolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Latanoprost and Timolol in lowering ocular pressure
Two drugs, Latanoprost and Timolol, will be compared in ocular hypertensive patients in their ability to lower ocular pressure at six months using a Goldmann applanation tonometer (GAT).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study startDec 2003
- Primary completionOct 2008
- Study completionOct 2008
Why it stopped: Study stopped and data not analyzed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carl B Camras, MD, Principal investigator, UNMC Department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00579969
- Sponsor's protocol ID
- 0335-03-XX
- Status last verified
- Dec 2023
- First submitted
- 18 Dec 2007
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Latanoprost and Timolol on Aqueous Humor Dynamics in Ocular Hypertensive Patients
- ClinicalTrials.gov ID
- NCT00579969
- Acronym / sponsor ID
- 0335-03-XX
- Conditions
- Glaucoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped and data not analyzed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- Dec 2003
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 24 Dec 2007 (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 primary purpose of this study is to show, through a controlled masked clinical study of subjects with ocular hypertension (OHT), that latanoprost increases the low uveoscleral drainage of aqueous humor back to normal levels, and timolol maleate reduces the formation of aqueous humor below normal. Both of these mechanisms will effectively reduce intraocular pressure (IOP).
The secondary purpose is to assess the effects of both latanoprost and timolol maleate on the fluorophotometric outflow facility, and episcleral venous pressure and on all parameters over time.
Detailed description
A recent publication by our laboratory has shown that patients with ocular hypertension (OHT) have reduced uveoscleral outflow and reduced trabecular outflow facility compared with healthy age-matched controls. These changes are the cause of the elevated intraocular pressure (IOP). Aqueous flow rate did not change in these patients. It is logical to assume that it would be more efficacious to treat OHT patients with drugs that reduce IOP by increasing uveoscleral outflow (which is abnormally low) than with drugs that reduce aqueous flow (which is normal in OHT).
The primary purpose of this study is to show, through a controlled masked clinical study of OHT patients, that latanoprost increases the low uveoscleral drainage of aqueous humor (Fu) back to normal levels, and timolol maleate reduces the formation of aqueous humor (Fa) below normal. Both of these mechanisms will effectively reduce IOP.
The secondary purpose is to assess the effects of both latanoprost and timolol maleate on the fluorophotometric outflow facility (Cflu), and episcleral venous pressure (Pev) and on all parameters over time.
Subjects eligible to participate will be at least 19 years of age and diagnosed with bilateral ocular hypertension or primary open angle glaucoma and have intraocular pressure between 20 and 35 mmHg in both eyes on Day 0. Subjects will be treated with either latanoprost or timolol for 6 weeks and then crossover and be treated similarly with the alternate drug for an additional 6 weeks. There will be a screening visit and a total of 6 study visits in which aqueous humor flow, uveoscleral outflow, and fluorophotometric outflow facility will be determined using an instrument called a fluorophotometer. The fluorophotometer scans the eye for fluorescein dye allowing the investigator to measure and calculate the above variables. There will be 7 scans taken during each study day and additionally IOP will be measured after the completion of each scan. An Exit exam will be performed at the time of exit to ensure the ocular health of the subject.
Subjects will be monitored for adverse events throughout the course of the study and subjects may discontinue from the study at any time for any reason, or may be discontinued if, in the opinion of the investigator, there is a risk to the subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Latanoprost Effects on Aqueous Humor Dynamics in Ocular Hypertensive Patients | Experimental | Drug: LatanoprostEvaluating the Effects of Latanoprost on Aqueous Humor Dynamics in Ocular Hypertensive Patients (prostaglandin analogue) |
| Timolol Effects on Aqueous Humor Dynamics in Ocular Hypertensive Patients | Experimental | Drug: TimololEvaluating the Effects of Timolol on Aqueous Humor Dynamics in Ocular Hypertensive Patients (prostaglandin analogue) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Minimum of nineteen (19) years of age.
- Diagnosed with bilateral ocular hypertension or primary open angle glaucoma for at least six months prior to screen visit.
- IOP of 20-35 mmHg in both eyes and not more than 5 mmHg difference between eyes at the Baseline 0800 ±1 hour IOP measurement.
- Willing and able to provide informed consent.
- Able to adhere to treatment/visit plan.
Key exclusion criteria (20 listed)
- History of severe, unstable or uncontrolled cardiovascular, hepatic or renal disease.
- History of bronchial asthma or chronic obstructive pulmonary disease.
- Allergies to sulfa drugs.
- Chronic or recurrent severe ocular inflammatory disease.
- Ocular infection or inflammation within three (3) months of the study visit.
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 |
|---|---|---|
| Latanoprostdosage form:eye drops, dosage: One drop in each eye twice a day | Drug | Latanoprost Effects on Aqueous Humor Dynamics in Ocular Hypertensive Patients |
| Timololdosage form:eye drops, dosage: One drop in each eye twice a day | Drug | Timolol Effects on Aqueous Humor Dynamics in Ocular Hypertensive Patients |
Primary outcome
Comparison of Latanoprost and Timolol in lowering ocular pressure
Time frame: 6 months
Two drugs, Latanoprost and Timolol, will be compared in ocular hypertensive patients in their ability to lower ocular pressure at six months using a Goldmann applanation tonometer (GAT).
Results and safety
The study was stopped early (reason given: Study stopped and data not analyzed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
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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.
Carl B Camras, MD principal investigator
UNMC Department of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Latanoprost and Timolol in people with Glaucoma, run by University of Nebraska 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 5 inclusion and 20 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: stopped early, as of the sponsor's last update on 21 Dec 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Study stopped and data not analyzed). Results are not available in the source record.
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?
Comparison of Latanoprost and Timolol in lowering ocular pressure (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2023.