Safety and Efficacy of Ophthalmic Phentolamine Mesylate to Reverse Pharmacologically Induced Mydriasis
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|ClinicalTrials.gov Identifier: NCT04024891|
Recruitment Status : Completed
First Posted : July 18, 2019
Last Update Posted : October 14, 2019
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
|Condition or disease||Intervention/treatment||Phase|
|Mydriasis Dilation||Drug: Phentolamine Mesylate Ophthalmic Solution 1% Other: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||August 13, 2019|
|Actual Primary Completion Date :||September 17, 2019|
|Actual Study Completion Date :||September 17, 2019|
Experimental: Phentolamine Mesylate Ophthalmic Solution 1%
1 drop in each eye, 1 hour post medically-induced mydriasis
Drug: Phentolamine Mesylate Ophthalmic Solution 1%
1% phentolamine mesylate ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
Placebo Comparator: Phentolamine Mesylate Ophthalmic Solution Vehicle
1 drop in each eye, 1 hour post medically-induced mydriasis
Other: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)
Topical Sterile Ophthalmic Solution
- 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.
- Pupil Diameter (Change from Max) [ Time Frame: 30 min, 1 hours, 4 hours, 6 hours ]Change in pharmacologically-induced mydriatic (maximum) pupil diameter at remaining timepoints (30 min, 1 hours, 4 hours, 6 hours)
- Accommodation Measured by the Near Point Rule (Diopters) (Change from Baseline) [ Time Frame: 0 min, 30 min, 1 hour, 2 hours, 4 hours, 6 hours ]
Change from baseline (-1 hour) in accommodation at each timepoint (0 min, 30 min, 1 hour, 2 hours, 4 hours, 6 hours)
Worsening of accommodation is defined as an amplitude decrease of greater than 1 diopter compared to baseline
- 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 min, 30 min, 1 hour, 2 hours, 4 hours, 6 hours ]Change from baseline (-1 hour) in BCDVA at each timepoint (0 min, 30 min, 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 min, 30 min, 1 hour, 2 hours, 4 hours, 6 hours ]Change from baseline (-1 hour) in DCNVA at each timepoint (0 min, 30 min, 1 hour, 2 hours, 4 hours, 6 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) (Change from Baseline) [ Time Frame: 0 min, 30 min, 1 hour, 2 hours, 4 hours, 6 hours ]Change from baseline (-1 hour) in conjunctival hyperemia at each timepoint (0 min, 30 min, 1 hour, 2 hours, 4 hours, 6 hours), for study eye and non-study eye; in all subjects, in subjects taking Lumify®, and in subjects not taking Lumify®
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04024891
|United States, Kansas|
|Kannar Eye Care|
|Pittsburg, Kansas, United States, 66762|
|United States, Kentucky|
|Kentucky Eye Institute|
|Lexington, Kentucky, United States, 40517|
|United States, Ohio|
|Athens Eye Care|
|Athens, Ohio, United States, 45701|
|United States, Rhode Island|
|West Bay Eye Associates|
|Warwick, Rhode Island, United States, 02888|