Health Condition 1: H472- Optic atrophy
Conditions
Interventions
None listed
Sponsors
Jagat Pharma Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants clinical diagnosis must be consistent with glaucoma characterized by the following features a) Clinical evidence of progressive retinal ganglion cell (RGC) dysfunction and degeneration using both visual field and at least one structural modality as established by Glaucomatous visual field abnormality, Mean deviation (MD) of minus 3 to minus 15 dB and Minimum average retinal nerve fiber layer (RNFL) thickness of 60 micrometer and maximum average RNFL of 90 micrometer. b) Residual visual field preservation including best corrected visual acuity (BCVA) better than 20 by 200 in both eyes. c) Two visual field tests of adequate quality with a maximum visual field index (VFI) variability of plus or minus 10 percent 3. Participants glaucoma must be clinically stable, with intraocular pressure (IOP) greater than 21. 4. If a participant has two eyes meeting study criteria, only the worse eye as determined by visual field index (VFI) will be deemed includable. If both eyes qualify and have the same VFI, a randomization procedure will assign one eye to the study. 5. Subjects willing to sign informed consent and to undergo all the study
Exclusion criteria
Exclusion criteria: 1. Subjects with Pre-existing multiple sclerosis MS or NMO. 2. Subjects with Refractive media opacity. 3. Subjects with Hyperopia greater than 5 diopters, myopia less than-5 diopters, or astigmatism greater than 3 diopters. 4. Subjects with known Active tuberculosis, hepatitis, renal insufficiency, uncontrolled hypertension, diabetes mellitus, infection with HIV or syphilis, or any other conditions potentially interfering treatment trial. 5. Subjects with other autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, etc). 6. Subjects with existing other retina or optic nerve diseases. 7. Subjects who have taken corticosteroids in the last 30 days for optic neuritis. 8. Pregnant or females who plan to be pregnant during study. 9. Subjects having known allergic reaction to ingredients of Isotine GI eyedrop and capsule Iso Neuron. 10. Breast feeding females. 11. Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparative change in Global retinal nerve fibre layer thickness (RNFLT-G) as assessed using Optical Coherence Tomography (OCT)Timepoint: Screening visit, day 90 and day 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparative change in total macular volume assessed using Optical Coherence Tomography (OCT) 2. Comparative change in best corrected visual acuity (BCVA) 3. Comparative change in visual field (Visual Field Index (VFI), Mean Deviation (MD) and Pointwise linear regression (PLR)) as assessed using Humphreys Visual field (HVF) Analyzer 4. Comparative change in contrast sensitivity 5. Global assessment for overall change by investigator and subject on CGI Scale 6. Assessment of tolerability of study drugs by investigator and subject. 7. Adverse events and vitals Timepoint: Screening visit, day 90 and day 180 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd
Outcome results
None listed