Ocular surface analysis in dry eye patients associated with meibomian gland dysfunction treated with preservative-free 3% diquafosol

Ocular Surface Analysis in Dry Eye Patients Associated with Meibomian Gland Dysfunction

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260417008

Enrollment

Registered

2026-04-17

Start date

2026-04-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Evaporative Dry Eye Disease Meibomian Gland Dysfunction Dry Eye Syndromes Meibomian Gland Dysfunction Diquafosol Ocular Surface Tear Film Lipid Layer Thickness

Interventions

Preservative-free 3% diquafosol ophthalmic solution will be administered as one drop in each eye four times daily for 60 days in patients diagnosed with evaporative dry eye disease associated with mei

Experimental Drug

Preservative-free 3% Diquafosol Ophthalmic Solution

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Adults aged 18 years or older 2.Clinical diagnosis of evaporative dry eye disease associated with meibomian gland dysfunction 3.Presence of dry eye symptoms with OSDI score indicating dry eye disease 4.Ability and willingness to comply with study procedures and follow up visits 5.Written informed consent obtained before study participation

Exclusion criteria

Exclusion criteria: 1.Active ocular infection or ocular surface inflammation unrelated to dry eye disease 2.History of ocular surgery within the previous 3 months 3.Use of topical ocular medications that may interfere with study outcomes 4.Known hypersensitivity to diquafosol or any component of the formulation 5.Severe ocular surface disease requiring alternative treatment 6.Participation in another clinical study within the previous 30 days

Design outcomes

Primary

Measure	Time frame
1.Non-invasive tear break-up time Baseline, Day 30, Day 60 Measured using Oculus Keratograph 5M (Placido ring analysis, average of three measurements),2.Tear meniscus height Baseline, Day 30, Day 60 Measured using integrated digital calipers in Oculus Keratograph 5M,3.Meibography score Baseline, Day 30, Day 60 Meibography imaging using Oculus Keratograph 5M graded according to Arita scale ,4.Conjunctival redness score Baseline, Day 30, Day 60 Objective redness grading using Oculus Keratograph 5M automated analysis,5.Ocular Surface Disease Index Baseline, Day 30, Day 60 Validated 12-item OSDI questionnaire integrated in Oculus Keratograph software,6.Total K5M ocular surface parameters Baseline, Day 30, Day 60 Comprehensive ocular surface analysis using Oculus Keratograph 5M	—

Measure

Time frame

1.Non-invasive tear break-up time Baseline, Day 30, Day 60 Measured using Oculus Keratograph 5M (Placido ring analysis, average of three measurements),2.Tear meniscus height Baseline, Day 30, Day 60 Measured using integrated digital calipers in Oculus Keratograph 5M,3.Meibography score Baseline, Day 30, Day 60 Meibography imaging using Oculus Keratograph 5M graded according to Arita scale ,4.Conjunctival redness score Baseline, Day 30, Day 60 Objective redness grading using Oculus Keratograph 5M automated analysis,5.Ocular Surface Disease Index Baseline, Day 30, Day 60 Validated 12-item OSDI questionnaire integrated in Oculus Keratograph software,6.Total K5M ocular surface parameters Baseline, Day 30, Day 60 Comprehensive ocular surface analysis using Oculus Keratograph 5M

—

Secondary

Measure	Time frame
1.Meibum quality score Baseline, Day 30, Day 60 Korb Blackie grading scale ,2.Lipid layer thickness Baseline, Day 30, Day 60 Measured using LipiView interferometer	—

Countries

Thailand

Contacts

Public ContactPloypak Thanakroekkiat

Department of Ophthalmology, Faculty of Medicine, Thammasat University, Thailand

Th.popoiily@gmail.com0928850738

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026