A clinical trial on the changes in ocular signs and symptoms in patientswith ocular hypertension or open-angle glaucoma switched from Ganfort® eye drops to Taptiqom® eye drops.

Phase 1

Conditions: Glaucoma or Ocular Hypertension
MedDRA version: 18.0Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disorders
MedDRA version: 18.0Level: PTClassification code 10030348Term: Open angle glaucomaSystem Organ Class: 10015919 - Eye disorders
MedDRA version: 18.0Level: PTClassification code 10074026Term: Exfoliation glaucomaSystem Organ Class: 10015919 - Eye disorders
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2014-005273-37-DE

Lead Sponsor: Santen Oy

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br><br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): Change from screening in ocular signs at week 12 (other than conjunctival redness/hyperemia)<br><br>Change from screening in ocular symptoms upon non-instillation at week 12<br><br>Quality of Life ;Timepoint(s) of evaluation of this end point: At 12 weeks

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