To See the Safety and Efficacy of the Topical Latanoprost Compared With Topical Brimonidine in the Treatment of the Primary Open Angle Glaucoma PatientsPhase 2NCT04205201
The Effectiveness of Topical Latanoprost Compared With Topical Brimonidine in the Treatment of the Primary Open Angle Glaucoma
A Phase 2 study testing Drugs, Investigational in people with To See the Safety and Efficacy of the Topical Latanoprost Compared With Topical Brimonidine in the Treatment of the Primary Open Angle Glaucoma Patients, run by Chittagong Medical College at 2 sites in Bangladesh.
Trial summary
Outpatient department of cmch, ceitc,cimch POAG patients enrolled for the study. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- To See the Safety and Efficacy of the Topical Latanoprost Compared With Topical Brimonidine in the Treatment of the Primary Open Angle Glaucoma Patients
- What is being tested?
- Drugs, Investigational
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesBangladesh
- Study dates
- 25 Jun 2018to 5 Oct 2019
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- IOP 22_34mmof Hg,newly diagnosed case, bilateral POAG patients Patients.
Who cannot join
- pregnant and lactating women, infection, any eye surgery.
Trial locations and contacts
2 sites in 1 country.
Bangladesh2 sites
Facuity of basic scienceand para clinican science
Chittagong, Chokhbazar
Facuity of basic science and para clinical science
Dhaka, Chittagong
About this study
Outpatient department of cmch, ceitc,cimch POAG patients enrolled for the study.
- Being tested
- Drugs, Investigational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drugs, InvestigationalDrug
Also called Brimonidine
To see the safety and efficacy of topical latanoprost compared with topical brimonidine in the treatment of the primary open angle
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Latanoprost Receives: Drug: Drugs, Investigational |
| Group B | Other | Brimonidine Receives: Drug: Drugs, Investigational |
What is being measured
The primary outcome is the main question the study is designed to answer.
More than 20% IOP reduction
From baseline to month 3
Measured: 0_3 months
Secondary outcomes (1)
Adverse reaction
Record every follow up period baseline to month 3.
Measured: O_3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start25 Jun 2018
- Primary completion24 Sep 2019
- Study completion5 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To See the Safety and Efficacy of the Topical Latanoprost Compared With Topical Brimonidine in the Treatment of the Primary Open Angle Glaucoma PatientsStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chittagong Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abul Khayer, Chittagong Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205201
- Sponsor's protocol ID
- CMC/PG/2018/1828
- Status last verified
- Dec 2019
- First submitted
- 17 Dec 2019
- Last updated
- 26 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Topical Latanoprost Compared With Topical Brimonidine in the Treatment of the Primary Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT04205201
- Acronym / sponsor ID
- CMC/PG/2018/1828
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Chittagong Medical CollegeUniversity, hospital or other
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 24 Sep 2019 (actual)
- Study completion
- 5 Oct 2019 (actual)
- First posted
- 19 Dec 2019 (actual)
- 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.
Outpatient department of cmch, ceitc,cimch POAG patients enrolled for the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Drugs, InvestigationalLatanoprost |
| Group B | Other | Drug: Drugs, InvestigationalBrimonidine |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- IOP 22_34mmof Hg,newly diagnosed case, bilateral POAG patients Patients.
Key exclusion criteria (1 listed)
- pregnant and lactating women, infection, any eye surgery.
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 |
|---|---|---|
| Drugs, InvestigationalAlso: BrimonidineTo see the safety and efficacy of topical latanoprost compared with topical brimonidine in the treatment of the primary open angle | Drug | Group A, Group B |
Primary outcome
More than 20% IOP reduction
Time frame: 0_3 months
From baseline to month 3
1 secondary outcome
Adverse reaction
Time frame: O_3 months
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 26 Dec 2019.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Drugs, Investigational in people with To See the Safety and Efficacy of the Topical Latanoprost Compared With Topical Brimonidine in the Treatment of the Primary Open Angle Glaucoma Patients, run by Chittagong Medical College at 2 sites in Bangladesh.
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 1 inclusion and 1 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 26 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bangladesh. 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 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?
More than 20% IOP reduction (time frame: 0_3 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 26 Dec 2019.