treatment of adult amblyopia - amblyopia due to myopic or hyperopic anisometropia, or, congenital esotropia. MedDRA version: 14.1 Level: LLT Classification code 10065008 Term: Amblyopia unilateral System Organ Class: 10015919 - Eye disorders MedDRA version: 14.1 Level: LLT Classification code 10015475 Term: Esotropia System Organ Class: 10015919 - Eye disorders MedDRA version: 14.1 Level: LLT Classification code 10042158 Term: Strabismic amblyopia System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: Seronil 20 mg hard capsule
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: FLUOXETINE HYDROCHLORIDE
CAS Number: 59333-67-4
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
Hermo Pharma Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provide written informed consent, i.e. they must be willing and able to comply with the study procedures. 2. Male or female, aged 18-60 years (inclusive). 3. Diagnosed with amblyopia due to myopic or hyperopic anisometropia, or, congenital esotropia. 4. Visual acuity in the amblyopic eye =0.30 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Diagnosed with other reasons for strabismus as the primary reason for amblyopia. 2. History of any amblyopia therapy in the 2 years before the screening visit. 3. Any eye surgery less than 6 months before the screening visit. 4. Observed off-fixation by ophthalmological examination (extra-foveal fixation) 5. Other ophthalmological pathologies that may affect the patient’s rehabilitation. 6. Pregnant, planning to become pregnant during the study, or breast feeding. 7. History of depressive illness or treatment with antidepressant medication within 6 months before the screening visit. 8. Use of psychiatric medication within 6 months before the screening visit. 9. Receipt of an experimental treatment for any disease within 4 weeks before the screening visit. 10. History or presence of illicit drug use or alcohol abuse. 11. History or presence of any medical or psychiatric condition or disease, or laboratory abnormality that, in the opinion of the Investigator, may place the patient at unacceptable risk or that could prevent the patient from completing the study. 12. Hypersensitivity to fluoxetine or any of its excipients. 13. Epilepsy or a history of seizures. 14. History of mania or hypomania. 15. Concomitant treatment with any of the following medications that are known to interact with fluoxetine: a. Monoamine oxidase inhibitor (MAOI) - less than 2 weeks after discontinuation of an irreversible MAOI, or, less than one day after discontinuation of a reversible MAOI-A. b. Phenytoin. c. Serotonergic drugs. d. Lithium or tryptophan. e. Drugs predominantly metabolized by CYP2D6 isoenzyme, e.g. flecainide, encainide, carbamazepine and tricyclic antidepressants. f. Oral anticoagulants. g. St John’s Wort (Hypericum perforatum). h. Benzodiazepines.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the improvement in visual acuity in the amblyopic eye as measured by Early Treatment of Diabetic Retinopathy Study (ETDRS) chart after 10 weeks of medication (fluoxetine 20 mg) and computer software-based training combined with occlusion of the dominant eye. A clinically significant improvement is defined as a negative change of 0.2 logarithm of the minimum angle of resolution (logMAR) units (i.e. 10 characters on the ETDRS chart). ;Secondary Objective: • improvement in visual acuity 3 months after treatment. • stability of the change in visual acuity during follow-up. • relative change in visual acuity after 10 weeks of treatment. • relative improvement in visual acuity 3 months after treatment • difference in relative change in visual acuity after 10 weeks of treatment • difference in relative change in visual acuity 3 months after treatment • change in contrast sensitivity in the amblyopic eye after 10 weeks of treatment • change in contrast sensitivity 3 months after treatment • stability of change in contrast sensitivity during follow-up • change in binocularity after 10 weeks of treatment • change in binocularity 3 months after treatment • stability of change in binocularity during follow-up • change in near vision and crowding after 10 weeks of treatment • change in near vision and crowding 3 months after treatment • stability of change in near vision and crowding during follow-up • safety of fluoxetine ;Primary end point(s): The primary endpoint is the change from baseline (Week 0) to end of treatment (Week 10) in visual acuity in the amblyopic eye as measured by ETDRS chart.;Timepoint(s) of evaluation of this end point: Change from baseline (week 0) to end of treatment (10 weeks). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change from baseline (Week 0) to end of follow-up (Week 22) in visual acuity in the amblyopic eye as measured by ETDRS chart. • Change from end of treatment (Week 10) to end of follow-up (Week 22) in visual acuity in the amblyopic eye as measured by ETDRS chart. • Relative change (%) in visual acuity in the amblyopic eye from baseline (Week 0) to end of treatment (Week 10) as measured by ETDRS chart. • Relative change (%) in visual acuity in the amblyopic eye from baseline (Week 0) to end of follow-up (Week 22) as measured by ETDRS chart. • Difference between the dominant and amblyopic eye in relative change (%) in visual acuity from baseline (Week 0) to end of treatment (Week 10) as measured by ETDRS chart. • Difference between the dominant and amblyopic eye in relative change (%) in visual acuity from baseline (Week 0) to end of follow-up (Week 22) as measured by ETDRS chart. • Change from baseline (Week 0) to end of treatment (Week 10) in contrast sensitivity in the amblyopic eye as measured by Pelli Robson chart. • Change from baseline (Week 0) to end of follow-up (Week 22) in contrast sensitivity in the amblyopic eye as measured by Pelli-Robson chart. • Change from end of treatment (Week 10) to end of follow-up (Week 22) in contrast sensitivity in the ablyopic eye as measured by Pelli-Robson chart. • Change from baseline (Week 0) to end of treatment (Week 10) in binocularity as measured by Bagolini striated glass test. • Change from baseline (Week 0) to end of follow-up (Week 22) in binocularity as measured by Bagolini striated glass test. • Change from end of treatment (Week 10) to end of follow-up (Week 22) in binocularity as measured by Bagolini striated glass test. • Change from baseline (Week 0) to end of treatment (Week 10) in near vision and crowding as measured by Landolt C ring charts. • Change from baseline (Week 0) to end of follow-up (Week 22) in near vision and crowding as measured by Landolt C ring charts. • Change from e | — |
Countries
Estonia, Finland
Contacts
Public ContactClinical Development information
Hermo Pharma Ltd.
Outcome results
None listed