The aim of this study is to show how well T4030 eye drops work in lowering the high eye pressure and how safe they are, compared to another product, called Ganfort. Controlling eye pressure is a leading way to prevent vision loss in people with ocular hypertension or glaucoma.
- Conditions
- Health Condition 1: H408- Other glaucoma
- Registration Number
- CTRI/2021/04/033213
- Lead Sponsor
- aboratories THEA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 85
1.1. Informed consent signed and dated
Obtained prior the initiation of any procedures
AT SCREENING (Visit #1)
1.2. Patient aged >=18 years old
1.3. Both eyes with a central corneal thickness assessment >=500 µm and <=600 μm assessed within 6 months, or during the screening visit
1.4. Both eyes with diagnosed ocular hypertension or open angle glaucoma (primary open-angle, pseudoexfoliative or pigmentary glaucoma) currently treated with a first-line monotherapy (PGA or beta-blocker), insufficiently controlled in the opinion of the investigator, and requiring a dual therapy (bitherapy)
AT RANDOMISATION VISIT (Visit #2):
1.5. IOP >=22 mmHg in in both eyes at 08:00
1.6. IOP asymmetry between eyes <=4 mmHg at 08:00
1.7. IOP <36 mmHg in both eyes at all time points (08:00, 10:00, 16:00).
1.8. Patient having respected the wash out period of at least 28 days.
Ophthalmic Exclusion Criteria in AT LEAST ONE EYE [2.1]
Patient experiencing at screening visit or having experienced:
2.1.1 Inability to safely discontinue use of IOP-lowering ocular medication for the specified wash-out period according to the investigatorâ??s best judgement
2.1.2 Visual field not available within previous 6 months and not performed at the screening visit
2.1.3 History of narrow angle and/or angle closure glaucoma
2.1.4 Advanced stage of glaucoma defined by at least one of the following criteria:
2.1.4.1 Severe central visual field loss (i.e., sensitivity loss 10 dB or more in at least 2 of the 4 visual field test points closest to the point of fixation)
2.1.4.2 Severe visual field loss: MD <-12 dB
2.1.4.3 Risk of visual field worsening as a consequence of participation in the study according to the investigatorâ??s best judgement
2.1.5 Cup to disk ratio >0.8 (horizontal or vertical measurement)
2.1.6 Known history of non-response to bimatoprost and/or timolol
Patient experiencing at Screening or Randomisation visits or having experienced:
2.1.7 Far Best Corrected Visual Acuity >=0.7 LogMar (e.g., <=0.2 in decimal value or <=20/100 Snellen equivalent or <=50 ETDRS letters)
2.1.8 History of trauma, infection or clinically significant inflammation within the previous 3 months
2.1.9 Ongoing or known history of uveitis and/or viral infection
2.1.10 Ongoing ocular allergy
2.1.11 Clinically significant or progressive retinal disease (e.g. para-/central retinal degeneration, diabetic retinopathy, retinal detachment)
2.1.12 Presence of at least one severe objective sign among the following:
2.1.12.1 Conjunctival hyperaemia Grade 5 on the McMonnies scale
2.1.12.2 Corneal fluorescein staining (CFS) Grade 4 or 5 on the Oxford grading scale
2.1.12.3 Severe Blepharitis Score 3 using a 0-3 scale
2.1.13 Presence of severe dry eye as assessed by the investigator
2.1.14 Presence of corneal ulceration
2.1.15 Presence of palpebral abnormalities incompatible with a good examination
2.1.16 Any other abnormality preventing accurate assessment and/or clinically significant ocular disease, which could potentially deteriorate during the study e.g. reliable applanation tonometry measurement, visual field assessment, fundus examination
Systemic/non-Ophthalmic Exclusion Criteria [2.2]
Patient experiencing at Screening or Randomisation visits:
2.2.1 Uncontrolled diabetes
2.2.2 Overt cardiac failure, cardiogenic shock
2.2.3 Sinus bradycardia, sick sinus syndrome, sino-atrial block, second- or third-degree atrioventricular block not controlled with pace-maker
2.2.4 Heart rate <50 bpm and/or systolic arterial blood pressure <=90 mmHg
2.2.5 Presence or history of reactive airway disease (e.g bronchial asthma or severe chronic obstructive pulmonary disease)
2.2.6 Known or suspected hypersensitivity to one of the components of the IMP(s) (T4030, Ganfort® UD) or fluorescein and/or oxybuprocaine hydrochloride
2.2.7 Any other history of, or active relevant systemic condition incompatible with the study or likely to interfere with the study results or the patient safety according to investigatorâ??s judgement
Specific Exclusion Criteria Regarding Ch
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method