Patients diagnosed with Ocular Hypertension or Open-angle glaucoma (primary open-angle glaucoma [POAG] or capsular glaucoma) MedDRA version: 12.1 Level: LLT Classification code 10030856 Term: Open-angle glaucoma MedDRA version: 12.1 Level: LLT Classification code 10030043 Term: Ocular hypertension
Conditions
Interventions
Trade Name: TAFLOTAN 15 micrograms/ml eye drops, solution, single-dose container
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: Tafluprost
CAS Number: 209860-87-7
Concentration unit: µg
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 capsular glaucoma) in one or both eyes, for which the patient has been regularly using travoprost 0.004% (Travatan®) for at least six months before Screening. 3. In the Screening visit evaluation, the presence of: - At least two ocular symptoms considered for the two eyes together (irritation/burning/stinging, foreign body sensation, tearing, itching or dry eye sensation) of at least mild severity (grade = 2) upon non-instillation OR One ocular symptom of at least mild severity (grade = 2) upon non-instillation AND at least one of the following ocular signs in either eye with prior treatment: •Fluorescein tear break-up time (fBUT): less than 10 seconds •Corneal and conjunctival fluorescein staining: - Corneal fluorescein staining score of at least grade I OR - Combined nasal and temporal staining scores of at least grade II •Blepharitis: of at least mild severity (grade = 1) • Conjunctival redness/hyperemia: of at least mild severity (grade 1) • Tear production: 10 mm or less on Schirmer test 4. A best corrected ETDRS visual acuity score of +0.6 logMAR or better in both eyes 5. Are willing to follow instructions 6. Have provided a 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Females who are pregnant, nursing or planning pregnancy, or females of childbearing potential who are not using a reliable method of contraception1 2. Anterior chamber angle in either eye to be treated less than grade 2 according to Schaffer classification as measured by gonioscopy 3. Any corneal abnormality or other condition preventing reliable applanation tonometry, including prior refractive eye surgery 4. IOP greater than 22 mmHg at 15:00 IOP measurement in either eye at Screening/Baseline visit 5. Use of preserved eye drops (other than travoprost) including artificial tears at screening or within two weeks prior to screening visit 6. Diagnosis of angle-closure glaucoma or secondary glaucoma other than capsular glaucoma in either eye 7. Suspected contraindication to tafluprost therapy (hypersensitivity to tafluprost or any of the excipients). 8. 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 9. Use of contact lenses at Screening or during the study 10. Any ocular (e.g. aphakia, pseudophakia with torn posterior lens capsule2 or anterior chamber lenses, known risk factors for cystoid macular oedema or iritis/uveitis), systemic or psychiatric disease/condition (e.g. uncontrolled arterial hypertension, diabetes) that may put the patient at a significant risk or may confound the study results or may interfere significantly with the patient’s participation in the study as judged by the investigator 11. Current alcohol or drug abuse 12. Current participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the last 30 days
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 are switched from travoprost 0.004% eye drops with preservative to tafluprost 0.0015% eye drops without preservative.;Secondary Objective: ;Primary end point(s): - Change from screening in ocular symptoms upon non-instillation at week 12 - Change from screening in ocular signs at week 12 | — |
Countries
Germany
Outcome results
None listed