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

Nearsightedness Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03918915
• Other study ID #: SYD-101-001
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 24, 2019
• Est. completion date: June 2025

Study information

• Verified date: February 2024
• Source: Sydnexis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 852
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia
• Near Sightedness
• Near-sightedness
• Nearsightedness

Intervention

Drug:
• SYD-101 Dose 1
Sterile topical ophthalmic solution
• SYD-101 Dose 2
Sterile topical ophthalmic solution
• Vehicle
Sterile topical ophthalmic solution without active ingredient

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sydnexis, Inc.

Countries where clinical trial is conducted

United States,  Austria,  Slovakia, 

Outcome

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

External Links

•   FDA Safety Alerts and Recalls