New eye drop combo shows promise for reading without glasses
NCT ID NCT04675151
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a combination of two eye drops (Nyxol and pilocarpine) can help people with presbyopia—age-related difficulty seeing up close—read better without glasses. About 150 adults aged 40 to 64 took part. The main goal was to see how many people could read 15 or more extra letters on an eye chart one hour after using the drops, compared to their starting vision.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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150 people
The number who actually took part.
- Started
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Feb 2021
- Finished
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Jun 2021
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 64 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Males or females ≥ 40 and ≤ 64years of age. 2. BCDVA of 0.0 LogMAR(20/20 Snellen equivalent) or better in each eye under photopic conditions. 3. DCNVA of 0.4 LogMAR (20/50 Snellen equivalent) or worse under photopic conditions in each eye and binocularly. 4. Subjects who depend on reading glasses or bifocals in which their binocular best-corrected near VA is 0.1 LogMAR (20/25 Snellen equivalent) or better. Exclusion Criteria: Ophthalmic (in either eye): 1. Use of any topical prescription or OTC ophthalmic medications of any kind within 7 days of Screening until study completion. 2. Use of any over-the-counter (OTC) artificial tears (preserved or unpreserved) at least once per day within 7 days of Screening until study completion. 3. Current use of any topical ophthalmic therapy for dry eye. 4. Tear break-up time of \< 5 seconds or corneal fluorescein staining. 5. Clinically significant ocular disease that might interfere with the study as deemed by the Investigator. 6. Recent or current evidence of ocular infection or inflammation in either eye. 7. Any history of herpes simplex or herpes zoster keratitis. 8. History of diabetic retinopathy or diabetic macular edema. 9. Known allergy, hypersensitivity, or contraindication to any component of the phentolamine, pilocarpine, or vehicle formulations. 10. History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal. 11. Ocular trauma, ocular surgery, ocular laser treatment within the 6 months prior to Screening. Any subject with multifocal intraocular lenses are excluded. 12. History of any traumatic (surgical or nonsurgical) or non traumatic condition affecting the pupil or iris. 13. Unwilling or unable to discontinue use of contact lenses. 14. Conjunctival hyperemia ≥ grade 2 on the CCLRU 4-point scale. Systemic: 15. Known hypersensitivity or contraindication to alpha- and/or beta adrenoceptor antagonists. 16. Known hypersensitivity or contraindication to any systemic cholinergic parasympathomimetic agents. 17. Clinically significant systemic disease that might interfere with the study as deemed by the Investigator. 18. Participation in any investigational study within 30 days prior to Screening. 19. Females of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. 20. Resting HR outside the specified range of 50 to 110 beats per minute. 21. Hypertension with resting diastolic BP \> 105 mmHg or systolic BP \> 160 mmHg.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Clinical Site 1
Memphis, Tennessee, 38119, United States
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Clinical Site 10
Roswell, Georgia, 30041, United States
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Clinical Site 11
Maitland, Florida, 32751, United States
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Clinical Site 12
Laguna Hills, California, 92653, United States
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Clinical Site 13
Crystal River, Florida, 34461, United States
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Clinical Site 14
Fargo, North Dakota, 58103, United States
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Clinical Site 15
Powell, Ohio, 43065, United States
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Clinical Site 16
Poughkeepsie, New York, 12603, United States
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Clinical Site 18
St Louis, Missouri, 63101, United States
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Clinical Site 2
Athens, Ohio, 45701, United States
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Clinical Site 3
Pittsburg, Kansas, 66762, United States
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Clinical Site 4
Warwick, Rhode Island, 02888, United States
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Clinical Site 5
Longwood, Florida, 32779, United States
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Clinical Site 6
Newport Beach, California, 92663, United States
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Clinical Site 7
Cleveland, Ohio, 44115, United States
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Clinical Site 8
Sarasota, Florida, 34239, United States
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Clinical Site 9
Cincinnati, Ohio, 45242, United States
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Other studies related to the condition(s) this trial covers.
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