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Evaluation of 0.3% Motugivatrep Ophthalmic Suspension on Visual Function and Soft Contact Lens in Patients with Dry Eye

Evaluation of 0.3% Motugivatrep Ophthalmic Suspension on Visual Function and Soft Contact Lens in Patients with Dry Eye - Evaluation of 0.3% Motugivatrep Ophthalmic Suspension on Visual Function and Soft Contact Lens in Patients with Dry Eye

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000061171
Enrollment
30
Registered
2026-04-06
Start date
2026-04-06
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Myopia / Dry Eye

Interventions

None listed

Sponsors

Yukoukai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients aged 18 to 40 at consenting 2.Patients capable of providing written informed consent by their own free will 3.Patients who meet the diagnostic criteria for dry eye (BUT: 5 seconds or less, with subjective symptoms) and have been prescribed ophthalmic Motugibatrep suspension during routine medical care 4.Patients who routinely wear bi-weekly replacement SCLs (spherical) in both eyes (6 hours or more per day, 5 days or more per week) 5.Patients with visual acuity of 0.8 or higher while wearing SCLs 6.Patients capable of properly performing SCL care, such as cleaning 7.Patients whom the physician judges can be appropriately evaluated for the efficacy and safety of this study

Exclusion criteria

Exclusion criteria: 1.Patients wearing multifocal or astigmatism-correcting SCLs 2.Patients wearing colored SCLs 3.Patients who have used other dry eye medications* within 14 days before consenting *Patients who have used artificial tears can be registered. 4.Patients with corneal erosions requiring treatment, or patients with punctal plugs inserted 5.Individuals requiring a legal representative 6.Individuals with other conditions that the responsible investigator or subinvestigator deemed unsuitable for participation in the study

Design outcomes

Primary

MeasureTime frame
Mean change in visual acuity from baseline to week 4 after initiation of wearing SCLs

Secondary

MeasureTime frame
1.Mean change in contrast sensitivity from baseline to week 4 2.Mean change in the DEQS symptom score (6 items) from baseline to week 4 3.Mean change in the J-CLDEQ-8 from baseline to week 4 4.Mean change in BUT from baseline to week 4 5.Mean change in corneal staining score using National Eye Institute (NEI)/Industry Workshop grading scale from baseline to week 4 6.Mean change in conjunctival staining score using van Bijsterveld score from baseline to week 4 7.Physical properties of SCLs at week 2 (compared to unused lenses) 1)Shape and appearance 2)Diameter 3)Base curve 4)Vertex power 5)Thickness 6)Optical transmittance 7)Water content 8.Frequency and severity of each adverse event

Countries

Japan

Contacts

Public ContactKoh Shizuka

Yukoukai General Hospital Ophthalmology

cizciz@gmail.com072-641-2488

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026