MydriasisPhase 2NCT04024891
Safety and Efficacy of Ophthalmic Phentolamine Mesylate to Reverse Pharmacologically Induced Mydriasis
A Phase 2 study testing Phentolamine Mesylate Ophthalmic Solution 1% in people with Mydriasis and Dilation, run by Opus Genetics, Inc at 4 sites in United States.
Trial summary
The objectives of this study are: To evaluate the efficacy of Nyxol (phentolamine mesylate ophthalmic solution 1%) to expedite the reversal of pharmacologic mydriasis To evaluate the safety of Nyxol To evaluate the effect of Lumify® to suppress conjunctival hyperemia (redness) potentially associated with… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- What is being tested?
- Phentolamine Mesylate Ophthalmic Solution 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 4 sitesUnited States
- Study dates
- 13 Aug 2019to 17 Sep 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or females ≥ 18 and ≤ 45 years of age with brown irides (irises) only
- Otherwise healthy and well controlled subjects
- Able to comply with all protocol mandated procedures and to attend all scheduled office visits
- Willing to give written informed consent to participate in this study
Who cannot join
- Clinically significant ocular disease as deemed by the Investigator (e.g., cataract, glaucoma, corneal edema, uveitis, severe keratoconjunctivitis sicca) that might interfere with the study
- Unwilling or unable to discontinue use of contact lenses during treatment visits
- Ocular trauma, ocular surgery or non-refractive laser treatment within the 6 months prior to screening
- Ocular medication of any kind within 30 days of screening, with the exception of a) lid scrubs (which may have been used prior to, but not after screening) or b) lubricating drops for dry eye (preservative-free artificial tears), which may be used in between the study treatment days
- Recent or current evidence of ocular infection or inflammation. Current evidence of clinically significant blepharitis, conjunctivitis, or a history of herpes simplex or herpes zoster keratitis at screening
- History of diabetic retinopathy
Show all 16Show fewer
- Closed or very narrow angles that in the Investigator's opinion are potentially occludable if the subject's pupil is dilated
- History of any traumatic (surgical or nonsurgical) or non-traumatic condition affecting the pupil or iris (e.g., irregularly shaped pupil, neurogenic pupil disorder, iris atrophy, iridotomy)
- Known allergy or contraindication to any component of the mydriatic agents or the vehicle formulation
- Known hypersensitivity or contraindication to α- and/or β-adrenoceptor antagonists (e.g., chronic obstructive pulmonary disease or bronchial asthma; abnormally low blood pressure (BP) or heart rate (HR); second- or third-degree heart blockage or Congestive Heart Failure (CHF); severe diabetes)
- Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, cancer, hepatic, renal, endocrine or cardiovascular disorders) that might interfere with the study
- Initiation of treatment with or any changes to the current dosage, drug or regimen of any topical or systemic adrenergic or cholinergic drugs up to 7 days prior to screening, or during the study
- Participation in any investigational study within 30 days prior to screening
- Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. Acceptable methods include the use of at least one of the following: intrauterine device (IUD), hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence. An adult woman is considered to be of childbearing potential unless she is 1 year postmenopausal or 3 months post-surgical sterilization. All females of childbearing potential must have a negative urine pregnancy test result at Visit 1/Screening and Visit 2 examinations and must intend to not become pregnant during the study
- Resting heart rate (HR) outside the normal range (50-110 beats per minute) at the Screening Visit. HR may be repeated only once if outside the normal range following at least a 5-minute rest period in the sitting position
- Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg at the Screening Visit. BP may be repeated only once if outside the specified range following at least a 5-minute rest period in the sitting position
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Athens Eye Care
Athens, Ohio, 45701
Kentucky Eye Institute
Lexington, Kentucky, 40517
Kannar Eye Care
Pittsburg, Kansas, 66762
West Bay Eye Associates
Warwick, Rhode Island, 02888
About this study
Official title: Randomized, Cross-Over, Double-Masked, Placebo-Controlled Study of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution to Reverse Pharmacologically Induced Mydriasis in Normal Healthy Subjects
The objectives of this study are:
- To evaluate the efficacy of Nyxol (phentolamine mesylate ophthalmic solution 1%) to expedite the reversal of pharmacologic mydriasis
- To evaluate the safety of Nyxol
- To evaluate the effect of Lumify® to suppress conjunctival hyperemia (redness) potentially associated with administration of Nyxol
Read the detailed description
Randomized, 2-arm cross-over, double-masked Phase 2b study in approximately 32 healthy subjects, evaluating safety and efficacy of Nyxol in subjects with pharmacologically induced mydriasis.
