Glaucoma, Open-angleNCT02754570
The Diurnal and Nocturnal Effect of Pilocarpine on Intraocular Pressure and Ocular Perfusion Pressure
A study testing Pilocarpine in people with Glaucoma, Open-angle and Hypertension, Ocular, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The aim of this study will be to determine the effects of pilocarpine as an adjunct medication to latanoprost monotherapy at multiple intervals throughout a 24-hour period and compare these effects to latanoprost alone. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Glaucoma, Open-angle, Hypertension, Ocular
- What is being tested?
- Pilocarpine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 21 Feb 2018
- Phase
- Interventional
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current confirmed diagnosis of:
- open angle glaucoma, or
- ocular hypertension including pigment dispersion glaucoma, and
- pseudoexfoliation glaucoma.
- Current use of topical latanoprost once a day in both eyes for at least 6 weeks
- any race/ethnicity
Who cannot join
- Females who are currently pregnant or planning to become pregnant during the study period
- Diagnosis of any other form of glaucoma other than open-angle
- Intraocular pressure readings of <14mmHg in either eye when measured during routine office visit in the past 12 months.
- Schaffer angle grade < 2 in either eye by gonioscopy
- Intraocular surgery within 6 months or laser within 3 months
- History of retinal tear or detachment in either eye
Show all 11Show fewer
- Active iritis in either eye as determined by most recent eye examination
- Patients who smoke or have irregular daily sleep patterns
- Patients who have started or changed glucocorticoids therapy in the last 3 months
- Patients who are currently using medical or recreational marijuana
- Any use of a non-FDA approved medication for glaucoma in the last 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver Eye Hospital
Denver, Colorado, 80045
About this study
The aim of this study will be to determine the effects of pilocarpine as an adjunct medication to latanoprost monotherapy at multiple intervals throughout a 24-hour period and compare these effects to latanoprost alone.
Read the detailed description
This study plans to learn more about the effect of pilocarpine on intraocular pressure and ocular perfusion pressure for a full twenty-four hour period.
In this study, the investigators seek to better characterize the knowledge base of the intraocular pressure (IOP) lowering effects of pilocarpine in patients with open angle glaucoma or ocular hypertension who are currently taking latanoprost. The goal is to define the potential additive effect of pilocarpine throughout a 24-hour period, not only for IOP, but for ocular perfusion pressure (defined as 2/3[diastolicBP + 1/3(systolicBP - diastolicBP)] - IOP). These data will allow to expand current knowledge of the effects of pilocarpine and help determine if this medication has a useful role as an adjunctive treatment in glaucoma.
- Conditions
- Glaucoma, Open-angle, Hypertension, Ocular
- Being tested
- Pilocarpine
- Keywords
- Open-angle glaucoma, Ocular hypertension, Latanoprost, Pilocarpine
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PilocarpineDrug
Also called Pilocarpine Hydrochloride
Pilocarpine will be administered 4 times in addition to latanoprost.
| Study group | Role | What they receive |
|---|---|---|
| Pilocarpine group | Experimental | Subjects with open-angle glaucoma and ocular hypertension that are currently taking latanoprost Receives: Drug: Pilocarpine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intraocular Pressure From Baseline at Visit 3
Subjects will be enrolled at the first visit. Patients already on latanoprost may proceed immediately with the second visit. Patients on a different prostaglandin analog medication will be switched to latanoprost for at least 6 weeks. At second visit, intraocular pressure and blood pressure will be measured every 2 hours for a 24-hour period. At any point over the next 4 weeks, another 24-hour visit will be performed. This time, a dose of pilocarpine 2% will be administered at 4 different times in addition to the latanoprost . As before, intraocular pressure and blood pressure will be measured every 2 hours. After visit 3, subjects will return to their prior treatment regimen. Change in the intraocular pressure from the second and the third visit will be determined. 8 diurnal readings and 4 nocturnal readings were averaged separately during both Visit 2 for the PGA Monotherapy and Visit 3 for Pilocarpine+PGA
Measured: Two 24-hour visits: Baseline/Visit 2; Up to week 4/Visit 3
Secondary outcomes (1)
Change in Ocular Perfusion Pressure
Ocular perfusion pressure will calculated from the intraocular pressure and blood pressure measurements. At Baseline/Visit 2, intraocular pressure and blood pressure will be measured every 2 hours for a 24-hour period. At any point over the next 4 weeks, another 24-hour visit (Visit 3) will be performed. This time, a dose of pilocarpine 2% will be administered at 4 different times in addition to the latanoprost (PGA monotherapy). As before, intraocular pressure and blood pressure will be measured every 2 hours. 8 diurnal readings and 4 nocturnal readings were averaged separately during both Visit 2 for the PGA Monotherapy and Visit 3 for Pilocarpine+PGA
Measured: Two 24-hour visits: Baseline/Visit 2; Up to week 4/Visit 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2017
- Study completion21 Feb 2018
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.
