Combination treatment of antidepressant medication with eye training program to treat lazy eye in adults.

• Conditions: treatment of adult amblyopia - amblyopia due to myopic or hyperopic anisometropia, or, congenital esotropia.; MedDRA version: 14.1Level: LLTClassification code 10065008Term: Amblyopia unilateralSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: LLTClassification code 10015475Term: EsotropiaSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: LLTClassification code 10042158Term: Strabismic amblyopiaSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: PTClassification code 10001906Term: AmblyopiaSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2010-023216-14-FI
• Lead Sponsor: Hermo Pharma Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-20
• Last Update Posted: 20 May 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 <1.10 logMAR (at least one character on the ETDRS chart).
5. Visual acuity in the dominant eye =0.10 logMAR.
6. Anisometropia =4.25 diopters.
7. Judged to be otherwise healthy by the Investigator, based on medical history, brief physical examination, eye examination and clinical laboratory assessments. Patients with abnormal clinical laboratory values or who have other abnormal clinical findings that are judged by the Investigator not to be of clinical significance may be entered into the study.
6. Females of childbearing potential are eligible for the study provided (i) they have a negative urine pregnancy test at the screening visit and (ii) they agree to use adequate contraception (e.g. oral, depot or implanted hormonal contraception, intrauterine device, surgical sterilization or partner vasectomy) from the screening visit until at least 4 weeks after the last dose of study medication (Week 16).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 67
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified