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Observational Clinical Registry to Evaluate Safety and Efficacy of 0.9% Sodium Chloride Eye Wash in all comers real-world population

: Post Marketing, Single Arm, Observational Clinical Registry to Evaluate Safety and Efficacy of 0.9% Sodium Chloride Eye Wash in all comers real-world population - Not applicable

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/10/028708
Enrollment
188
Registered
2020-10-28
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: Inclusion Criteria: 1. Patients above >=18 years of age. 2. Patients who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained. 3. Patients having moderate to severe symptoms suggestive of conditions such as irritation, discomfort, burning, stinging and itching due to loose foreign material in the eyes wherein the study product would be prescribed by Investigator as part of standard of care. 4. 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 3. Patients using contact lens or topic treatments other than tear substitutes 4. History of intolerance or hypersensitivity to any component of the study medications 5. Patients participating in any other clinical trial during study 6. Pregnant/lactating women during study period.

Design outcomes

Primary

MeasureTime frame
The primary objective of this study is to evaluate the efficacy and safety of 0.9% sodium chloride eye wash in real world patients.Timepoint: Baseline and day 10

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactRajdeep Patel

Lal Hospital

sumit_rastogi_1977@yahoo.com

Outcome results

None listed

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