Evaluation of symptoms and signs of evaporative dry eye with a lipid-enhanced artificial tear drop

Effect of a propylene glycol-hydroxypropyl guar nanoemulsion in symptoms and ocular surface parameters in patients with evaporative dry-eye

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10208997

Enrollment

Registered

2024-08-16

Start date

2023-09-01

Completion date

Unknown

Last updated

2024-08-26

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

Conditions

Evaporative dry eye Eye Diseases

Interventions

Participants were instructed to instill propylene glycol-hydroxypropyl guar nanoemulsion (Systane Complete) in both eyes three times a day for 90 days.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 18 and 50 years 2. Symptomatic dry-eye disease, according to (Dry eye workshop II) DEWS II criteria

Exclusion criteria

Exclusion criteria: 1. Contact lens wearers 2. Previous ocular surgery 3. History of major systemic or ocular conditions 4. Active ocular inflammation or inflammatory and autoimmune conditions (I.E. ocular cicatricial pemphigoid, Sjögren’s disease) 5. Glaucoma medications or other concomitant use of drops 6. Schirmer’s test <10 mm

Design outcomes

Primary

Measure	Time frame
Dry eye symptoms (Ocular surface disease index questionnaire; OSDI) at baseline, 1 month, and 3 months	—

Secondary

Measure	Time frame
1. Tear break-up time and corneal staining (National Eye Institute scale) were assessed at baseline and at 3 months 2. Osmolarity (measured in mosm/L) was evaluated at baseline and at 3 months using the TearLab Osmometer 3. Lipid layer thickness (categorized as normal/mild/moderate/severe), non-invasive tear break-up time (measured in seconds), and tear meniscus were assessed at baseline and at 3 months using the Keratograph 5M device	—

Measure

Time frame

1. Tear break-up time and corneal staining (National Eye Institute scale) were assessed at baseline and at 3 months 2. Osmolarity (measured in mosm/L) was evaluated at baseline and at 3 months using the TearLab Osmometer 3. Lipid layer thickness (categorized as normal/mild/moderate/severe), non-invasive tear break-up time (measured in seconds), and tear meniscus were assessed at baseline and at 3 months using the Keratograph 5M device

—

Countries

Chile

Contacts

Public ContactCristian Cartes

ccartes@centrodelavision.cl+56 985007180

Outcome results

None listed

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