EUCTR2012-004410-34-ES进行中（未招募）不适用
Influence of timolol maleate (ophthalmic gel 1 mg/g) on the keratometry and the parameters of corneal biomechanics in patients with keratoconus.
Cristina Peris Martínez0 个研究点开始时间: 2012年10月29日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
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