At the first visit subjects will be screened for study eligibility.
After screening, eligible subjects will be randomized 1:1 to one of the two treatment sequences:
Treatment sequence 1: Placebo (Visit 1), Nyxol (Visit 2).
Treatment sequence 2: Nyxol (Visit 1), Placebo (Visit 2).
Randomization will be stratified by mydriatic agent (2.5% phenylephrine or 1% tropicamide). Approximately one half of the randomized subjects will receive 2.5% phenylephrine and one half will receive 1% tropicamide. Subjects will receive their mydriatic agent 1 hour before treatment. Each subject will receive the same mydriatic agent throughout the study.
At each visit, pupil diameter (PD), accommodation, near and distance visual acuity (VA) and redness in each eye will be measured before (-1 hour/baseline) and 1 hour after (maximum/0 minutes) the mydriatic agent instillation in each eye (i.e., right before the study treatment is administered), and at 30 minutes, 1 hour, 2 hours, 4 hours and 6 hours after treatment dosing.
As needed, two hours post treatment, subjects may request the administration of Lumify® in the non-study eye.
- Being tested
- Phentolamine Mesylate Ophthalmic Solution 1%, Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)
- Keywords
- Nyxol, Pharmacologically Induced Mydriasis, Dilation
- Medical subject headings
- Mydriasis, Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phentolamine Mesylate Ophthalmic Solution 1%Drug
Also called Nyxol®, Nyxol
1% phentolamine mesylate ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)Other
Topical Sterile Ophthalmic Solution
| Study group | Role | What they receive |
|---|---|---|
| Phentolamine Mesylate Ophthalmic Solution 1% | Experimental | 1 drop in each eye, 1 hour post medically-induced mydriasis Receives: Drug: Phentolamine Mesylate Ophthalmic Solution 1% |
| Phentolamine Mesylate Ophthalmic Solution Vehicle | Placebo comparator | 1 drop in each eye, 1 hour post medically-induced mydriasis Receives: Other: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupil Diameter (Change From Max)
Change in pharmacologically-induced mydriatic (maximum) pupil diameter at 2 hours post-treatment in the study eye.
Measured: 2 hours
Secondary outcomes (6)
Pupil Diameter (Change From Max)
Change in pharmacologically-induced mydriatic (maximum) pupil diameter at remaining timepoints (30 min, 1 hours, 4 hours, 6 hours)
Measured: 30 min, 1 hours, 4 hours, 6 hours
Pupil Diameter Return to Baseline
Percent of Subjects Achieving Pupil Diameter No More Than 0.5 mm Above Baseline by Time Point with either phenylephrine or tropicamide
Measured: 0 min, 1 hour, 2 hours, 4 hours, 6 hours
Accommodation Measured by the Near Point Rule (Diopters) (Change From Baseline), Percent With Unchanged Accommodation
Change from baseline (-1 hour) in accommodation at each time point (0 min, 2 hours, 4 hours) with Tropicamide and Phenylephrine
Worsening of accommodation is defined as an amplitude decrease of greater than 1 diopter compared to baseline
Measured: 0 min, 2 hours, 4 hours
Conjunctival Hyperemia (Eye Redness) Assessed Visually With the Brien Holden Vision Institute (Formerly Corneal and Contact Lens Research Unit, or CCLRU) Bulbar Redness Scale (0-3)
Conjunctival hyperemia at each timepoint (0 min, 30 min, 1 hour, 2 hours, 4 hours, 6 hours), for study eye; in all subjects. Scale 0-3 (None, Mild, Moderate, Severe)
Measured: 0 min, 30 min, 1 hour, 2 hours, 4 hours, 6 hours
Best Corrected Distance Visual Acuity (BCDVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Light Box Chart (Letters) at 4 Meters (Change From Baseline)
Change from baseline (-1 hour) in Best Corrected Distance Visual Acuity at each time point (0 min, 30 mins, 1 hour, 2 hours, 6 hours) in Study Eye
