EUCTR2014-005273-37-FI
Active, not recruiting
Phase 1
A phase IV study on the changes in ocular signs and symptoms in patientswith 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%)
ConditionsGlaucoma or Ocular HypertensionMedDRA version: 17.1Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disordersMedDRA version: 17.1Level: PTClassification code 10030348Term: Open angle glaucomaSystem Organ Class: 10015919 - Eye disordersMedDRA version: 17.1Level: PTClassification code 10074026Term: Exfoliation glaucomaSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
DrugsTaptiqom
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Glaucoma or Ocular Hypertension
- Sponsor
- Santen Oy
- Enrollment
- 120
- Status
- Active, not recruiting
- Last Updated
- 9 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 Screening.
- •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
- •Number of subjects for this age range:
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
Outcomes
Primary Outcomes
Not specified
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