Skip to content

Low Dose Pilocarpine vs Placebo for Migraine Related Disability and Photophobia

A Randomized, Double Masked, Placebo Controlled Investigator Initiated Trial of Low Dose Pilocarpine Ophthalmic Solution for the Management of Migraine Related Disability and Photophobia

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/07/113720
Enrollment
50
Registered
2026-07-08
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Health Condition 1: G439- Migraine, unspecified

Interventions

Intervention1: Low dose pilocarpine in tear substitute: 0.125% pilocarpine ophthalmic solution eye drops twice daily for 3 months Control Intervention1: Tear substitute: Tear substitute eye drops twic

Sponsors

Ruby Moharana
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Participants meeting ICHD 3 criteria for migraine Participants 12 to 40 years old with migraine and photophobia Participants having light as a trigger factor for the migraine attack Participants with best corrected visual acuity 6 by 6 for distance and N6 for near Participants with normal anterior and posterior segments with normal Intraocular pressure Participants voluntarily giving informed consent

Exclusion criteria

Exclusion criteria: Participants with pre existing ocular conditions affecting pupil size Participants with Manifest Refraction Spherical Equivalent worse than four diopters of myopia or greater than two diopters of hyperopia in either eye Participants with recent eye surgeries Participants on any medications which can affect pupil size

Design outcomes

Primary

MeasureTime frame
- Mean change in MMD (Monthly Migraine Days)Timepoint: Baseline, 90 days

Secondary

MeasureTime frame
VAS scores for photophobia and ocular discomfort Timepoint: Baseline, 60 minutes;Photopic Pupil Size in mm by IOL Master 700Timepoint: Baseline, 60 minutes;Tear Break Up time (TBUT)Timepoint: Baseline, 90 days;Headache Impact Test (HIT6) scoresTimepoint: Baseline, 90 days

Countries

India

Contacts

Public ContactRuby Moharana

Apex Eye Care

rubymoharana@gmail.com7428968090

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026