Nearsightedness, Near-sightedness, Near Sightedness
Conditions
Keywords
Children, Myopia
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 3-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.
Interventions
DRUGSYD-101 0.01%
Sterile topical ophthalmic solution
DRUGSYD-101 0.03%
Sterile topical ophthalmic solution
DRUGVehicle
Sterile topical ophthalmic solution without active ingredient
Sponsors
Sydnexis, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 14 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 >=-0.50 D/Year | Through Month 36 | Proportion of participants with annual progression rate of myopia no worse than -0.50 D/year |
| Proportion of Participants With Annual Myopia Progression Rate >=-0.25 D/Year | Through Month 36 | Proportion of participants with annual progression rate of myopia no worse than -0.25D/year |
| Proportion of Participants With Increase of Myopia More Than -0.50 D | Month 36 | Proportion of participants with increase of myopia more than -0.50D |
| Time to Progression of Myopia <-0.75 D (Diopters) | Up to 36 months (from date of randomization until date myopia progresses < -0.75 D) | Time (days) to confirmed myopic progression of worse than -0.75D. Time to Progression (days) 95% CI is calculated for the median. |
| Mean Change From Baseline in Axial Length (Subset Only) | Baseline to Month 36 | Mean change from baseline in axial length at sites with requisite equipment |
Countries
Austria, Slovakia, United States
Participant flow
Pre-assignment details
The Full Analysis Set (FAS) comprised of all participants who were randomized (N= 852) and received at least 1 dose of study drug (N=847).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 10.4 years STANDARD_DEVIATION 2.42 |
| Baseline Spherical Equivalent | -2.73 Diopters STANDARD_DEVIATION 1.375 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 74 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 621 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants |
| Race (NIH/OMB) Asian | 55 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 580 Participants |
| Region of Enrollment Austria | 26 participants |
| Region of Enrollment Slovakia | 44 participants |
| Region of Enrollment United States | 777 participants |
| Sex: Female, Male Female | 472 Participants |
| Sex: Female, Male Male | 375 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 282 | 0 / 283 | 0 / 282 | 0 / 50 | 0 / 102 | 0 / 105 | 0 / 103 | 0 / 105 | 0 / 205 |
| other Total, other adverse events | 183 / 282 | 205 / 283 | 194 / 282 | 17 / 50 | 14 / 102 | 17 / 105 | 9 / 103 | 14 / 105 | 60 / 205 |
| serious Total, serious adverse events | 4 / 282 | 10 / 283 | 8 / 282 | 0 / 50 | 0 / 102 | 0 / 105 | 0 / 103 | 0 / 105 | 1 / 205 |
Outcome results
None listed