Health Condition 1: H250- Age-related incipient cataract
Conditions
Interventions
None listed
Sponsors
Department of Pharmaceutical Sciences and Technology Institute of Chemical Technology
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects with immature -Asymptomatic or Symptomatic and uncomplicated cataract not requiring immediate surgery 2. Subjects having diagnosed immature cataract of Grade I II as per LOCS 3 3. Subjects having Best-Corrected Visual Acuity between 6 by 9 and 6 by 36 4. 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 assessment of changes in Lens opacity evaluated on Lenticular Opacity Classification System 3 2.Comparative assessment of change in best corrected visual acuity with autorefractometer findings and quality of vision Timepoint: Screening or Baseline visit, visit 1 (Day 30), visit 2 (Day 60), visit 3 (Day 90), visit 4 (Day 180) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparative assessment of Contrast sensitivity (Pelli-Robson chart) 2. Comparative assessment of grading of visual equity distant vision using Snell sterling s visual scale and logMAR chart 3. Comparative Clinical assessment of symptoms related to cataract on graded scale 4. Comparative Assessment of other changes in eyes related symptoms 5. Global assessment for overall change by subject 6. Global assessment for overall change by the investigator 7. Assessment of tolerability by assessing adverse events 8. Assessment of vitals during the study period Timepoint: Screening or Baseline visit, visit 1 (Day 30), visit 2 (Day 60), visit 3 (Day 90), visit 4 (Day 180) | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd
Outcome results
None listed