The efficacy of 0.18% versus 0.3% sodium hyaluronate in the treatment of ocular surface disease in glaucoma patients after trabeculectomy with mitomycin-C: a randomized clinical trial

0.18% versus 0.3% SH in the treatment of OSD in glaucoma patients after trabeculectomy with MMC

Status

Unknown

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20220524003

Enrollment

Registered

2022-05-24

Start date

2022-06-01

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

ocular surface disease in glaucoma patients after trabeculectomy with mitomycin-C ocular surface disease, glaucoma, trabeculectomy, mitomycin-C, sodium hyaluronic acid

Interventions

0.18% sodium hyaluronate eye drop 1 drop every 2 hrs until bedtime,0.3% sodium hyaluronate eye drop 1 drop every 2 hrs until bedtime

Active Comparator Drug,Active Comparator Drug

Drug A,Drug B

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Glaucoma patients, both male and female, age not lower than 18-year-old, and 2) Scheduled to have trabeculectomy with mitomycin-C, (or combined with phacoemulsification), and 3) Has ocular surface disease index (OSDI) score greater than or equal to 20 and/or has one of the following signs 1.Eyelid skin or lid margin inflammation 2.Signs of meibomian gland dysfunction 3.Follicle at tarsal conjunctiva 4.Fluorescein staining score greater than or equal to 3 5.Fluorescein tear breakup time (FBUT) lesser than or equal to 8 sec 6.Schirmer score lesser than or equal to 5 mm

Exclusion criteria

Exclusion criteria: 1) Need pre-operative artificial tear or other modalities to treat dry eye disease 2) Immunocompromised patients 3) Those with known allergies to any ingredient of study medications 4) Pregnant or lactating women 5) Contact lens wear (soft, hybrid or rigid gas permeable contact lenses)

Design outcomes

Primary

Measure	Time frame
Ocular surface disease At the day of inform and consent, at admission date, post-op day1, post-op day7, post-op day14, post-op day30, post-op day60 OSDI score questionnaire ( the Outcomes Research Group at Allergan Inc ) in Thai version, slit lamp examination for signs of dry eye disease	—

Secondary

Measure	Time frame
Safety At the day of inform and consent, at admission date, post-op day1, post-op day7, post-op day14, post-op day30, post-op day60 Eye examination by slit lamp	—

Countries

Thailand

Contacts

Public ContactWeerawat Kiddee

Prince of Songkla University

kweerawat@hotmail.com6674455000

Outcome results

None listed

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