NIPH Clinical Trials Search

low concentration cyclopentolate hydrochloride ophthalmic solution for eyestrain

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Eyestrain
Date of first enrollment	27/02/2026
Target sample size	80
Countries of recruitment
Study type	Interventional
Intervention(s)	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 will be conducted as a multicenter, randomized, placebo-controlled, double-blind, parallel-group comparison study. Next, all subjects will undergo an additional two-week treatment period following the initial treatment phase. 0.025% cyclopentolate ophthalmic solution will be administered to both eyes in this period.

Outcome(s)

Primary Outcome	Change in the total score of subjective symptoms related to eye pain (five items) after 2 weeks of administration (between groups).
Secondary Outcome	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).

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	< 65age old
Gender	Both
Include 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.
Exclude 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.