Near VisionEarly Phase 1NCT05564832
Pharmacological Treatment of Presbyopia
A Early Phase 1 study testing Pilocarpine 1.25% Eye drop in people with Near Vision, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
In this clinical trial, a total of 75 presbyopic patients in the age range of 40 to 60 years old will be participated. The right eyes of 45 patients will be treated by Biocarpine® and they will be considered as the case group, their left eyes will be defined as the controls. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Near Vision
- What is being tested?
- Pilocarpine 1.25% Eye drop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteIran
- Study dates
- 1 Aug 2022to 1 Jan 2023
- Phase
- Early 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
- Subjects with the best corrected visual acuity (BCVA) better than 0.3LogMAR
- Patients with the symptom of blurred vision at near distance
Who cannot join
- Patients with amblyopia, cataract, corneal opacity, glaucoma, intraocular surgery, eye troma, congenital pupil anomalies and those with the history of headache and allergy to the eye drop will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Hamideh Sabbaghi
Tehran
Hamideh Sabbaghi, PhD, 989120285930, sabbaghi.opt@gmail.com
About this study
Official title: Pharmacological Treatment of Presbyopia by Pilocarpine 1.25% Eye Drops
In this clinical trial, a total of 75 presbyopic patients in the age range of 40 to 60 years old will be participated. The right eyes of 45 patients will be treated by Biocarpine® and they will be considered as the case group, their left eyes will be defined as the controls. In another case group, the right eyes of 30 patients will received Vuity® eye drops and their left eyes will be considered as controls.
- Conditions
- Near Vision
- Being tested
- Pilocarpine 1.25% Eye drop
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilocarpine 1.25% Eye dropDrug
One millimeter of pilocarpine eye drop (Bakhtarbiochemistry Company, Iran) contains pilocarpine hydrochloride 1.25% (12.5 mg) as an active ingredient, equivalent to 1.06% (10.6 mg) pilocarpine free-base. The medication preservative is 0.0075% benzalkonium chloride. Inactive ingredients in the ophthalmic are boric acid, sodium citrate dihydrate, sodium chloride, purified water. Another pilocarpine eye drop was Vuity® (1.25% pilocarpine; Allergan company) contains the active intergradients of pilocarpine hydrochloride 1.25% (12.5 mg/mL), equivalent to 1.06% (10.6 mg/mL) pilocarpine free-base and the preservative agents was 0.0075% benzalkonium chloride.
| Study group | Role | What they receive |
|---|---|---|
| Pilocarpine Therapy | Experimental | The right eyes of 45 patients will be treated by Biocarpine® and Vuity® eye drops. They will be considered as the case group, Receives: Drug: Pilocarpine 1.25% Eye drop |
| Without Pilocarpine Therapy | No intervention | The left eyes of the patients will be defined as the controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of near vision after one hour following pilocarpine eye drop
The near vision will be measured based on the LogMAR vision at a distance of 33cm before and one hour after instillation of 1.25% pilocarpine eye drop.
Measured: baseline to one hour after pilocarpine insillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start1 Aug 2022
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Near VisionStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamideh Sabbaghi, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05564832
- Sponsor's protocol ID
- IR.SBMU.ORC.REC.1401.005
- Status last verified
- Oct 2022
- First submitted
- 17 Sep 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological Treatment of Presbyopia by Pilocarpine 1.25% Eye Drops
- ClinicalTrials.gov ID
- NCT05564832
- Acronym / sponsor ID
- IR.SBMU.ORC.REC.1401.005
- Conditions
- Near Vision
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 4 Oct 2022 (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.
In this clinical trial, a total of 75 presbyopic patients in the age range of 40 to 60 years old will be participated. The right eyes of 45 patients will be treated by Biocarpine® and they will be considered as the case group, their left eyes will be defined as the controls. In another case group, the right eyes of 30 patients will received Vuity® eye drops and their left eyes will be considered as controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilocarpine Therapy | Experimental | Drug: Pilocarpine 1.25% Eye dropThe right eyes of 45 patients will be treated by Biocarpine® and Vuity® eye drops. They will be considered as the case group, |
| Without Pilocarpine Therapy | No intervention | –The left eyes of the patients will be defined as the controls. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects with the best corrected visual acuity (BCVA) better than 0.3LogMAR
- Patients with the symptom of blurred vision at near distance
Key exclusion criteria (1 listed)
- Patients with amblyopia, cataract, corneal opacity, glaucoma, intraocular surgery, eye troma, congenital pupil anomalies and those with the history of headache and allergy to the eye drop will be excluded from the study.
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 |
|---|---|---|
| Pilocarpine 1.25% Eye dropOne millimeter of pilocarpine eye drop (Bakhtarbiochemistry Company, Iran) contains pilocarpine hydrochloride 1.25% (12.5 mg) as an active ingredient, equivalent to 1.06% (10.6 mg) pilocarpine free-base. The medication preservative is 0.0075% benzalkonium chloride. Inactive ingredients in the ophthalmic are boric acid, sodium citrate dihydrate, sodium chloride, purified water. Another pilocarpine eye drop was Vuity® (1.25% pilocarpine; Allergan company) contains the active intergradients of pilocarpine hydrochloride 1.25% (12.5 mg/mL), equivalent to 1.06% (10.6 mg/mL) pilocarpine free-base and the preservative agents was 0.0075% benzalkonium chloride. | Drug | Pilocarpine Therapy |
Primary outcome
The changes of near vision after one hour following pilocarpine eye drop
Time frame: baseline to one hour after pilocarpine insillation
The near vision will be measured based on the LogMAR vision at a distance of 33cm before and one hour after instillation of 1.25% pilocarpine eye drop.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pilocarpine 1.25% Eye drop in people with Near Vision, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 2 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: status not confirmed, as of the sponsor's last update on 4 Oct 2022. 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 Iran. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes of near vision after one hour following pilocarpine eye drop (time frame: baseline to one hour after pilocarpine insillation). 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 4 Oct 2022.