Glaucoma or Ocular Hypertension MedDRA version: 17.1 Level: HLGT Classification code 10018307 Term: Glaucoma and ocular hypertension System Organ Class: 10015919 - Eye disorders MedDRA version: 17.1 Level: PT Classification code 10030348 Term: Open angle glaucoma System Organ Class: 10015919 - Eye disorders MedDRA version: 17.1 Level: PT Classification code 10074026 Term: Exfoliation glaucoma System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: Taptiqom
Product Name: Taptiqom
Pharmaceutical Form: Eye drops, solution in single-dose container
INN or Proposed INN: TIMOLOL MALEATE, R-ENANTIOMER
Other descriptive name: TAFLUPROST
Sponsors
Santen Oy
Eligibility
Sex/Gender
All
Inclusion 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 AND - at least one ocular symptom considered for the two eyes together (irritation/burning/stinging, foreign body sensation, tearing, itching or dry eye sensation) 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: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
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 10. Use of contact lenses at Screening or during the study 11. Any ocular, systemic or psychiatric disease/conditio that may put the patient at a significant risk or may confound the study results as judged by the investigator 12. Current alcohol or drug abuse 13. Current participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the last 30 days prior to Screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to investigate whether changes in ocular signs or symptoms occur when patients with OHT or OAG (POAG or PEX) are switched from Ganfort® eye drops (FDC of bimatoprost 0.03% and timolol 0.5%) to Taptiqom® eye drops (FDC of tafluprost 0.0015% and timolol 0.5%).;Secondary Objective: Not applicable;Primary end point(s): Change from screening in conjunctival redness/hyperemia at week 12 Change from screening in worst ocular symptom upon non-instillation at week 12;Timepoint(s) of evaluation of this end point: At 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from screening in ocular signs at week 12 (other than conjunctival redness/hyperemia) Change from screening in ocular symptoms upon non-instillation at week 12 Quality of Life ;Timepoint(s) of evaluation of this end point: At 12 weeks | — |
Countries
Finland, France, Germany, Italy, Spain, United Kingdom
Contacts
Public ContactManager, Clinical Research
Santen Oy
Outcome results
None listed