Subjects who have subjective symptoms of ocular dryness and also experience eye fatigue or blurred vision. In addition, among soft contact lens wearers, those who feel discomfort while wearing contact lenses are included.
Conditions
Interventions
Over 2weeks
Sponsors
ROHTO pharmaceutical CO.,LTD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Subjects who meet all of the following criteria 1)-4) for both eyes at the screening visit: 1)Subjects who have subjective symptoms of eye dryness (score >= 1) 2)Subjects who have subjective symptoms of eye fatigue or blurred vision (score >= 1) 3)Subjects who feel discomfort while wearing contact lenses [applicable only to soft contact lens wearers] (score >= 1) 4)Subjects who habitually wear soft contact lenses (5 days or more per week) [applicable only to soft contact lens wearers] (2) Subjects whose mean scores for both eyes during the 3 days prior to the start of study drug administration are >= 1.0 for all of the following symptoms: -Eye dryness -Eye fatigue or blurred vision -Discomfort while wearing contact lenses [applicable only to soft contact lens wearers]
Exclusion criteria
Exclusion criteria: (1) Subjects whose tear film break-up time (BUT) in either eye or both eyes is <= 5 seconds at the screening visit. (2) Subjects who have used over-the-counter (OTC) artificial tears within 3 days prior to the start of study drug administration. (3) Subjects who have used any ophthalmic preparations (excluding OTC artificial tears) or ophthalmic ointments within 7 days prior to the start of study drug administration. (4) Subjects who have used corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or other medications for ophthalmic diseases (both are administered systemically and topically to the head or face, including nasal and ear drops) within 7 days prior to the start of study drug administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the score of the subjective symptom "eye dryness" | — |
Countries
Japan
Contacts
Public ContactYusuke Takeuchi
ROHTO pharmaceutical CO.,LTD Pharmaceutical Clinical Development Division
Outcome results
None listed