Observation clinical registry study to evaluate safety and efficacy of 0.5% carboxymethylcellulose in dry eye disease patients
- Conditions
- Health Condition 1: H00-H59- Diseases of the eye and adnexa
- Registration Number
- CTRI/2020/10/028479
- Lead Sponsor
- Amanta Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 315
1.Patients who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
2.Patients having moderate to severe symptoms suggestive of dry eye wherein the study product would be prescribed by Investigator as part of standard of care.
3.Patients who have been prescribed study product by Investigator as part of standard of care (SOC) practice and consent has been provided by patient post prescription of study product on the same day.
Exclusion Criteria:
1.Patients having any ocular diseases (corneal abrasion, ocular infection, foreign body trapping or ocular trauma), present or past, other than dry eye
2.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
3.Patients using contact lens or topic treatments other than tear substitutes
4.History or active signs of ocular trauma, ocular infection, or ocular inflammation within the last 3 months
5.History or active signs of ocular allergic disease or ocular herpes within the last year
6.Patients participating in any another clinical trial during study
7.Pregnant/lactating women during study period.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to evaluate the safety and efficacy of 0.5% Carboxymethylcellulose Eye Drops in real world all comers population <br/ ><br> <br/ ><br>Timepoint: Baseline, Day 15 and Day 35 <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method ot applicableTimepoint: Not applicable