EUCTR2014-005273-37-IT
Active, not recruiting
Phase 1
A phase IV study on changes in ocular signs and symptoms in patients with with ocular hypertension or open-angle glaucoma switched from Ganfort¿eye drops (bimatoprost 0.03%/timolol 0.5%) to Taptiqom¿ eye drops (tafluprost 0.0015%/timolol 0.5%) - Clinical Trial on changes in ocular signs and symptoms in patients with ocular hypertension or open
ConditionsGlaucoma or Ocular HypertensionMedDRA version: 20.0Level: PTClassification code 10030348Term: Open angle glaucomaSystem Organ Class: 10015919 - Eye disordersMedDRA version: 20.0Level: PTClassification code 10074026Term: Exfoliation glaucomaSystem Organ Class: 10015919 - Eye disordersMedDRA version: 20.0Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Glaucoma or Ocular Hypertension
- Sponsor
- SANTEN OY
- Enrollment
- 123
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Aged 18 years or more
- •2\. A diagnosis of ocular hypertension or open\-angle glaucoma (either
- •POAG or PEX) in one or both eyes, for which the patient has been
- •regularly using Ganfort® in the evening for at least 4 weeks before
- •3\. In the Screening visit evaluation, the presence of:
- •\- conjunctival redness/hyperemia at least in one treated eye
- •\- at least one ocular symptom considered for the two eyes together (irritation/burning/stinging, foreign body sensation, tearing, itching or dry eye
- •4\. A best corrected ETDRS visual acuity score of \+0\.6 logMAR or better in both eyes
- •5\. Have provided a written informed consent and are willing to follow instructions
- •Are the trial subjects under 18? no
Exclusion Criteria
- •1\. Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception
- •2\. Use of more than two active medicinal agents to treat glaucoma/OH during the past six months prior to Screening
- •3\. Anterior chamber angle in either eye to be treated less than grade 2 according to Schaffer classification as measured by gonioscopy
- •4\. Any corneal abnormality or other condition preventing reliable applanation tonometry,including prior refractive eye surgery
- •5\. IOP greater than 21 mmHg in treated eye(s) at Screening/Baseline visit
- •6\. Use of preserved eye drops (other than Ganfort®) including artificial tears at screening or within two weeks prior to screening visit
- •7\. Diagnosis of angle\-closure glaucoma or secondary glaucoma other than PEX in either eye
- •8\. Suspected contraindication to tafluprost or timolol therapy (low heart rate or clinically relevant low blood pressure for age, chronic obstructive
- •pulmonary disease, bronchial asthma, strong tendency to bronchospasm, certain cardiac arrhythmias or uncontrolled congestive heart failure)
- •9\. Glaucoma filtration surgery or any other ocular surgery (including ocular laser procedures) within 6 months prior to Screening in eye(s) to be treated with study medication
Outcomes
Primary Outcomes
Not specified
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