Clinical trial on dry eye patients

Analysis of comparative efficacy of a combination formula for a lubricant (Trehalose with sodium hyaluronate 1mg/mL) in the management of ocular surface conditions

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/01/011121

Enrollment

Registered

2018-01-03

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: null- Mild to moderate dry eye disease Health Condition 2: H100- Mucopurulent conjunctivitis

Interventions

Intervention1: Trehalose with sodium hyaluronate 1mg/mL: Drug will give after enrolled study 10 days and follow up with 1 month, 3 Months and 6 Months Dose: 1mg/mL Route: eye drops frequency: 6 time

Eligibility

Inclusion criteria

Inclusion criteria: 1.Males and Females 2.Age 18 to 65 years, 3.Mild to moderate dry eye disease as per: i.OSDI score >18 ii.Schirmers II (with anaesthesia) >5 at 5 minutes, iii.TBUT iv.Corneal and conjunctival staining ( graded by NEI and Van Bjisterveld grading) 4.No use of any tear substitute for either eye in the preceding 6 weeks 5.Willing to participate in the study Inclusion criteria for Arm 2: 6.All patients undergoing corneal refractive surgery without pre-existing dry eye 7.Willing to participate in the study

Exclusion criteria

Exclusion criteria: 1.BCVA distance 2.Severe blepharitis 3.Eyelid malposition 4.Corneal scar/ opacity 5.Ocular Surface Squamous neoplasia (OSSN) 6.Corneal neovascularisation or pannus 7.cular allergy (except in paediatric population) 8.Any ocular infection in the past 3 months 9.Cataract surgery in the past 3 months 10.Corneal or conjunctival procedure 11.Ocular medications which are known to worsen dry eye like AGM 12.Systemic conditions like collagen vascular disease, rheumatoid arthritis, Steven Johnson syndrome Exclusion criteria for arm 2 13.Pre-existing dry eye 14.Corneal neovascularisation or pannus 15.Ocular allergy (except in paediatric population) 16.Any ocular infection in the past 3 months

Design outcomes

Primary

Measure	Time frame
1.The changes in various ocular surface signs and symptoms and quantitative and qualitative analysis of tear film in dry eye induced secondary to laser refractive surgery and effect of various topical eye medications on it Timepoint: 10 days, 1 month, 3 months and 6 months	—

Secondary

Measure	Time frame
To study the inflammatory pathways involved in dry eye and action of each of the medications on those pathwaysTimepoint: 6 Months	—

Countries

India

Contacts

Public ContactDr Sriharsha Nagaraj

Narayana Nethralaya

arkasubhra@narayananethralaya.com

Outcome results

None listed

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