Effect of timolol maleate on general structural characteristics of the cornea in patients with keratoconus (abnormal conical shape of the cornea).

• Conditions: Keratoconus; MedDRA version: 14.1Level: PTClassification code 10023353Term: KeratoconusSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2012-004410-34-ES
• Lead Sponsor: Cristina Peris Martínez

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-29
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

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

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

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

Study & Design

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