Effectiveness study on mild to moderate dry eye disease

Relief of dry eye symptoms with Systane Hydration PF in mild to moderate dry eye disease; an effectiveness study. - NIL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/05/110631

Enrollment

Registered

2026-05-19

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Health Condition 1: H049- Disorder of lacrimal system, unspecified

Interventions

Intervention1: Systane Hydration PF: Symptom relief for dry eye, one month is the study duration, route of adminstration is topical,one to 2 drops twice a day Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects greater than 18 years of age both gender 2. Mild to moderate dry eye as evaluated from OSDI-6 Score 4-8 3. NIBUT less than 10secs in both eyes

Exclusion criteria

Exclusion criteria: 1.Severe dry eye disease 2.Any ocular condition that, in the opinion of the Investigator, could affect study parameters like active ocular infection, inflammation, trauma, blepharitis etc. 3.Unwilling to refrain from contact lens use for the entire duration of this study. 4.Contact lens wear in the last week prior to study enrollment (1 week washout period for habitual contact lens users) and on the duration of the study 5.Any significant illness that could interfere with study parameters or the tear film. 6. History of any other ocular surgical procedure within 3 months. 7.Subject with known allergy or hypersensitivity to the components of the formulation 8. Pregnant or breastfeeding women

Design outcomes

Primary

Measure	Time frame
Mean change in dryness symptoms as captured by Dry eye symptom now question (VAS) at 6hrs, after single dose on Day 1Timepoint: 6 hrs, 8 hrs, 10 hrs for day 1, and Day 30	—

Secondary

Measure	Time frame
1.Mean change in dryness symptoms as captured by Dry eye symptom now question on VAS at 8hrs and 10hrs after single dose on Day 1 2.Mean change in dryness symptoms as captured by Dry eye symptom now question on VAS at 6hrs on Day 30 3.Mean change in non-invasive tear break up time (NITBUT) at 6 hrs on Day 30 4.Mean change in Ocular Surface Disease Index (OSDI-6) from baseline to 1 month. 5.Ocular Surface Staining from baseline to 1 month Timepoint: Base Line, Day 30	—

Measure

Time frame

1.Mean change in dryness symptoms as captured by Dry eye symptom now question on VAS at 8hrs and 10hrs after single dose on Day 1 2.Mean change in dryness symptoms as captured by Dry eye symptom now question on VAS at 6hrs on Day 30 3.Mean change in non-invasive tear break up time (NITBUT) at 6 hrs on Day 30 4.Mean change in Ocular Surface Disease Index (OSDI-6) from baseline to 1 month. 5.Ocular Surface Staining from baseline to 1 month Timepoint: Base Line, Day 30

—

Countries

India

Contacts

Public ContactDrPragnya Rao

L V Prasad Eye Institute

drpragnyarao@lvpei.org9618955197

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026