A Phase 2 interventional study of BRIMOCHOL PF eye drops; CARBACHOL PF eye drops; Brimonidine eye drops; Placebo in Presbyopia, sponsored by Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.. Recruiting at 1 site in China. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-04-29.
Sponsored by Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. (formerly part of Lee's Pharmaceutical Limited) · Phase 2, Interventional, and Treatment
A multicenter, randomized, double-Blind, crossover, placebo-controlled Phase II clinical Study to evaluate the efficacy and safety of BRIMOCHOL PF and CARBACHOL PF in the treatment of Chinese patients with presbyopia.
119 subjects were planned to be enrolled in this study and randomly assigned in equal proportions into 7 treatment sequences. Each subject will receive a total of 7 treatments, each treatment period will be 1 day, and two adjacent visits during the treatment period need to be eluted for at least 3 days。
The study period included the screening period (Day 14\~Day 1) with 1 visit and the treatment period (Day 0\~Day 30) with 7 visits. There were a total of 8 visits in this study, with a duration of 32 to 45 days.
336 studies on the registry are indexed under Presbyopia; 35 are open to participants now.
This study's planned enrollment of 119 is above the median of 61 across 276 interventional studies indexed under Presbyopia.
Browse Presbyopia studies →Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. is the lead sponsor of 17 studies on the registry; 4 are open to participants now.
First submitted after Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. left Lee's Pharmaceutical Limited.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
At least one eye meeting the following at both Visit 1 and Visit 2:
Exclusion Criteria:
BRIMOCHOL PF eye drops and placebo eye drops given once respectively in visit 2; CARBACHOL PF eye drops and placebo eye drops given once respectively in visit 3; Brimonidine eye drops and placebo eye drops given once respectively in visit 4; BRIMOCHOL PF eye drops given twice in visit 5; CARBACHOL PF eye drops given twice in visit 6; Brimonidine eye drops given twice in visit 7; Placebo eye drops given twice in visit 8.
Drug: BRIMOCHOL PF eye drops; CARBACHOL PF eye drops; Brimonidine eye drops; Placebo
Placebo eye drops given twice in visit 2; BRIMOCHOL PF eye drops and placebo eye drops given once respectively in visit 3; CARBACHOL PF eye drops and placebo eye drops given once respectively in visit 4; Brimonidine eye drops and placebo eye drops given once respectively in visit 5; BRIMOCHOL PF eye drops given twice in visit 6; CARBACHOL PF eye drops given twice in visit 7; Brimonidine eye drops given twice in visit8.
Drug: BRIMOCHOL PF eye drops; CARBACHOL PF eye drops; Brimonidine eye drops; Placebo
Brimonidine eye drops given twice in visit 2; Placebo eye drops given twice in visit 3; BRIMOCHOL PF eye drops and placebo eye drops given once respectively in visit 4; CARBACHOL PF eye drops and placebo eye drops given once respectively in visit 5; Brimonidine eye drops and placebo eye drops given once respectively in visit 6; BRIMOCHOL PF eye drops given twice in visit 7; CARBACHOL PF eye drops given twice in visit 8.
Drug: BRIMOCHOL PF eye drops; CARBACHOL PF eye drops; Brimonidine eye drops; Placebo
CARBACHOL PF eye drops given twice in visit 2; Brimonidine eye drops given twice in visit 3; Placebo eye drops given twice in visit 4; BRIMOCHOL PF eye drops and placebo eye drops given once respectively in visit 5; CARBACHOL PF eye drops and placebo eye drops given once respectively in visit 6; Brimonidine eye drops and placebo eye drops given once respectively in visit 7; BRIMOCHOL PF eye drops given twice in visit 8.
Drug: BRIMOCHOL PF eye drops; CARBACHOL PF eye drops; Brimonidine eye drops; Placebo
BRIMOCHOL PF eye drops given twice in visit 2; CARBACHOL PF eye drops given twice in visit 3; Brimonidine eye drops given twice in visit 4; Placebo eye drops given twice in visit 5; BRIMOCHOL PF eye drops and placebo eye drops given once respectively in visit 6; CARBACHOL PF eye drops and placebo eye drops given once respectively in visit 7; Brimonidine eye drops and placebo eye drops given once respectively in visit 8.
Drug: BRIMOCHOL PF eye drops; CARBACHOL PF eye drops; Brimonidine eye drops; Placebo
Brimonidine eye drops and placebo eye drops given once respectively in visit 2; BRIMOCHOL PF eye drops given twice in visit 3; CARBACHOL PF eye drops given twice in visit 4; Brimonidine eye drops given twice in visit 5; Placebo eye drops given twice in visit 6; BRIMOCHOL PF eye drops and placebo eye drops given once respectively in visit 7; CARBACHOL PF eye drops and placebo eye drops given once respectively in visit 8.
Drug: BRIMOCHOL PF eye drops; CARBACHOL PF eye drops; Brimonidine eye drops; Placebo
CARBACHOL PF eye drops and placebo eye drops given once respectively in visit 2; Brimonidine eye drops and placebo eye drops given once respectively in visit 3; BRIMOCHOL PF eye drops given twice in visit 4; CARBACHOL PF eye drops given twice in visit 5; Brimonidine eye drops given twice in visit 6; Placebo eye drops given twice in visit 7; BRIMOCHOL PF eye drops and placebo eye drops given once respectively in visit 8.
Drug: BRIMOCHOL PF eye drops; CARBACHOL PF eye drops; Brimonidine eye drops; Placebo
BRIMOCHOL PF eye drops, CARBACHOL PF eye drops, Brimonidine eye drops and Placebo were administered in 7 treatment sequences in various combinations and doses
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
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.
Time frame: 15minutes, 1hour, 2hour, 4hour15minutes, 6hour, and 8hour after administration
Changes in MCNVA(monocular corrected near visual acuity) ETDRS letters from baseline in the study eyes 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.
Time frame: 15minutes, 1hour, 2hour, 4hour15minutes, 6hour, and 8hour after administration
Changes in MCNVA(monocular corrected near visual acuity) ETDRS letters from baseline in the study eyes 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).
Time frame: 15 minutes to 8 hours after administration
Changes in MCNVA(monocular corrected near visual acuity) ETDRS letters from baseline in the study eyes 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).
Time frame: 15 minutes to 8 hours after administration
Changes in BCNVA (Binocular Corrected Near Visual Acuity) ETDRS letters and BCDVA (Binocular Corrected Distance Visual Acuity) ETDRS letters from baseline 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).
Time frame: 15minutes, 1hour, 2hour, 4hour15minutes, 6hour, and 8hour after administration
Changes in pupil diameter from baseline 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.
Time frame: 15minutes, 1hour, 2hour, 4hour15minutes, 6hour, and 8hour after administration
Plan to share: No
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Started Mar 2025 (actual). Primary completion is estimated for Sep 2025, 6 months after the start.
Of 13 phase 2 interventional studies under Presbyopia, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 8. This study's planned 6 months is close to that.
How these figures are worked out, and which studies are left out of them.
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