- Other trials for Glaucoma, Open-angleStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leonard Seibold, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754570
- Sponsor's protocol ID
- 15-1972
- Other IDs
- UL1TR001082
- Status last verified
- Oct 2019
- First submitted
- 20 Apr 2016
- Last updated
- 7 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diurnal and Nocturnal Effect of Pilocarpine on Intraocular Pressure and Ocular Perfusion Pressure
- ClinicalTrials.gov ID
- NCT02754570
- Acronym / sponsor ID
- 15-1972
- Conditions
- Glaucoma, Open-angle, Hypertension, Ocular
- Keywords
- Open-angle glaucoma, Ocular hypertension, Latanoprost, Pilocarpine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- 21 Feb 2018 (actual)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Posted 7 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study will be to determine the effects of pilocarpine as an adjunct medication to latanoprost monotherapy at multiple intervals throughout a 24-hour period and compare these effects to latanoprost alone.
Detailed description
This study plans to learn more about the effect of pilocarpine on intraocular pressure and ocular perfusion pressure for a full twenty-four hour period.
In this study, the investigators seek to better characterize the knowledge base of the intraocular pressure (IOP) lowering effects of pilocarpine in patients with open angle glaucoma or ocular hypertension who are currently taking latanoprost. The goal is to define the potential additive effect of pilocarpine throughout a 24-hour period, not only for IOP, but for ocular perfusion pressure (defined as 2/3[diastolicBP + 1/3(systolicBP - diastolicBP)] - IOP). These data will allow to expand current knowledge of the effects of pilocarpine and help determine if this medication has a useful role as an adjunctive treatment in glaucoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilocarpine group | Experimental | Drug: PilocarpineSubjects with open-angle glaucoma and ocular hypertension that are currently taking latanoprost |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Current confirmed diagnosis of:
- Current use of topical latanoprost once a day in both eyes for at least 6 weeks
- any race/ethnicity
Key exclusion criteria (11 listed)
- Females who are currently pregnant or planning to become pregnant during the study period
- Diagnosis of any other form of glaucoma other than open-angle
- Intraocular pressure readings of <14mmHg in either eye when measured during routine office visit in the past 12 months.
- Schaffer angle grade < 2 in either eye by gonioscopy
- Intraocular surgery within 6 months or laser within 3 months
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 |
|---|---|---|
| PilocarpineAlso: Pilocarpine HydrochloridePilocarpine will be administered 4 times in addition to latanoprost. | Drug | Pilocarpine group |
Primary outcome
Change in Intraocular Pressure From Baseline at Visit 3
Time frame: Two 24-hour visits: Baseline/Visit 2; Up to week 4/Visit 3
Subjects will be enrolled at the first visit. Patients already on latanoprost may proceed immediately with the second visit. Patients on a different prostaglandin analog medication will be switched to latanoprost for at least 6 weeks. At second visit, intraocular pressure and blood pressure will be measured every 2 hours for a 24-hour period. At any point over the next 4 weeks, another 24-hour visit will be performed. This time, a dose of pilocarpine 2% will be administered at 4 different times in addition to the latanoprost . As before, intraocular pressure and blood pressure will be measured every 2 hours. After visit 3, subjects will return to their prior treatment regimen. Change in the intraocular pressure from the second and the third visit will be determined. 8 diurnal readings and 4 nocturnal readings were averaged separately during both Visit 2 for the PGA Monotherapy and Visit 3 for Pilocarpine+PGA
1 secondary outcome
Change in Ocular Perfusion Pressure
Time frame: Two 24-hour visits: Baseline/Visit 2; Up to week 4/Visit 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Glaucoma, Open-angle
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
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.
Leonard Seibold, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilocarpine in people with Glaucoma, Open-angle and Hypertension, Ocular, run by University of Colorado, Denver 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 6 inclusion and 11 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 7 Nov 2019. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2019). 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?
Change in Intraocular Pressure From Baseline at Visit 3 (time frame: Two 24-hour visits: Baseline/Visit 2; Up to week 4/Visit 3). 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 7 Nov 2019.