Pediatric glaucoma
Conditions
Interventions
Trade Name: TIMOLOL MALEATE Ophthalmic Solution USP, 0.25%
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: Timolol
CAS Number: 26921-17-5
Other descriptive name: TIMOLOL
Concentration un
Sponsors
Alcon Research Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients 2 months to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Females of childbearing potential are excluded from participation in the study if they meet any of the following conditions: a. They are currently pregnant b. They have a positive result on a pregnancy test at the Screening Visit c. They intend to become pregnant during the study period d. They are breast feeding e. They are not using any of the following highly effective birth control measures: • True abstinence – when this is in line with the preferred and usual lifestyle of the subject. If subjects become sexually active, they must agree to use one of the birth control methods (hormonal, mechanical, or surgical) listed below for the remainder of the study. • Hormonal – implanted contraceptives. • Mechanical –IUD with progestogen. • Surgical – vasectomized partner (must be = 6 months post vasectomy). Note: All females of childbearing potential must consent to a urine pregnancy test at the Screening Visit and upon exiting the study. Note: Females of childbearing potential will be instructed to immediately inform the Investigator if they become pregnant during the study. Should this occur, the Investigator shall immediately contact the Sponsor). 2. Patients who have previously failed long-term treatment with a prostaglandin analog or timolol to control IOP or patients in which reasonable IOP control would not be expected from pharmacological treatment. 3. History of chronic, recurrent or severe inflammatory eye disease (ie, scleritis, uveitis, herpes keratitis). 4. Ocular trauma requiring medical attention within the past 3 months prior to the Screening Visit. 5. Ocular infection or ocular inflammation within the past 30 days prior to the Screening Visit. 6. Clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment in the study eye. 7. Severe ocular pathology (including severe dry eye) in the opinion of the Investigator that would preclude the administration of a topical prostaglandin analog or a topical beta-blocker. 8. Intraocular surgery within the past 30 days in the study eye prior to the Screening Visit. 9. Any abnormality preventing reliable applanation tonometry, including a history of penetrating keratoplasty. 10. Patients with a history of previous cyclodestructive procedure. 11. Any other conditions including severe illness which would make the patient, in the opinion of the Investigator, unsuitable for the study. 12. Hypersensitivity to any component of the study medications, including medications administered during study exams, in the opinion of the Investigator. 13. History of congenital cardiovascular anomalies or abnormalities which would preclude the safe administration of a topical beta-blocker. In the event that the effects of the study medications are unclear, the patient may participate with written approval from the patient’s cardiologist. There is a potential for additive effects resulting in hypotension and/or marked bradycardia when eye drops with timolol are administered concomitantly with oral calcium channel blockers, quanethidine or beta-blocking agents, antiarrhythmics, digitalis glycosides or parasympathomimetics. The hypertensive reaction to sudden withdrawal of clonidine or can be potentiated when taking beta-blockers. Potentates systemic beta-blockade (e.g. decreased heart rate) has been reported during combined treatment with CYP2D6 inhibitors (e.g. quinidine, cimetidine) and timolol. Beta-bloc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Primary Efficacy • IOP change from baseline at Month 3 Secondary Efficacy • Not applicable Supportive Efficacy • IOP change from baseline at Week 2 and Week 6 • IOP and IOP percent change from baseline at each visit (Week 2, Week 6, and Month 3) • Percentage of patients who achieve at least a 15% reduction at each visit (Week 2, Week 6, and Month 3) • Percentage of patients who reach an IOP within a normal range;Timepoint(s) of evaluation of this end point: Week 2, Week 6 and Month 3;Main Objective: The primary objective of this study is to demonstrate that the IOP-lowering efficacy of Travoprost Ophthalmic Solution, 0.004% (preserved with POLYQUAD) is noninferior to Timolol Ophthalmic Solution (0.5% or 0.25%) in pediatric glaucoma patients.;Secondary Objective: Not Applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not Applicable | — |
Countries
Belgium, Brazil, Colombia, France, Germany, India, Mexico, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Spain, Taiwan, Ukraine, United Kingdom, United States
Contacts
Public ContactHead of EURMEA Regulatory Affairs
Alcon Eye Care UK Limited
Outcome results
None listed