Measured: 0 mins, 30 mins, 1 hour, 2 hours, 4 hours, 6 hours
Distance-Corrected Near Visual Acuity (DCNVA) Measured by Standard Reading Card (Original Series Sloan Letter ETDRS Card at 16 Inches, LogMAR Units) (Change From Baseline)
Change from baseline (-1 hour) in Distance Corrected Near Visual Acuity at each time point (0 min, 30 mins, 1 hour, 2 hours, 6 hours) in Study Eye
Measured: 0 mins, 30 mins, 1 hour, 2 hours, 4 hours, 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start13 Aug 2019
- Primary completion17 Sep 2019
- Study completion17 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MydriasisStudies 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Parallel Assignment
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Opus Genetics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024891
- Sponsor's protocol ID
- OPI-NYXRM-201 (MIRA-1)
- Status last verified
- Aug 2022
- First submitted
- 11 Jul 2019
- Last updated
- 30 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karpecki PM, Foster SA, Montaquila SM, Kannarr SR, Slonim CB, Meyer AR, Sooch MP, Jaber RM, Charizanis K, Yousif JE, Klapman SA, Amin AT, McDonald MB, Horn GD, Lazar ES, Pepose JS. Phentolamine Eye Drops Reverse Pharmacologically Induced Mydriasis in a Randomized Phase 2b Trial. Optom Vis Sci. 2021 Mar 1;98(3):234-242. doi: 10.1097/OPX.0000000000001656.
PubMed 33633016
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Cross-Over, Double-Masked, Placebo-Controlled Study of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution to Reverse Pharmacologically Induced Mydriasis in Normal Healthy Subjects
- ClinicalTrials.gov ID
- NCT04024891
- Acronym / sponsor ID
- OPI-NYXRM-201 (MIRA-1)
- Keywords
- Nyxol, Pharmacologically Induced Mydriasis, Dilation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Opus Genetics, IncIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2019 (actual)
- Primary completion
- 17 Sep 2019 (actual)
- Study completion
- 17 Sep 2019 (actual)
- First posted
- 18 Jul 2019 (actual)
- Results
- Posted 15 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are:
- To evaluate the efficacy of Nyxol (phentolamine mesylate ophthalmic solution 1%) to expedite the reversal of pharmacologic mydriasis
- To evaluate the safety of Nyxol
- To evaluate the effect of Lumify® to suppress conjunctival hyperemia (redness) potentially associated with administration of Nyxol
Detailed description
Randomized, 2-arm cross-over, double-masked Phase 2b study in approximately 32 healthy subjects, evaluating safety and efficacy of Nyxol in subjects with pharmacologically induced mydriasis.
At the first visit subjects will be screened for study eligibility.
After screening, eligible subjects will be randomized 1:1 to one of the two treatment sequences:
Treatment sequence 1: Placebo (Visit 1), Nyxol (Visit 2).
Treatment sequence 2: Nyxol (Visit 1), Placebo (Visit 2).
Randomization will be stratified by mydriatic agent (2.5% phenylephrine or 1% tropicamide). Approximately one half of the randomized subjects will receive 2.5% phenylephrine and one half will receive 1% tropicamide. Subjects will receive their mydriatic agent 1 hour before treatment. Each subject will receive the same mydriatic agent throughout the study.
At each visit, pupil diameter (PD), accommodation, near and distance visual acuity (VA) and redness in each eye will be measured before (-1 hour/baseline) and 1 hour after (maximum/0 minutes) the mydriatic agent instillation in each eye (i.e., right before the study treatment is administered), and at 30 minutes, 1 hour, 2 hours, 4 hours and 6 hours after treatment dosing.
