A post market clinical follow up study of Sterile Hydroxy Propyl Methyl Cellulose Eye Drops
- Conditions
- Health Condition 1: H579- Unspecified disorder of eye and adnexa
- Registration Number
- CTRI/2024/02/062930
- Lead Sponsor
- Amanta Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 65
Subjects who are able to give voluntary, written informed consent to participate in this study.
Subjects who experience as eye dryness, eye soreness/ burning, irritative sensation, eye fatigue, contact lens caused dryness, discomfort of eyes due to the continuous use of computer/ TV/ exposed pollution/ dry environment.
Anyone with known allergic reaction to Sterile Hydroxy Propyl Methyl Cellulose Eye Drops.
Subjects with existing eye infection.
History of ocular surgery. History or active signs of severe or serious ocular conditions such as inflammatory corneal ulcers, recurrent erosions, and uveitis at any time
Patients participating in any another clinical trial during study
Pregnant/lactating women during study period.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective will be, to confirm clinical safety and performance of the product Sterile Hydroxy Propyl Methyl Cellulose Eye Drops from the baseline with follow up visits. <br/ ><br>Timepoint: 1st Visit - After 8 days of using the product <br/ ><br>2nd Visit - After one month of using the product <br/ ><br>3rd Visit - After two months of using the product <br/ ><br>4th Visit - After three months of using the product <br/ ><br>
- Secondary Outcome Measures
Name Time Method The secondary objective will be to assess clinical benefits, contraindications and possible misuse/ off-label use during the use of the product. Also, the continued acceptability of benefit-risk ratio will be ensured during the study. Overall subject and PI satisfaction will be recorded in the case report form.Timepoint: 1st Visit - After 8 days of using the product <br/ ><br>2nd Visit - After one month of using the product <br/ ><br>3rd Visit - After two months of using the product <br/ ><br>4th Visit - After three months of using the product