Health Condition 1: H259- Unspecified age-related cataract
Conditions
Interventions
Intervention1: Isotine Plus I Drop: Contains Jeevanti, Amla, Palash, Chandan, Apamarg, Fennel, Punarnava, Bhringraj, Arjuna, Satva Podina
Dosage and Treatment Duration: Subjects will be advised to pu
Sponsors
Jagat Pharma Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects with immature (Asymptomatic or Symptomatic) and uncomplicated cataract not requiring surgery 2. Subjects having cataract with possible grading on slit lamp bio microscopy according to Lenticular Opacity Classification System II. 3. Subjects who are ready to provide written informed consent and who are ready to willingly participate and follow the protocol requirements of the clinical study.
Exclusion criteria
Exclusion criteria: 1. Subjects with congenital cataract, mature and hyper mature cataract 2. Subjects having any other ophthalmic condition like glaucoma, diabetic retinopathy, macular degeneration, retinitis pigmentosa which requires urgent and separate treatment 3. Subjects with Uncontrolled Diabetes and Uncontrolled Hypertension 4. Subjects taking Steroid treatment and or any kind of immunosuppressive therapy 5. Subjects participating in any other clinical study or having participated in any other study 3 months prior to screening in the present study. 6. Subjects who are in general sensitive to any eye drops 7. A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout study period 8. Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Comparative changes in lens evaluated on Lenticular Opacity Classification System II and direct and indirect ophthalmoscopy examinations between subjects using Isotine Plus I Drops and those using conventional management 2. Comparative assessment of visual acuity and quality of vision between subjects using Isotine Plus I Drops and those using conventional management Timepoint: Day -3, Day 0, Day 30, Day 60, Day 90 and Day 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparative clinical assessment of symptoms related to cataract between two groups 2. Comparative assessment of other changes in eyes related symptoms like itching, tiredness, irritation, burning etc. if any, between two groups 3. Global assessment for overall change by the subject and investigator at the end of 180 days of study treatment between two groups 4. Assessment of tolerability by assessing adverse events 5. Assessment of vitals during the study period Timepoint: Day -3, Day 0, Day 30, Day 60, Day 90 and Day 180 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research
Outcome results
None listed