As needed, two hours post treatment, subjects may request the administration of Lumify® in the non-study eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Phentolamine Mesylate Ophthalmic Solution 1% | Experimental | Drug: Phentolamine Mesylate Ophthalmic Solution 1%1 drop in each eye, 1 hour post medically-induced mydriasis |
| Phentolamine Mesylate Ophthalmic Solution Vehicle | Placebo comparator | Other: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)1 drop in each eye, 1 hour post medically-induced mydriasis |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males or females ≥ 18 and ≤ 45 years of age with brown irides (irises) only
- Otherwise healthy and well controlled subjects
- Able to comply with all protocol mandated procedures and to attend all scheduled office visits
- Willing to give written informed consent to participate in this study
Key exclusion criteria (16 listed)
- Clinically significant ocular disease as deemed by the Investigator (e.g., cataract, glaucoma, corneal edema, uveitis, severe keratoconjunctivitis sicca) that might interfere with the study
- Unwilling or unable to discontinue use of contact lenses during treatment visits
- Ocular trauma, ocular surgery or non-refractive laser treatment within the 6 months prior to screening
- Ocular medication of any kind within 30 days of screening, with the exception of a) lid scrubs (which may have been used prior to, but not after screening) or b) lubricating drops for dry eye (preservative-free artificial tears), which may be used in between the study treatment days
- Recent or current evidence of ocular infection or inflammation. Current evidence of clinically significant blepharitis, conjunctivitis, or a history of herpes simplex or herpes zoster keratitis at screening
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 |
|---|---|---|
| Phentolamine Mesylate Ophthalmic Solution 1%Also: Nyxol®, Nyxol1% phentolamine mesylate ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist | Drug | Phentolamine Mesylate Ophthalmic Solution 1% |
| Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)Topical Sterile Ophthalmic Solution | Other | Phentolamine Mesylate Ophthalmic Solution Vehicle |
Primary outcome
Pupil Diameter (Change From Max)
Time frame: 2 hours
Change in pharmacologically-induced mydriatic (maximum) pupil diameter at 2 hours post-treatment in the study eye.
6 secondary outcomes
Pupil Diameter (Change From Max)
Time frame: 30 min, 1 hours, 4 hours, 6 hours
Pupil Diameter Return to Baseline
Time frame: 0 min, 1 hour, 2 hours, 4 hours, 6 hours
Accommodation Measured by the Near Point Rule (Diopters) (Change From Baseline), Percent With Unchanged Accommodation
Time frame: 0 min, 2 hours, 4 hours
Conjunctival Hyperemia (Eye Redness) Assessed Visually With the Brien Holden Vision Institute (Formerly Corneal and Contact Lens Research Unit, or CCLRU) Bulbar Redness Scale (0-3)
Time frame: 0 min, 30 min, 1 hour, 2 hours, 4 hours, 6 hours
Best Corrected Distance Visual Acuity (BCDVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Light Box Chart (Letters) at 4 Meters (Change From Baseline)
Time frame: 0 mins, 30 mins, 1 hour, 2 hours, 4 hours, 6 hours
Distance-Corrected Near Visual Acuity (DCNVA) Measured by Standard Reading Card (Original Series Sloan Letter ETDRS Card at 16 Inches, LogMAR Units) (Change From Baseline)
Time frame: 0 mins, 30 mins, 1 hour, 2 hours, 4 hours, 6 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33633016Karpecki PM, Foster SA, Montaquila SM, Kannarr SR, Slonim CB, Meyer AR, Sooch MP, Jaber RM, Charizanis K, Yousif JE, Klapman SA, Amin AT, McDonald MB, Horn GD, Lazar ES, Pepose JS. Phentolamine Eye Drops Reverse Pharmacologically Induced Mydriasis in a Randomized Phase 2b Trial. Optom Vis Sci. 2021 Mar 1;98(3):234-242. doi: 10.1097/OPX.0000000000001656.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Phentolamine Mesylate Ophthalmic Solution 1% in people with Mydriasis and Dilation, run by Opus Genetics, Inc at 4 sites in United States.
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 4 inclusion and 16 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: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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. Some participants in this study may receive a placebo. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pupil Diameter (Change From Max) (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04024891, which also lists 1 linked publication.
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 30 Oct 2026.