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A study to test whether a new eye drop bottle design provides better relief from dry eyes

Hydra-Eye-Lixir: Hydration that sees you through the day - Evaluating the efficacy of a Novel Lacrimomimetic as an innovative solution for tear film insufficiency - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/086587
Enrollment
120
Registered
2025-05-08
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Health Condition 1: H048- Other disorders of lacrimal system

Interventions

Intervention1: Carboxymethyl Cellulose: 0.5 percentage QID for 1 year in a single drop dispensing device Control Intervention1: Carboxymethyl Cellulose: 0.5 percentage QID for 1 year in commercially a

Sponsors

Dr Smriti Sarathi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Participants must have a confirmed diagnosis of dry eye syndrome based on clinical evaluations, such as the Schirmer s test and patient-reported symptoms. 2.Participants aged 16 years and older who can use the eye drops independently. 3. Participants must provide written informed consent to participate in the study. 4.Participants should be able to follow the study protocol, including completing questionnaires and attending follow-up visits.

Exclusion criteria

Exclusion criteria: 1.Individuals who have undergone ocular surgery (e.g., cataract surgery, LASIK) within the last 6 months. 2.Participants currently using other prescription eye drops or medications that may interfere with the study outcomes. 3.Presence of other severe ocular conditions (e.g., severe allergic conjunctivitis, corneal ulcers) that could confound the results. 4.Individuals with systemic diseases affecting tear production (e.g., Rheumatoid Arthritis) that are not stable or well-controlled. 5.Known allergies to carboxy methyl cellulose or other components in the formulation.

Design outcomes

Primary

MeasureTime frame
dry eye reliefTimepoint: 1 year

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDr Smriti Sarathi

Saveetha Medical College and Hospital

divya.q7@gmail.com7299933288

Outcome results

None listed

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