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

Primary Purpose

Nearsightedness, Near Sightedness, Near-sightedness

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SYD-101 Dose 1
SYD-101 Dose 2
Vehicle
Sponsored by
Sydnexis, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nearsightedness focused on measuring Children, Myopia

Eligibility Criteria

3 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Site 143
  • Site 144
  • Site 148
  • Site 104
  • Site 110
  • Site 133
  • Site 130
  • Site 100
  • Site 150
  • Site 102
  • Site 119
  • Site 122
  • Site 109
  • Site 120
  • Site 124
  • Site 116
  • Site 106
  • Site 135
  • Site 131
  • Site 137
  • Site 138
  • Site 123
  • Site 114
  • Site 132
  • Site 139
  • Site 127
  • Site 117
  • Site 121
  • Site 105
  • Site 111
  • Site 147
  • Sie 136
  • Site 128
  • Site 108
  • Site 126
  • Site 142
  • Site 101
  • Site 115
  • Site 149
  • Site 140
  • Site 113
  • Site 203
  • Site 204
  • Site 205
  • Site 202
  • Site 201
  • Site 200

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Part 1: SYD-101 Dose 1; Part 2: SYD-101 Dose 1

Part 1: SYD-101 Dose 1; Part 2: Vehicle

Part 1: SYD-101 Dose 2; Part 2: SYD-101 Dose 2

Part 1: SYD-101 Dose 2; Part 2: Vehicle

Part 1: Vehicle; Part 2: SYD-101 Dose 2

Arm Description

1 drop in each eye at bedtime.

1 drop in each eye at bedtime.

1 drop in each eye at bedtime.

1 drop in each eye at bedtime.

1 drop in each eye at bedtime.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mean annual myopic progression
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 <=0.50 D/year
Mean annual progression rate of myopia
Proportion of participants with annual myopia progression rate <=0.25 D/year
Mean annual progression rate of myopia
Proportion of participants with annual myopia progression rate > 0.50 D/year
Mean annual progression rate of myopia
Time to progression of myopia >0.75 D (diopters)
Progression of myopia measured as Spherical Equivalent (SE) via cycloplegic autorefraction.
Mean change from baseline in axial length
Measured by cycloplegic biometry

Full Information

First Posted
April 12, 2019
Last Updated
October 10, 2023
Sponsor
Sydnexis, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03918915
Brief Title
The Safety and Efficacy of SYD-101 in Children With Myopia
Acronym
STAR
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 24, 2019 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sydnexis, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nearsightedness, Near Sightedness, Near-sightedness
Keywords
Children, Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
852 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1: SYD-101 Dose 1; Part 2: SYD-101 Dose 1
Arm Type
Experimental
Arm Description
1 drop in each eye at bedtime.
Arm Title
Part 1: SYD-101 Dose 1; Part 2: Vehicle
Arm Type
Experimental
Arm Description
1 drop in each eye at bedtime.
Arm Title
Part 1: SYD-101 Dose 2; Part 2: SYD-101 Dose 2
Arm Type
Experimental
Arm Description
1 drop in each eye at bedtime.
Arm Title
Part 1: SYD-101 Dose 2; Part 2: Vehicle
Arm Type
Experimental
Arm Description
1 drop in each eye at bedtime.
Arm Title
Part 1: Vehicle; Part 2: SYD-101 Dose 2
Arm Type
Placebo Comparator
Arm Description
1 drop in each eye at bedtime.
Intervention Type
Drug
Intervention Name(s)
SYD-101 Dose 1
Other Intervention Name(s)
atropine sulfate
Intervention Description
Sterile topical ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
SYD-101 Dose 2
Other Intervention Name(s)
atropine sulfate
Intervention Description
Sterile topical ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Vehicle
Other Intervention Name(s)
Control, Placebo
Intervention Description
Sterile topical ophthalmic solution without active ingredient
Primary Outcome Measure Information:
Title
Myopic progression >0.75 D (diopters)
Description
Proportion of participants with confirmed myopic progression >0.75 D (diopters), based on SE (spherical equivalent) as measured by cycloplegic autorefraction
Time Frame
Month 36
Secondary Outcome Measure Information:
Title
Mean annual myopic progression
Description
Mean annual progression rate of myopia measured in diopters: Spherical Equivalent (SE) as measured by cycloplegic autorefraction.
Time Frame
Month 36
Title
Proportion of participants with annual myopia progression rate <=0.50 D/year
Description
Mean annual progression rate of myopia
Time Frame
Through Month 36
Title
Proportion of participants with annual myopia progression rate <=0.25 D/year
Description
Mean annual progression rate of myopia
Time Frame
Through Month 36
Title
Proportion of participants with annual myopia progression rate > 0.50 D/year
Description
Mean annual progression rate of myopia
Time Frame
Month 36
Title
Time to progression of myopia >0.75 D (diopters)
Description
Progression of myopia measured as Spherical Equivalent (SE) via cycloplegic autorefraction.
Time Frame
Up to 36 months (from date of randomization until date myopia progresses >0.75 D)
Title
Mean change from baseline in axial length
Description
Measured by cycloplegic biometry
Time Frame
Baseline to Month 36

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Site 143
City
Irwindale
State/Province
California
ZIP/Postal Code
91706
Country
United States
Facility Name
Site 144
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Site 148
City
San Diego
State/Province
California
ZIP/Postal Code
92127
Country
United States
Facility Name
Site 104
City
San Diego
State/Province
California
ZIP/Postal Code
92131
Country
United States
Facility Name
Site 110
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93110
Country
United States
Facility Name
Site 133
City
Sunnyvale
State/Province
California
ZIP/Postal Code
94087
Country
United States
Facility Name
Site 130
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80920
Country
United States
Facility Name
Site 100
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Site 150
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Site 102
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Site 119
City
Doral
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
Site 122
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33309
Country
United States
Facility Name
Site 109
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33477
Country
United States
Facility Name
Site 120
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Site 124
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Site 116
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
Site 106
City
Wilmette
State/Province
Illinois
ZIP/Postal Code
60091
Country
United States
Facility Name
Site 135
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Site 131
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Facility Name
Site 137
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Site 138
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Site 123
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Site 114
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
Site 132
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Site 139
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Site 127
City
Buffalo
State/Province
New York
ZIP/Postal Code
14209
Country
United States
Facility Name
Site 117
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Facility Name
Site 121
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27603
Country
United States
Facility Name
Site 105
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Site 111
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Site 147
City
Tigard
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Sie 136
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004-1108
Country
United States
Facility Name
Site 128
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Site 108
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Site 126
City
Lakeway
State/Province
Texas
ZIP/Postal Code
78734
Country
United States
Facility Name
Site 142
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Site 101
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Site 115
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
Site 149
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Site 140
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Site 113
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23452
Country
United States
Facility Name
Site 203
City
Linz
State/Province
Oberosterreich
ZIP/Postal Code
4021
Country
Austria
Facility Name
Site 204
City
Graz
State/Province
Styria
ZIP/Postal Code
8036
Country
Austria
Facility Name
Site 205
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Facility Name
Site 202
City
Bratislava
ZIP/Postal Code
833 40
Country
Slovakia
Facility Name
Site 201
City
Trebišov
ZIP/Postal Code
075 01
Country
Slovakia
Facility Name
Site 200
City
Trenčín
ZIP/Postal Code
91108
Country
Slovakia

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.fda.gov/Safety/Recalls
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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