Appropriate concentration of botulinum toxin type A for dry eye disease treatment by injection into the medial lower eyelid

Appropriate concentration of botulinum toxin type A for the treatment of dry eye disease by injection into the medial lower eyelid

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20221004007

Enrollment

Registered

2022-10-04

Start date

2019-08-29

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

dry eye symptoms persisted with positive corneal fluorescein staining botulinum toxin, dry eye, ocular surface disease

Interventions

Using an online randomization tool, one eyelid was randomly administered a subcutaneous injection of 3.3 U of botulinum toxin type A (Botox

Allergan, Irvine, CA, USA) in the medial part of the lower eyelid, 2 mm inferior to the lid margin, and 5 mm medial to the lower punctum. Complete subjective and objective evaluations were performed

Active Comparator Drug,Active Comparator Drug

3.3 U of botulinum toxin type A ,2.5 U of botulinum toxin type A

Eligibility

Sex/Gender

All

Age

20 Years to No maximum

Inclusion criteria

Inclusion criteria: dry eye patients older than 20 years who had a similar degree of dry eye in both eyes and had received treatment with non-preservative artificial tears for at least 1 month whom dry eye symptoms persisted with positive corneal fluorescein staining

Exclusion criteria

Exclusion criteria: Patients with dry eye attributable to eyelid abnormalities, nasolacrimal duct obstruction, active corneal infection, or a history of botulinum toxin hypersensitivity were excluded.

Design outcomes

Primary

Measure	Time frame
OSDI score (subjective evaluation) 2, 8, 12, and 16 weeks after the intervention ocular surface disease index (OSDI) questionnaire,tear film break-up time (TBUT) 2, 8, 12, and 16 weeks after the intervention. TBUT was defined as the time required for dry spots to appear on the corneal surface after blinking following fluorescein staining, and the mean value of three measurements was recorded.,Schirmer test 2, 8, 12, and 16 weeks after the intervention sterile paper strips were inserted into the inferotemporal aspect of the conjunctival sac for 5 minutes to measure tear production in millimeters (mm).,The modified Oxford grading scheme 2, 8, 12, and 16 weeks after the intervention The modified Oxford grading scheme for corneal and conjunctival staining was used after fluorescein staining, to grade according to severity from 0 (absent) to 5 (severe).	—

Measure

Time frame

OSDI score (subjective evaluation) 2, 8, 12, and 16 weeks after the intervention ocular surface disease index (OSDI) questionnaire,tear film break-up time (TBUT) 2, 8, 12, and 16 weeks after the intervention. TBUT was defined as the time required for dry spots to appear on the corneal surface after blinking following fluorescein staining, and the mean value of three measurements was recorded.,Schirmer test 2, 8, 12, and 16 weeks after the intervention sterile paper strips were inserted into the inferotemporal aspect of the conjunctival sac for 5 minutes to measure tear production in millimeters (mm).,The modified Oxford grading scheme 2, 8, 12, and 16 weeks after the intervention The modified Oxford grading scheme for corneal and conjunctival staining was used after fluorescein staining, to grade according to severity from 0 (absent) to 5 (severe).

—

Secondary

Measure	Time frame
margin reflex distance 2 (MRD-2) 2, 8, 12, and 16 weeks after the intervention Distance between corneal light reflex and lower eye lid margin in millimeters	—

Countries

Thailand

Contacts

Public ContactNattapong Mekhasingharak

Naresuan University,Thailand. 99 Moo 9, Tambon Tha Pho, Muang Phitsanulok 65000, Thailand

buntosi@yahoo.com0860881545

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026