Keratoconus MedDRA version: 14.1 Level: PT Classification code 10023353 Term: Keratoconus System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: Timogel 1mg/g 30 monodosis
Pharmaceutical Form: Eye drops, solution in single-dose container
INN or Proposed INN: Timolol maleate
CAS Number: 26921-17-5
Other descriptive name: TIMOLOL MA
Sponsors
Cristina Peris Martínez
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male or female, from 18 years of age. 2.Patients with keratoconus grade I, II, or III on the Amsler-Krumeick scale 3.Patient must provide written informed consent. 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1.Patient with keratoconus grade IV on the Amsler-Krumeick 2.Any other ectasia including secundary ioatrogenic ectasia after Lasik surgery, radial keratotomy, traumatic ectasia, etc. 3.Lid anatomic or functional anomaly affecting blinking function 4. Any ocular or systemic pathology affecting the normal ocular function and interfering with study results. 5. Contact lenses wear at the inclusion visit and for whole study time. 6. Any corneal surgery. 7. Any ocular surgery including refractive surgery, intraocular surgery or lid surgery, modifying the corneal surface of the patients. 8. History of any ocular trauma, ocular inflammation or ocular infection (viral, bacterial, fungal, protozoal). 9. Within the 30 days before the Screening Visit history of any ocular pathology requesting topical treatment. 10. Patients with glaucoma or ocular hypertension 11. Medical history of corneal dystrophy or showing the pathology at the selection visit. 12. Best corrected distance visual acuity (BCDVA) score ? 35 ETDRS letters or ? 20/200 Snellen. 13. Patients using systemic or ocular treatment for glaucoma or ocular hypertension, including other beta-blockers agents 14. Patients using any other treatment which increases or decreases intraocular pressure 15. Patients using any eye drop containing adrenaline 16. Presence or history of cancer, other serious diseases and metabolic serious diseases. 17. Patient with aggressive treatment since last year. 18. Patient with not controlled disease since 6 months (arterial hypertension, thyroid dysfunction, autoimmune disease, patients with improper metabolic control including out range glycaemia. 19. Presence or history of respiratory disease of asthma, COPD, bronchial hyperactivity, allergic rhinitis. 20. Presence or history of cardiovascular diseases such as cardiac insufficiency, cardiogenic shock, 2nd and 3th degree AV block, bradycardia, Reynaud disease, peripheral circulation distress, hypotension 21. Patients with pheochromacytoma 22. Presence or history of metabolic acidosis 23. Presence or history of psoriasis 24. Medical history of anaphylactic reaction 25 Any change on systemic within 30 days before to the screening visit, or any unexpected change of medication during the whole study 26. Patients with allergic response to study drugs, to study related drugs or to drugs used during study procedures 27. Medical history of neoplastic disease in last 5 years 28. Pregnant or child feeding women 29. Childbearing women not using contraception methods 30. Patients being treated with floctafenin and sultopride or having treated with them in the last 30 days before inclusion visit 31. Patients receiving systemic treatment of bepridil, verapamil and/or diltiazem or having used them in the last 30 days before inclusion visit 32. Patients receiving systemic treatment of beta-blockers or having used them in the last 30 days before inclusion visit 33. Patients receiving any systemic treatment having negative effect on cardiac conductibility (amiodarone, propafenone, anti-bradicardia agents, etc) or having used them in the last 7 days before inclusion visit 34. Patients receiving any systemic treatment increasing the beta-blocking or hypotensive effect (quinidine, baclofen, imipramine, etc) or having used them in the last 7 days before inclusion visit 35. Patients receiving any systemic treatment having antihypertensive effect (central hypertensive drugs, NSAID, dipiramidol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: -Determination of a possible relationship between the improvement of keratometry and corneal biomechanic parameters and the decrease of the intraocular pressure. -Establish de safety of timolol maleate treatment in patients with keratoconus.;Main Objective: - Decrease in the keratometry measurement in patients with keratoconus. - Improvement in the corneal biomechanic parameters (corneal hysteresis-CH and corneal resistance factor-CRF) in patients with keratoconus.;Primary end point(s): -Achieving the decrease on the patient keratometry. Decrease of at least 1 grade from baseline measurement will be considered as probed efficiency. -Improving corneal biomechanic parameters (corneal hysteresis and corneal resistance factor): a decrease from baseline on biomechanic parameters of at least 30% will be considered as efficient.;Timepoint(s) of evaluation of this end point: Analysis of both primary variable of clinic efficiency, keratometry and corneal biomechanic parameters, will be performed at last visit, visit 5 on month 6. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Establishing the possible relationship between improvement of keratometry, and corneal biomechanic parameters and decrease in the intraocular pressure. - Establishing the safety of the treatment, showing treatment effects on corneal epithelium.;Timepoint(s) of evaluation of this end point: Measurements and analysis of all secundary variable will be performed during complete study trial at visit 2, 3, 4 and 5 | — |
Countries
Spain
Contacts
Public ContactCristina Peris Martínez
Cristina Peris Martínez
Outcome results
None listed