PresbyopiaPhase 1PBOHBNCT05001243
Comparison of a Compound With Pilocarpine and Brimonidine to Improve Near Vision in Healthy Presbyopic Patients
A Phase 1 study testing Compound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac, Pilocarpine Hydrochloride and Brimonidine Tartrate in people with Presbyopia, run by Optall Vision at 1 site in Mexico.
Trial summary
Safety and Efficacy of Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac (PBOHB) ophthalmic compound compared to Pilocarpine and Brimonidine to improve uncorrected near vision in healthy presbyopic patients one hour after instillation. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Presbyopia
- What is being tested?
- Compound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac, Pilocarpine Hydrochloride and Brimonidine Tartrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteMexico
- Study dates
- 10 Aug 2021to 10 Sep 2021
- 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.
Mexico1 site, 1 recruiting
- Recruiting
Optall Vision
Mexico City, 01090
Cesar Alejandro S Galeana, MD, 5541851511, optallvision@gmail.com
About this study
Official title: Comparison of Pilocarpine, Brimonidine, Oxymetazoline, Hialuronic Acid, Bromfenac Ophthalmic Compound With Pilocarpine and Brimonidine to Improve Uncorrected Visual Acuity in Healthy Presbyopic Individuals
Safety and Efficacy of Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac (PBOHB) ophthalmic compound compared to Pilocarpine and Brimonidine to improve uncorrected near vision in healthy presbyopic patients one hour after instillation.
Read the detailed description
To determine the safety and efficacy of a novel pharmacological compound of Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac (PBOHB) to improve uncorrected near vision in healthy presbyopic patients compared to Pilocarpine and Brimonidine one hour after binocular instillation.
- Conditions
- Presbyopia
- Being tested
- Compound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac, Pilocarpine Hydrochloride, Brimonidine Tartrate
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, BromfenacDrug
Also called PBOHB
PBOHB to improve uncorrected near vision in healthy presbyopic patients
Pilocarpine HydrochlorideDrug
Also called Pil
Apply in the fellow eye
Brimonidine TartrateDrug
Also called Brimonidine
Apply in the fellow eye
| Study group | Role | What they receive |
|---|---|---|
| Experimental PBOHB | Experimental | Pilocarpine, brimonidine, Oxymetazoline combined with Hyaluronic Acid and Bromfenac combined in an ophthalmic solution to be randomly instilled in one eye. Receives: Drug: Pilocarpine Hydrochloride; Drug: Brimonidine Tartrate |
| Pilocarpine 5 mgs | Active comparator | Pilocarpine was instilled in the other oye. Receives: Drug: Compound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac |
| Brimonidine 0.5 mgs | Active comparator | Brimonidine was instilled in the other eye. Receives: Drug: Compound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of eyes improving 3 lines or more near visual acuity
Eyes instilled with PBOHB
Measured: 1 hour
Eyes improving 3 lines or more near visual acuity
Eyes instilled with Pilocarpine
Measured: 1 hour
Eyes improving 3 lines or more near VA
Eyes instilled with 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 posted11 Aug 2021
- Study start10 Aug 2021
- Primary completion30 Aug 2021 (estimated)
- Study completion10 Sep 2021 (estimated)
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
- Single Group Assignment To determine safety and efficacy of a Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic Acid, Bromfenac compound compared to Brimonidine and Pilocarpine to improve near uncorrected vision in healthy presbyopic patients
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 11 participants (estimated)
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, MD, Principal investigator, Optall Vision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001243
- Sponsor's protocol ID
- PBOCP3
- Acronym
- PBOHB
- Status last verified
- Aug 2021
- First submitted
- 4 Aug 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
- Comparison of Pilocarpine, Brimonidine, Oxymetazoline, Hialuronic Acid, Bromfenac Ophthalmic Compound With Pilocarpine and Brimonidine to Improve Uncorrected Visual Acuity in Healthy Presbyopic Individuals
- ClinicalTrials.gov ID
- NCT05001243
- Acronym / sponsor ID
- PBOHB / PBOCP3
- Conditions
- Presbyopia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Optall VisionUniversity, hospital or other
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 10 Sep 2021 (estimated)
- First posted
- 11 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.
Safety and Efficacy of Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac (PBOHB) ophthalmic compound compared to Pilocarpine and Brimonidine to improve uncorrected near vision in healthy presbyopic patients one hour after instillation.
Detailed description
To determine the safety and efficacy of a novel pharmacological compound of Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac (PBOHB) to improve uncorrected near vision in healthy presbyopic patients compared to Pilocarpine and Brimonidine one hour after binocular instillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Single Group Assignment To determine safety and efficacy of a Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic Acid, Bromfenac compound compared to Brimonidine and Pilocarpine to improve near uncorrected vision in healthy presbyopic patients
| Arm | Type | Receives |
|---|---|---|
| Experimental PBOHB | Experimental | Drug: Pilocarpine Hydrochloride, Drug: Brimonidine TartratePilocarpine, brimonidine, Oxymetazoline combined with Hyaluronic Acid and Bromfenac combined in an ophthalmic solution to be randomly instilled in one eye. |
| Pilocarpine 5 mgs | Active comparator | Drug: Compound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, BromfenacPilocarpine was instilled in the other oye. |
| Brimonidine 0.5 mgs | Active comparator | Drug: Compound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, BromfenacBrimonidine 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 |
|---|---|---|
| Compound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, BromfenacAlso: PBOHBPBOHB to improve uncorrected near vision in healthy presbyopic patients | Drug | Brimonidine 0.5 mgs, Pilocarpine 5 mgs |
| Pilocarpine HydrochlorideAlso: PilApply in the fellow eye | Drug | Experimental PBOHB |
| Brimonidine TartrateAlso: BrimonidineApply in the fellow eye | Drug | Experimental PBOHB |
Primary outcome
Number of eyes improving 3 lines or more near visual acuity
Time frame: 1 hour
Eyes instilled with PBOHB
Eyes improving 3 lines or more near visual acuity
Time frame: 1 hour
Eyes instilled with Pilocarpine
Eyes improving 3 lines or more near VA
Time frame: 1 hour
Eyes instilled with Brimonidine
Results and safety
Results are not available in the source record.
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, MD 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 testing Compound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac, Pilocarpine Hydrochloride and Brimonidine Tartrate in people with 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cesar Alejandro S Galeana, MD (5541851511, optallvision@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of eyes improving 3 lines or more near visual acuity (time frame: 1 hour). The study lists 3 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.