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To study the effects of the Systane COMPLETE eye drops in the treatment of dry eye disease in diabetic patients

Improvement In Health-Related Quality Of Life (HRQOL) in diabetic patients with dry eye after using Systane Complete - NA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/052501
Enrollment
58
Registered
2023-05-11
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

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: Propylene glycol USP 0.6% W/V Lubricant Eye Drops Systane COMPLETE: Dry eye disease treatment,1 drop (30microlitre) 4times/day for 1 month via ocular cul-de-sac Control Intervention1: N

Sponsors

Alcon Laboratories Ind Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diabetic subjects between 18-55 yrs, who present to hospital with symptoms of dry eye and having Ocular Surface Disease Index (OSDI) score between 13-32

Exclusion criteria

Exclusion criteria: 1.Subjects already diagnosed with dry eyes secondary to any other cause. 2.Subjects diagnosed to have severe dry eye 3.Subjects who have undergone previous ocular surgery. 4.Subjects who are on treatment with other Artificial tear products or previously diagnosed with other ocular pathologies. 5.Subjects who have used contact lenses within the last 6 months

Design outcomes

Primary

MeasureTime frame
Improvement in symptom scoreTimepoint: 1 MONTH

Secondary

MeasureTime frame
Improvement in tear film parameters (Schirmerâ??s, NIBUT, Corneal staining scores and keratograph)Timepoint: 1 MONTH

Countries

India

Contacts

Public ContactDr Rachapalle Reddi Sudhir

Ophthalmologist, Sankara Nethralaya

drrrs@snmail.org

Outcome results

None listed

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