Eyestrain Eye pain
Conditions
Interventions
This study is a specific clinical trial designed to evaluate the efficacy and safety of 0.025% cyclopentolate ophthalmic solution when administered to both eyes during a two-week treatment period. It
0.025% cyclopentolate ophthalmic solution, RCT
Sponsors
Kinoshita Shigeru
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Answer a questionnaire regarding subjective symptoms related to eyestrain. 2) Diagnosis of eyestrain. 3) Aged 18 years or older but under 65 years, regardless of gender. 4) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Individuals with risks to increased intraocular pressure, such as glaucoma, narrow angle, or shallow anterior chambers in either eye. 2) Individuals with a history of allergy or severe adverse reactions to cyclopentolate hydrochloride. 3) Individuals with a corrected visual acuity of less than 0.7 in either eye. 4) Individuals who have not corrected refractive errors in either eye according to their daily activities. 5) Individuals with a history of ocular trauma resulting in pupillary or iris deformation in either eye. 6) Individuals with any kind of strabismus. 7) Individuals with diabetes mellitus 8) Individuals who have treated for autonomic failure 9) Individuals who are pregnant, breastfeeding, possibly pregnant, or planning to become pregnant during the study period. 10) Individuals who have undergone ocular surgery within 90 days before the scheduled study start date or are planning to undergo ocular surgery during the study period. 11) Individuals who have participated in another clinical trial (including interventional clinical research) within 90 days before the scheduled study start date or are planning to participate in another clinical trial during the study period. 12) Individuals deemed unsuitable for study participation by the principal investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the total score of subjective symptoms related to eye pain (five items) after 2 weeks of administration (between groups). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change in the total score and individual scores of subjective symptoms after 2 or 4 weeks of administration (between groups and within group). 2) Stability of refractive power in accommodative resting position after 2 or 4 weeks of administration (between groups and within group). | — |
Contacts
Public ContactKojiro Imai
Graduate school, Kyoto Prefectural University of Medicine
Outcome results
None listed