Trial · NCT06948357
Efficacy and Safety of BRIMOCHOL PF and CARBACHOL PF in Chinese Presbyopia Patients
NCT06948357, Phase 2, Recruiting, Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of BRIMOCHOL PF and CARBACHOL PF in Chinese Presbyopia Patients. Trials, record NCT06948357. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06948357
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of BRIMOCHOL PF and CARBACHOL PF in Chinese Presbyopia Patients
- NCT number
- NCT06948357
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 119 participants, estimated
- Lead sponsor
- Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
- Conditions
- Presbyopia
- Interventions
- BRIMOCHOL PF eye drops; CARBACHOL PF eye drops; Brimonidine eye drops; Placebo
- First posted
- 2025-04-29
- Last updated
- 2025-04-29
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in MCNVA(monocular corrected near visual acuity) ETDRS letters and MCDVA (monocular corrected distance visual acuity) ETDRS letters from baseline in the study eyes after administration | 15minutes, 1hour, 2hour, 4hour15minutes, 6hour, and 8hour after administration | In the mesopic condition, the proportion of subjects whose MCNVA in the study eye increased by ≥15 ETDRS letters and whose MCDVA in the study eye did not decrease by ≥5 ETDRS letters from the pre-dose baseline at 15minutes, 1hour, 2hour, 4hour15minutes, 6hour, and 8hour after dosing. |
| Secondary | Changes in MCNVA(monocular corrected near visual acuity) ETDRS letters from baseline in the study eyes after administration | 15minutes, 1hour, 2hour, 4hour15minutes, 6hour, and 8hour after administration | 1. In the mesopic conditions, the proportion of subjects whose MCNVA in the study eye increased by ≥ 10 ETDRS letters and whose MCDVA in the study eye did not decrease by ≥5 ETDRS letters from the pre-dose baseline at 15minutes, 1hour, 2hour, 4hour15minutes, 6hour, and 8hour after dosing. 2. In the mesopic conditions, the proportion of subjects whose MCNVA in the study eye increased by ≥ 15 ETDRS letters from the pre-dose baseline at 15minutes, 1hour, 2hour, 4hour15minutes, 6hour, and 8hour after dosing. 3. In the mesopic conditions, the proportion of subjects whose MCNVA in the study eye increased by ≥ 10 ETDRS letters from the pre-dose baseline at 15minutes, 1hour, 2hour, 4hour15minutes, 6hour, and 8hour after dosing. |
| Secondary | Changes in MCNVA(monocular corrected near visual acuity) ETDRS letters from baseline in the study eyes after administration | 15 minutes to 8 hours after administration | Mean ETDRS letter gain in study eye MCNVA compared to the baseline measurements under mesopic conditions across all post-dose evaluation intervals (15 minutes through 8 hours). |
| Secondary | Changes in MCNVA(monocular corrected near visual acuity) ETDRS letters from baseline in the study eyes after administration | 15 minutes to 8 hours after administration | The weighted mean of the area under the curve (AUC) for the increase in MCNVA ETDRS letter gain from baseline under mesopic conditions in the study eye across post-dose evaluation intervals (15 minutes through 8 hours). |
| Secondary | Changes in BCNVA (Binocular Corrected Near Visual Acuity) ETDRS letters and BCDVA (Binocular Corrected Distance Visual Acuity) ETDRS letters from baseline after administration | 15minutes, 1hour, 2hour, 4hour15minutes, 6hour, and 8hour after administration | 1. In the mesopic condition, the proportion of subjects whose BCNVA increased by ≥15 ETDRS letters and whose BCDVA did not decrease by ≥5 ETDRS letters from the pre-dose baseline at 15minutes, 1hour, 2hour, 4hour15minutes, 6hour, and 8hour after dosing. 2. In the mesopic condition, the proportion of subjects whose BCNVA increased by ≥10 ETDRS letters and whose BCDVA did not decrease by ≥5 ETDRS letters from the pre-dose baseline at 15minutes, 1hour, 2hour, 4hour15minutes, 6hour, and 8hour after dosing. 3. In the mesopic conditions, the proportion of subjects whose BCNVA increased by ≥ 15 ETDRS letters across all post-dose evaluation intervals (15minutes through 8hour). 4. In the mesopic conditions, the proportion of subjects whose BCNVA increased by ≥ 10 ETDRS letters across all post-dose evaluation intervals (15minutes through 8hour). |
| Secondary | Changes in pupil diameter from baseline after administration | 15minutes, 1hour, 2hour, 4hour15minutes, 6hour, and 8hour after administration | Quantitative changes in pupil diameter (measured in study eye and binocular average) from pre-dose baseline values under mesopic conditions at 15minutes, 1hour, 2hour, 4hour15minutes, 6hour, and 8hour after administration. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06948357
GET https://conductscience.org/api/trials/v1/NCT06948357/registered