All > North Dakota > Missouri

Nyxol + low dose pilocarpine for Presbyopia

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Northridge, CA, Northridge, CAPresbyopiaLow dose pilocarpine vehicle - Other
Eligibility
40 - 64
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test a new eye treatment to improve near vision in people with presbyopia.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
MIJ821 - low dose
1
0.1% STN1013600 ophthalmic solution
1
AGN-241622

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Visit 2 at 0.5, 1, 3, 5, 8 and 12 hours post-Nyxol/placebo

Hour 8
Percent of subjects with ≥ 15 letters improvement in photopic binocular DCNVA and with < 5 letters of loss in photopic binocular BCDVA in Nyxol-treated subjects
Hour 12
Percentage of subjects with ≥ 5, ≥ 10, and ≥ 15 letters of improvement in photopic binocular distance-corrected intermediate visual acuity (DCIVA) from Baseline in Nyxol-treated subjects
Hour 12
Percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA and with < 5 letters of loss in photopic binocular BCDVA in Nyxol-treated subjects
Hour 5
Percent of subjects with ≥ 15 letters improvement in photopic binocular DCNVA and with < 5 letters of loss in photopic binocular BCDVA in LDP+Nyxol-treated subjects
Hour 8
Percentage of subjects with ≥ 5, ≥ 10, and ≥ 15 letters of improvement in photopic binocular DCIVA from Baseline in LDP+Nyxol-treated subjects
Hour 8
Percent of subjects with ≥ 15 letters improvement in photopic binocular DCNVA and with < 5 letters of loss in in photopic binocular BCDVA in LDP+Nyxol-treated subjects

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

2
MIJ821 - low dose
2
0.1% STN1013600 ophthalmic solution
1
AGN-241622

Trial Design

4 Treatment Groups

Nyxol + low dose pilocarpine
1 of 4
Nyxol + low dose pilocarpine vehicle
1 of 4
Placebo + low dose pilocarpine
1 of 4
Placebo + low dose pilocarpine vehicle
1 of 4

Experimental Treatment

Non-Treatment Group

320 Total Participants · 4 Treatment Groups

Primary Treatment: Nyxol + low dose pilocarpine · Has Placebo Group · Phase 3

Nyxol + low dose pilocarpineExperimental Group · 2 Interventions: Phentolamine Opthalmic Solution 0.75%, Low dose pilocarpine · Intervention Types: Drug, Drug
Nyxol + low dose pilocarpine vehicleExperimental Group · 2 Interventions: Low dose pilocarpine vehicle, Phentolamine Opthalmic Solution 0.75% · Intervention Types: Other, Drug
Placebo + low dose pilocarpineExperimental Group · 2 Interventions: Placebo, Low dose pilocarpine · Intervention Types: Other, Drug
Placebo + low dose pilocarpine vehiclePlaceboComparator Group · 2 Interventions: Low dose pilocarpine vehicle, Placebo · Intervention Types: Other, Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: visit 2 at 0.5, 1, 3, 5, 8 and 12 hours post-nyxol/placebo

Who is running the clinical trial?

Ocuphire Pharma, Inc.Lead Sponsor
10 Previous Clinical Trials
1,129 Total Patients Enrolled
1 Trials studying Presbyopia
150 Patients Enrolled for Presbyopia

Eligibility Criteria

Age 40 - 64 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

Can you elucidate the dangers of administering Nyxol and low dose pilocarpine to patients?

"With prior clinical data attesting to its safety, Nyxol + low dose pilocarpine was evaluated and assigned a score of 3." - Anonymous Online Contributor

Unverified Answer

Are any vacancies still available for enrollment in this research?

"Clinicaltrials.gov reports that the recruitment process for this medical study is still ongoing; it was initially posted on December 22nd 2022 with its most recent edit taking place on February 24th 2023." - Anonymous Online Contributor

Unverified Answer

Does this research program accept elderly participants?

"This medical trial has a 40-year old minimum age limit and an upper threshold of 64 years." - Anonymous Online Contributor

Unverified Answer

How many participants are eligible to join this clinical research program?

"Ocuphire Pharma, Inc. will be conducting the trial at two sites: Phoenix in Arizona and Azusa in California. In order to successfully complete this study, 320 patients meeting all inclusion criteria must participate." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top