Clinical trial NCT03918915: The Safety and Efficacy of SYD-101 in Children With Myopia
Official title: A Multicenter, Randomized, Double-masked, Vehicle-controlled Study to Assess the Safety and Efficacy of SYD-101 Ophthalmic Solution for the Treatment of Myopia in Children
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Nearsightedness
Near Sightedness
Near-sightedness
Keywords: Children
Myopia
Lead sponsor: Sydnexis, Inc.
Sponsor class: INDUSTRY
First posted: 2019-04-18
Enrollment: 852
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Myopic progression >0.75 D (diopters)
timeFrame: Month 36
Secondary outcomes:
measure: Mean annual myopic progression
timeFrame: Month 36
measure: Proportion of participants with annual myopia progression rate <=0.50 D/year
timeFrame: Through Month 36
measure: Proportion of participants with annual myopia progression rate <=0.25 D/year
timeFrame: Through Month 36
measure: Proportion of participants with annual myopia progression rate > 0.50 D/year
timeFrame: Month 36
measure: Time to progression of myopia >0.75 D (diopters)
timeFrame: Up to 36 months (from date of randomization until date myopia progresses >0.75 D)
measure: Mean change from baseline in axial length
timeFrame: Baseline to Month 36
Other outcomes:
Locations:
city: Irwindale
country: United States
facility: Site 143
state: California
city: Pasadena
country: United States
facility: Site 144
state: California
city: San Diego
country: United States
facility: Site 148
state: California
city: San Diego
country: United States
facility: Site 104
state: California
city: Santa Barbara
country: United States
facility: Site 110
state: California
city: Sunnyvale
country: United States
facility: Site 133
state: California
city: Colorado Springs
country: United States
facility: Site 130
state: Colorado
city: Fort Collins
country: United States
facility: Site 100
state: Colorado
city: Danbury
country: United States
facility: Site 102
state: Connecticut
city: Waterbury
country: United States
facility: Site 150
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Site 122
state: Florida
city: Jupiter
country: United States
facility: Site 109
state: Florida
city: Sweetwater
country: United States
facility: Site 119
state: Florida
city: Tamarac
country: United States
facility: Site 120
state: Florida
city: Marietta
country: United States
facility: Site 124
state: Georgia
city: Chicago
country: United States
facility: Site 116
state: Illinois
city: Wilmette
country: United States
facility: Site 106
state: Illinois
city: Indianapolis
country: United States
facility: Site 135
state: Indiana
city: Munster
country: United States
facility: Site 131
state: Indiana
city: Pittsburg
country: United States
facility: Site 137
state: Kansas
city: Bangor
country: United States
facility: Site 138
state: Maine
city: Boston
country: United States
facility: Site 123
state: Massachusetts
city: Washington
country: United States
facility: Site 114
state: Missouri
city: Henderson
country: United States
facility: Site 132
state: Nevada
city: Albuquerque
country: United States
facility: Site 139
state: New Mexico
city: Buffalo
country: United States
facility: Site 127
state: New York
city: Chapel Hill
country: United States
facility: Site 117
state: North Carolina
city: Raleigh
country: United States
facility: Site 121
state: North Carolina
city: Fargo
country: United States
facility: Site 105
state: North Dakota
city: Medford
country: United States
facility: Site 111
state: Oregon
city: Tigard
country: United States
facility: Site 147
state: Oregon
city: Bala-Cynwyd
country: United States
facility: Sie 136
state: Pennsylvania
city: Cranberry Township
country: United States
facility: Site 128
state: Pennsylvania
city: Charleston
country: United States
facility: Site 108
state: South Carolina
city: Lakeway
country: United States
facility: Site 126
state: Texas
city: San Antonio
country: United States
facility: Site 142
state: Texas
city: San Antonio
country: United States
facility: Site 101
state: Texas
city: The Woodlands
country: United States
facility: Site 115
state: Texas
city: Ogden
country: United States
facility: Site 149
state: Utah
city: Ogden
country: United States
facility: Site 140
state: Utah
city: Virginia Beach
country: United States
facility: Site 113
state: Virginia
city: Linz
country: Austria
facility: Site 203
state: Oberosterreich
city: Graz
country: Austria
facility: Site 204
state: Styria
city: Vienna
country: Austria
facility: Site 205
city: Bratislava
country: Slovakia
facility: Site 202
city: Trebišov
country: Slovakia
facility: Site 201
city: Trenčín
country: Slovakia
facility: Site 200
Study officials:
References: