Eye Disease Myopia
Conditions
Interventions
All subjects will receive one drop of study drug in each eye at bedtime:
* OT-101 Ophthalmic Solution (QD)
* Placebo (vehicle) ophthalmic solution (QD)
Sponsors
Ocumension (Hong Kong) Limited
Eligibility
Age
2 Years to 15 Years
Inclusion criteria
Inclusion criteria: Subjects must: 1. A parent or legal guardian of each subject must provide written informed consent and sign the HIPAA form (or equivalent, if applicable), approved by the appropriate Institutional Review Board (IRB)/Ethical Committee (EC). Whenever practical and appropriate per local requirements, a child*s assent should also be sought before inclusion into the study; 2. Be able to comply with study requirements, attend all study visits, have ability to read and understand native language of subject and be accompanied by a parent/legal guardian; 3. Be between 3-15 years of age of either sex and any race or ethnicity at Visit 1 (Day -14 to -1); 4. Have refractive error by cycloplegic autorefraction at baseline (Visit 1) of: a) myopia between -1.00D and -6.00 D, inclusive of spherical equivalent b) astigmatism less than or equal to 1.50 DC 5. Have anisometropia * 1.0D of spherical equivalent at Visit 1; 6. Have a best-corrected distance visual acuity of (BCVA) of logarithm of the minimum angle of resolution (logMAR) *0.4 (approximately Snellen 20/50) for 3 year olds; logMAR *0.3 (approximately Snellen 20/40) for 4 year olds; logMAR *0.18 (approximately Snellen 20/30) for *5 year olds) in each eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart [R,1 or 2], or Lea Chart for subjects who do not know the alphabet, at Visit 1 and Visit 2; 7. Be able and willing to avoid all prohibited medications during the washout period between screening and randomization and during the study without significant risk to the subject.
Exclusion criteria
Exclusion criteria: Subjects must not: 1. Have known contraindications or sensitivity to atropine, the study medications, or their components; 2. Have clinically significant abnormal findings on slit lamp biomicroscopy exam (e.g. cataract) which may impact best corrected visual acuity measures in either eye at screening or a known history of a clinically significant slit lamps findings in either eye; 3. Have clinically significant abnormal findings on indirect dilated fundoscopy exam in either eye at screening or a known history of a clinically significant retinal findings in either eye; 4. Have any evidence of an eye movement disorder or restriction of extraocular movement (e.g. nystagmus); 5. Have an active ocular infection (i.e. bacterial, viral, or fungal); 6. Have active or a history of chronic or recurrent episodes of ocular inflammation (e.g. moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis) in either eye; 7. Have a history of ocular herpetic infection, iritis, scleritis, or uveitis, whether active or inactive at screening; 8. Have undergone any myopia control treatment including atropine, orthokeratology, rigid gas-permeable contact lenses, bifocal contact lenses, progressive addition spectacle lenses, or other lenses to reduce myopia progression in the previous 6 months. Myopic correction in the form of single-vision eyeglasses and/or single-vision soft contact lenses are allowed; 9. Have undergone any form of refractive eye surgery including incisional keratotomy, photorefractive keratectomy [PRK], laser in situ keratomileusis [LASIK], laser-assisted sub- epithelial keratectomy [LASEK]), corneal inlay procedures, conductive keratoplasty, small incision lenticule extraction (SMILE), cataract extraction, or any form of intraocular lens implantation; 10. Have intraocular pressure (IOP) that is 21 mmHg in either eye, or have a prior diagnosis of ocular hypertension or glaucoma or currently being treated with any type of topical IOP lowering (glaucoma) medication; 11. Have had surgical intervention (ocular or systemic) within 6 months prior to Visit 1, or planned surgical intervention during the study; 12. Use any of the following disallowed medications or therapies by any route of administration during the 2 weeks (14 days) prior to Visit 2 (Day 1): a. any prescription or over the counter ophthalmic products (Use of preservative-free artificial tears is allowed but may not be used within 2 hours of administration of study medication. Use of lubricating ointment form of artificial tears before bedtime is allowed but must be used at least 15 minutes after administration of study medication.) b. monoamine oxidase inhibitors c. atropine, pirenzepine, or other anti-muscarinic agent d. any medication affecting the pupil or accommodation e. orthoK, rigid gas-permeable, bifocal, progressive-addition, multi-focal, or other lenses to reduce myopia progression In addition, Groups b * e above are not allowed for the duration of the study. 13. The anticipated need to use chronic ophthalmic or systemic oral corticosteroids during the study. Intranasal, inhaled, topical dermatologic, intra-articular, perianal steroids, and short-term oral steroids (< 2 weeks) are permitted; 14. Participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy Endpoint: Percentage of subjects with a -0.75D of progressive myopia at Month 36 defined as an increase in spherical equivalent of -0.75D or greater as assessed by cycloplegic autorefraction. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key Secondary * Change from baseline to Month 36 in study eye spherical equivalent (D) as assessed by cycloplegic autorefraction * Change from baseline to Month 36 in study eye axial length as measured by cycloplegic biometry (will be selected and the same device to be used throughout the duration of this study) Secondary * Percentage of study eyes with annual myopia progression rate through Month 36 * -0.50 D * Change from baseline to each visit through Month 36 in study eye spherical equivalent (D) as assessed by cycloplegic autorefraction * Percentage of study eyes with a -0.75 D of progressive myopia from Month 36 to each post-Month 36 visit defined as an increase in spherical equivalent of -0.75 D or greater as assessed by cycloplegic autorefraction * Change from Month 36 to each post-Month 36 visit in study eye spherical equivalent (D) as assessed by cycloplegic autorefraction * Change from baseline to each visit in study eye axial length as measured by cycloplegic biometry (will be selected and the same device to be used throughout the duration of this study) * Change from baseline to Month 24 and 36 in study eye spherical equivalent (D) as assessed by manual cycloplegic refraction * Percentage of study eyes within each of the following change from baseline spherical equivalent categories at each visit: *-0.50 D, -0.75 D, -1.0 D, -1.5 D or greater (in 0.5 D increments) as assessed by cycloplegic autorefraction Percentage of study eyes within each of the following change from Month 36 spherical equivalent categories to each post-Month 36visit: *-0.50 D, - 0.75 D, -1.0 D, -1.5 D or greater (in 0.5 D increments) as assessed by cycloplegic autorefraction | — |
Countries
Netherlands
Outcome results
None listed