PresbyopiaPhase 1NCT05006898
Compound to Control Presbyopia Symptoms
A Phase 1 study of Presbyopia, run by Optall Vision at 1 site in Mexico.
Trial summary
Low dose compose to control presbyopia symptoms Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Presbyopia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jun 2020to 1 Jul 2020
- Phase
- Phase 1
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- Presbyopic
- 40 - 59 years
Who cannot join
- Diabetics
- Previous eye surgery
- Previous eye disease
- > 0.50 myopia
- > 1.5 hyperopia or astigmatism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Synergistic Use of Pilocarpine-Brimonidine-Oxymetazoline to Control Presbyopia Symptoms
Low dose compose to control presbyopia symptoms
Read the detailed description
A los dose compound including pilocarpine, brimonidine and oxymetazoline was use to control presbyopia symptoms compared to pilocarpine and brimonidine in low doses.
- Conditions
- Presbyopia
- Being tested
- PBO to control presbyopia symptoms
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBO to control presbyopia symptomsCombination product
Also called Pilocarpine, Brimonidine, Oxymetazoline
Low dose PBO to control presbyopia symptoms
| Study group | Role | What they receive |
|---|---|---|
| PBO Investigational drug | Experimental | Pilocarpine, brimonidine, oxymetazoline combined with hyaluronic acid and bromfenac combined in an ophthalmic solution to be randomly instilled in one eye. Receives: Combination Product: PBO to control presbyopia symptoms |
| Pilocarpine | Active comparator | Pilocarpine was instilled in the other oye. Receives: Combination Product: PBO to control presbyopia symptoms |
| Brimonidine | Active comparator | Brimonidine was instilled in the other eye. Receives: Combination Product: PBO to control presbyopia symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jaeger notation near uncorrected visual acuity change
Number of lines improved 1 hour after drug instillation
Measured: 1 hour
Comparison of PBO compound Jaeger notation improvement vs Pilocarpine or Brimonidine alone
Number of lines improve comparing PBO compound vs Pilocarpine or Brimonidine
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start1 Jun 2020
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbyopiaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilocarpine, brimonidine, oxymetazoline (PBO) compound was instilled in the non-dominant eye of presbyopic patients, while in the dominant eye pilocarpine or brimonidine were instilled.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optall Vision
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cesar Alejandro Sanchez Galeana, Optall Vision
- Investigators
- Cesar Alejandro S Galeana, Principal investigator, Optall Vision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006898
- Sponsor's protocol ID
- PBOPC01
- Status last verified
- Aug 2021
- First submitted
- 9 Jun 2021
- Last updated
- 19 Aug 2021
- 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 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synergistic Use of Pilocarpine-Brimonidine-Oxymetazoline to Control Presbyopia Symptoms
- ClinicalTrials.gov ID
- NCT05006898
- Acronym / sponsor ID
- PBOPC01
- Conditions
- Presbyopia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Optall VisionUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 16 Aug 2021 (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.
Low dose compose to control presbyopia symptoms
Detailed description
A los dose compound including pilocarpine, brimonidine and oxymetazoline was use to control presbyopia symptoms compared to pilocarpine and brimonidine in low doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Pilocarpine, brimonidine, oxymetazoline (PBO) compound was instilled in the non-dominant eye of presbyopic patients, while in the dominant eye pilocarpine or brimonidine were instilled.
| Arm | Type | Receives |
|---|---|---|
| PBO Investigational drug | Experimental | Combination Product: PBO to control presbyopia symptomsPilocarpine, brimonidine, oxymetazoline combined with hyaluronic acid and bromfenac combined in an ophthalmic solution to be randomly instilled in one eye. |
| Pilocarpine | Active comparator | Combination Product: PBO to control presbyopia symptomsPilocarpine was instilled in the other oye. |
| Brimonidine | Active comparator | Combination Product: PBO to control presbyopia symptomsBrimonidine was instilled in the other eye. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy
- Presbyopic
- 40 - 59 years
Key exclusion criteria (5 listed)
- Diabetics
- Previous eye surgery
- Previous eye disease
- > 0.50 myopia
- > 1.5 hyperopia or astigmatism
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 |
|---|---|---|
| PBO to control presbyopia symptomsAlso: Pilocarpine, Brimonidine, OxymetazolineLow dose PBO to control presbyopia symptoms | Combination product | Brimonidine, PBO Investigational drug, Pilocarpine |
Primary outcome
Jaeger notation near uncorrected visual acuity change
Time frame: 1 hour
Number of lines improved 1 hour after drug instillation
Comparison of PBO compound Jaeger notation improvement vs Pilocarpine or Brimonidine alone
Time frame: 1 hour
Number of lines improve comparing PBO compound vs Pilocarpine or Brimonidine
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 19 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Cesar Alejandro S Galeana principal investigator
Optall Vision
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Presbyopia, run by Optall Vision at 1 site in Mexico.
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 3 inclusion and 5 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 19 Aug 2021. 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 Mexico. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Jaeger notation near uncorrected visual acuity change (time frame: 1 hour). The study lists 2 primary outcomes in all. 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 19 Aug 2021.