Open Angle Glaucoma
Conditions
Brief summary
This is a randomized, parallel arm, multicenter, double-blind trial. Patients with POAG will be randomized 1:1 ratio to receive: * Prostaglandin analogue (PGA) monotherapy + CoQun® (Arm A) * Prostaglandin analogue (PGA) monotherapy + Vehicle (Arm B)
Detailed description
CoQun® 10 ml is a medical device marked by the European Community as class IIb. This device has a system of dispensation that permits it to be preservative free (OSD - Ophthalmic Squeeze Dispenser). Investigators and patients will be masked to the study treatment. In order to mask the treatment, identical kit boxes, identical packaging (bottles and labels) will be used for vehicle and active product. The bottles will be dispensed sealed to the patient. One or two drops of the solution (CoQun® or Vehicle) will be instilled in the conjunctival sac of both eyes, twice daily from 8 to 10 AM and from 8 to 10 PM. Hypotensive therapy should be administered in the evening one hour after the CoQun® or Vehicle administration. At baseline, ocular hypotensive treatment, as per inclusion criteria has to be a PGA monotherapy. During the follow-up, in case the IOP exceeds 28 mmHg, any additional hypotensive therapy will be allowed to obtain IOP control. Dose modifications/reductions of CoQun® /Vehicle are not permitted.
Interventions
DEVICECoqun® ophthalmic solution
Prostaglandin analogue (PGA) monotherapy + Coqun® ophthalmic solution
OTHERPlacebo ophthalmic solution
Prostaglandin analogue (PGA) monotherapy + Placebo ophthalmic solution
Sponsors
Mario Negri Institute for Pharmacological Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
Double blind study
Eligibility
Sex/Gender
ALL
Age
40 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with diagnosis of POAG (monolateral or bilateral) with an IOP ranging from 17 to 21 mm Hg (at the last performed visit and confirmed at the baseline study visit) on treatment with a topical prostaglandin analogue (PGA) monotherapy. 2. VF examination at randomization: VF Mean Defect (MD) at baseline within -4 decibel (dB) and -10dB and VF Pattern Standard Deviation (PSD) within 4 dB and 10dB (stage 2-3 per the Enhanced Glaucoma Staging System 2 (GSS) determined by Humphrey Field Analyzer II-i, program 30-2 SITA standard. 3. In order to determine patient's reliability to perform VF examination: before baseline VF, at least two reliable VF examinations during the last year had to be performed. Visual fields are considered reliable if false-positive responses are fewer than 15% and a clear blind spot could be seen in the VF printouts, threshold value \<10 dB. 4. Age \>40 years 5. Provision of informed consent prior to any study specific procedures
Exclusion criteria
1. Secondary glaucoma (exofoliative glaucoma, pigmentary glaucoma, neovascular glaucoma). 2. Abnormalities of the anterior segment of the eye that could affect IOP assessment. 3. Cornea abnormalities with entities that could affect IOP evaluation. 4. Other conditions different from glaucoma that could cause VF abnormalities (degenerative myopia, diabetic retinopathy, maculopathy, other optic nerve abnormalities that could mimic glaucoma damage). 5. BCVA) \< 0.5 Snellen decimal fraction 6. Any previous ocular surgery except for uncomplicated cataract extraction and YAG laser capsulotomy, laser glaucoma surgeries (argon laser trabeculoplasty and/or selective laser trabeculoplasty). 7. Pregnancy or breast-feeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Progression (TTP) | Randomization till VF progression, up to 36 months | Time to Progression (TTP) defined as the time between baseline visit and the visit with the first evidence of progression in either eye is detected. When progression is detected, the progression should be confirmed at the two subsequent and consecutive Visual Field (VF) examinations.VF examinations will be assessed by an independent reading centre. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Velocity of Visual Field (VF) loss | Randomization till VF progression, up to 36 months | VF loss as determined by Guided Progression Analysis software (version 5.1.1) will be assessed at the last VF examination. |
| Retinal Nerve Fiber Layer (RNFL) thickness | Randomization till VF progression, up to 36 months | RNFL thickness by the means of OCT: change from baseline |
| Intraocular pressure (IOP) | Randomization till VF progression, up to 36 months | IOP change from baseline |
| Best Correct Visual Acuity (BCVA) | Randomization till VF progression, up to 36 months | BCVA change from baseline |
Countries
Italy
Outcome results
None listed