MSCR has a network of experienced ophthalmologists who have conducted numerous ophthalmological safety and efficacy studies.
Phase I:
Safety assessment after evaluating the following parameters on normal, healthy volunteers.
Primary outcome measures: AEs, Ocular Comfort Index
Secondary outcome measures: Visual acuity, Epithelial defects - Fluorescein stain, green lissamine, conjunctival hyperemia, chemosis.
Phase II:
Safety and efficacy on a small population to evaluate and investigate the treatment effect on subjects with defined conditions.
Phase III:
Benchmark controlled safety and efficacy study on subjects with defined conditions.Large sample sizes.
These studies are designed in a scientific and robust manner and include ophthalmological examinations with a standard/ published scale along with instrumental imaging and high quality imaging to record visible differences. The study may also be combined with biological sample collection and analysis as required.
Subjects with the following ophthalmological conditions can be recruited
Age-related macular degeneration
Geographic atrophy
Blepharitis-15-20 per month
Cataract lenses- 20-25 per month,
Conjunctivitis[ viral/ bacterial/ non specific/infective/ allergic/ non-infective] Such as Ocular adenovirus infection
Contact lens solutions: Quality, tolerance and comfort
Diabetic macular oedema
Dry eye- clinical examination, quality and quantity of tear/ Intraocular lenses
Post-cataract surgery maintenance
Sjorgen’s syndrome
Glaucoma
Ocular burns- chemical injury
Corneal foreign body
Retinitis pigmentosa
Uveitis
Vitreous implants-costly implants [ A corrective treatment for diabetic macular edema]
Diabetic retinopathy
Acanthamoeba keratitis- Mostly seen in, contact lens users
Ethics Committee
Study Management Services
- Scientific Consultation
- Protocol Development
- Medical Writing
- Comprehensive Project Management
- Multicentric Study Coordination and Management
- Clinical Monitoring
- Medical Monitoring
- Data Management
- Biostatistics
- Reporting
