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Observation clinical registry study to evaluate safety and efficacy of 0.5% carboxymethylcellulose in dry eye disease patients

Post Marketing, Single Arm, Observational Clinical Registry to Evaluate Safety and Efficacy of 0.5% Carboxymethylcellulose Eye Solution in real-world population with dry eye disease patients.

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/10/028479
Enrollment
629
Registered
2020-10-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H00-H59- Diseases of the eye and adnexa

Interventions

Intervention1: NIL: NIL

Sponsors

Amanta Healthcare Limited
Lead Sponsor
Eupraxia Centre For Clinical Excellence LLP
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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 Timepoint: Baseline, Day 15 and Day 35

Secondary

MeasureTime frame
Not applicableTimepoint: Not applicable

Countries

India

Contacts

Public ContactRajdeep Patel

Consultant Ophthalmologist

sumit_rastogi_1977@yahoo.com9453294577

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026