The Safety and Efficacy of SYD-101 in Children With Myopia

Phase 3

Active, not recruiting

Conditions: Near-sightedness
Near Sightedness
Nearsightedness

Interventions: Drug: SYD-101 Dose 1
Drug: SYD-101 Dose 2
Drug: Vehicle

Registration Number: NCT03918915

Lead Sponsor: Sydnexis, Inc.

Brief Summary: Myopia, or nearsightedness, is the most common eye disorder, often affecting more than 40% of adults in Europe, Asia and the USA. Severe myopia is associated with an increased risk of developing other eye conditions such as glucoma, cataracts and retinal detachment, which may lead to blindness. Early treatment of myopia in children could help slow the condition and minimize the risk of complications later in life. This study investigates the use of SYD-101, an eye solution, in slowing-down the progression of myopia in children.

Detailed Description: This will be a 5-arm, multicentered, randomized, double-masked, vehicle-controlled study conducted in 2 parts.

Part 1 is the primary treatment period of 3 years, during which participants will receive 1 of 3 masked medications.

Part 2 is the randomized withdrawal period of 1 year, during which participants originally receiving Vehicle will receive SYD-101, and participants originally receiving SYD-101 will receive either Vehicle or SYD-101.

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 852

Inclusion Criteria

Myopia of 0.5 D (diopters) to 6.00 D (inclusive) in both eyes.
Astigmatism ≤1.50 D in both eyes.
Anisometropia ≤1.00 D in both eyes.
If myopia is ≥0.75 D, participant must be wearing single vision eyeglasses or soft, daily-wear, single-vision contact lenses that meet study investigator's criteria.
BCVA (best-corrected visual acuity) Snellen equivalent of 20/32 or better.

Exclusion Criteria

Participants with a history or current evidence of a medical condition predisposing them to degenerative myopia (e.g. Marfan syndrome, Stickler syndrome), or a condition that may affect visual function or development (e.g. diabetes mellitus, chromosome anomaly).
Current use of a monoamine oxidase inhibitor.
Evidence of any ocular inflammation or infection in either eye, including blepharitis, conjunctivitis, keratitis, and scleritis.
Past, present or future plans to use orthokeratology (orthoK), rigid gas-permeable, bifocal, progressive-addition, multi-focal, or other lenses to reduce myopia progression; or the use of atropine, pirenzepine or other anti-muscarinic agent for myopia.
History or evidence of ocular surgery or planned future ocular surgery in either eye.

Other protocol-defined inclusion/exclusion criteria could apply.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 1: SYD-101 Dose 1; Part 2: Vehicle	SYD-101 Dose 1	1 drop in each eye at bedtime.
Part 1: SYD-101 Dose 2; Part 2: SYD-101 Dose 2	SYD-101 Dose 2	1 drop in each eye at bedtime.
Part 1: Vehicle; Part 2: SYD-101 Dose 2	SYD-101 Dose 2	1 drop in each eye at bedtime.
Part 1: Vehicle; Part 2: SYD-101 Dose 2	Vehicle	1 drop in each eye at bedtime.
Part 1: SYD-101 Dose 1; Part 2: Vehicle	Vehicle	1 drop in each eye at bedtime.
Part 1: SYD-101 Dose 1; Part 2: SYD-101 Dose 1	SYD-101 Dose 1	1 drop in each eye at bedtime.
Part 1: SYD-101 Dose 2; Part 2: Vehicle	SYD-101 Dose 2	1 drop in each eye at bedtime.
Part 1: SYD-101 Dose 2; Part 2: Vehicle	Vehicle	1 drop in each eye at bedtime.

Primary Outcome Measures

Name	Time	Method
Myopic progression >0.75 D (diopters)	Month 36	Proportion of participants with confirmed myopic progression \>0.75 D (diopters), based on SE (spherical equivalent) as measured by cycloplegic autorefraction

Secondary Outcome Measures

Name	Time	Method
Proportion of participants with annual myopia progression rate > 0.50 D/year	Month 36	Mean annual progression rate of myopia
Time to progression of myopia >0.75 D (diopters)	Up to 36 months (from date of randomization until date myopia progresses >0.75 D)	Progression of myopia measured as Spherical Equivalent (SE) via cycloplegic autorefraction.
Proportion of participants with annual myopia progression rate <=0.50 D/year	Through Month 36	Mean annual progression rate of myopia
Mean annual myopic progression	Month 36	Mean annual progression rate of myopia measured in diopters: Spherical Equivalent (SE) as measured by cycloplegic autorefraction.
Proportion of participants with annual myopia progression rate <=0.25 D/year	Through Month 36	Mean annual progression rate of myopia
Mean change from baseline in axial length	Baseline to Month 36	Measured by cycloplegic biometry

Trial Locations

Locations (47): Site 122
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Fort Lauderdale, Florida, United States
Site 109
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Jupiter, Florida, United States
Site 119
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Sweetwater, Florida, United States
Site 120
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Tamarac, Florida, United States
Site 115
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The Woodlands, Texas, United States
Site 149
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Ogden, Utah, United States
Site 140
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Ogden, Utah, United States
Site 113
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Virginia Beach, Virginia, United States
Site 205
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Vienna, Austria
Site 202
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Bratislava, Slovakia
Site 201
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Trebišov, Slovakia
Site 200
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Trenčín, Slovakia
Site 203
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Linz, Oberosterreich, Austria
Site 204
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Graz, Styria, Austria
Site 150
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Waterbury, Connecticut, United States
Site 143
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Irwindale, California, United States
Site 144
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Pasadena, California, United States
Site 131
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Munster, Indiana, United States
Site 148
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San Diego, California, United States
Site 104
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San Diego, California, United States
Site 110
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Santa Barbara, California, United States
Site 133
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Sunnyvale, California, United States
Site 130
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Colorado Springs, Colorado, United States
Site 100
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Fort Collins, Colorado, United States
Site 102
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Danbury, Connecticut, United States
Site 124
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Marietta, Georgia, United States
Site 116
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Chicago, Illinois, United States
Site 106
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Wilmette, Illinois, United States
Site 135
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Indianapolis, Indiana, United States
Site 137
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Pittsburg, Kansas, United States
Site 138
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Bangor, Maine, United States
Site 123
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Boston, Massachusetts, United States
Site 114
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Washington, Missouri, United States
Site 132
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Henderson, Nevada, United States
Site 139
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Albuquerque, New Mexico, United States
Site 127
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Buffalo, New York, United States
Site 117
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Chapel Hill, North Carolina, United States
Site 121
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Raleigh, North Carolina, United States
Site 105
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Fargo, North Dakota, United States
Site 101
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San Antonio, Texas, United States
Site 111
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Medford, Oregon, United States
Site 147
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Tigard, Oregon, United States
Sie 136
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Bala-Cynwyd, Pennsylvania, United States
Site 128
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Cranberry Township, Pennsylvania, United States
Site 108
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Charleston, South Carolina, United States
Site 126
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Lakeway, Texas, United States
Site 142
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San Antonio, Texas, United States