Health Condition 1: H28- Cataract in diseases classified elsewhere
Conditions
Interventions
Intervention1: HPMC Ophthalmic Solution: Eye drops Soothes and gives comfort to the eyes.
It is recommended to use one or two drop into the eye (or eyes) affected by dryness. Many people find it is su
Sponsors
STERICON PHARMA PRIVATE LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: At the time of screening and usage of the product all subjects must meet the following criteria for inclusion into the study and the subjects will receive the prescribed eye drops from the PI/CO-PI by a medical practitioner. The inclusion criteria for the subjects for this study are as follows: -Subjects who experience dryness, Itchiness, discomfort of eyes due to the continuous use of computer/TV/exposed pollution/dry environment -Subjects wearing contact lenses who experience dryness, Itchiness, discomfort of eyes due to the continuous use of computer/TV/exposed pollution/dry environment
Exclusion criteria
Exclusion criteria: The below Subjects are excluded from the study: -Subjects who are not willing to participate in the study -Anyone with known allergic reaction to HPMC eye drops -Subjects with existing eye infection -Subjects undergone recent (6 weeks) cataract surgery who are on other eye medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to confirm clinical safety and performance of the product Hypromellose Ophthalmic Solution (eye drop) by performing a set of eye examinations (i.e. -visual acuity test, IOP measurement, corneal staining, TBUT test, Schirmers test) considering the baseline from the initial visits and data obtained from the follow up visits. If the end user is a contact lens wearer contact lens characteristics will also be measured at the end of the study.Timepoint: Subjects will be followed-up for 4 times after the product use which is on Day 8th, Day 30th, Day 60th and Day 90th. At every follow up visit screening test, comprehensive eye examination by the Investigator will be performed and apart from these tests the product performance, safety, benefits, risks, satisfaction, changes observed in the eye dryness, side effects, and adverse device effect will be checked by asking the quantitative questions from the case report form. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective is to assess any emerging undesirable events along with monitoring of desired events, contraindications, residual risk, emerging risk under normal usage of the eye drops for prolonged period to ensure acceptability of benefit risk ratio of the Eye drop, which will be recorded in CRF during every follow up visit based on the subject rating. The study will be focused on identifying possible systematic misuse or off-label use of the device.Timepoint: Subjects will be followed-up for 4 times after the product use which is on Day 8th, Day 30th, Day 60th and Day 90th. At every follow up visit screening test, comprehensive eye examination by the Investigator will be performed and apart from these tests the product performance, safety, benefits, risks, satisfaction, changes observed in the eye dryness, side effects, and adverse device effect will be checked by asking the quantitative questions from the case report form. | — |
Countries
India
Contacts
Public ContactDr Chethan S Sadanand
Vivekananda Eye Hospital,Bengaluru, Karnataka
Outcome results
None listed