Dry Eye, Photophobia
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients meeting the diagnostic criteria for dry eye disease. 2.Patients presenting with photoallodynia or ocular pain above a pre-specified threshold on the NRS or VLSQ-8. 3.Patients who understand the purpose of the study and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.Glaucoma patients requiring two or more topical anti-glaucoma medications (Note: Patients well-controlled with a single agent are permitted). 2.Patients with active intraocular inflammation, such as active uveitis or severe allergic conjunctivitis. 3.Patients with moderate-to-severe cataract causing decreased visual acuity (Note: Mild cataract and pseudophakia [IOL] are permitted and will be treated as covariates in the analysis). 4.Other patients deemed inappropriate for study participation by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NRS (Numeric Rating Scale): Assessment of ocular pain and light-induced pain (scale of 0-10). VLSQ-8 (Visual Light Sensitivity Questionnaire-8): Assessment of photophobia-related quality of life. Safety and Tolerability: NRS assessment of instillation-site irritation (e.g., cooling or burning sensations). | — |
Secondary
| Measure | Time frame |
|---|---|
| Tear Meniscus Height (TMH): Non-invasive quantification using anterior segment OCT (CASIA2). Corneal epithelial damage: NEI scale (range, 0-15 points). Conjunctival damage: van Bijsterveld score (range, 0-9 points). Tear Break-Up Time (TBUT): Assessment via fluorescein staining. Covariates: Lens status (presence of cataract or intraocular lens), along with baseline TMH and vital staining scores. | — |
Countries
Japan
Contacts
Tokyu Hospital Ophthalmology