Aplicattion of Hipromelosis (Ophthalmic Gel) in Lacrimal Punctum Closure in Dry Eye Patients

Occlusion of Inferior Lacrimal Punctun with Hypromelosis in Dry Eye Patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-6pvzyt

Enrollment

Unknown

Registered

2013-07-31

Start date

2011-09-01

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Dry eye, Punctal occlusion

Interventions

Patients with dry eye accompanied the ophthalmology department of the Hospital Universitário de Brasília of the Universidade de Brasilia who were dissatisfied with their clinical condition were invit

Topical anesthesia with one drop in each eye with proximetacaine 0.5%. Application of 0.05 ml of 2% hypromellose (hydroxypropyl methylcellulose) in the lower lacrimal punctum of the eye choosen. A sim

Procedure/surgery

E04.030

Eligibility

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Age over 18 years; Age under 70 years; Ambulatorial patients of HUB-Hospital Universitário de Brasília ; Dry eye patients; Patients complaining about current treatment; no other ocular diseases previously or during the study.

Exclusion criteria

Exclusion criteria: Develop systemic or ocular disease during the study; Initiate use of new systemic or ophthalmologic medications in the last 6 months.

Design outcomes

Primary

Measure	Time frame
To calculate the sample we usede variation of at least 60% in each variable with a 80% power test and a 5% significancy level. To satisfy all the variables we get a number of at least 23 eyes in each group. We hope to obtain results 4 weeks after the procedure. Reduction of the foreing body sensation evalueted by visual analogue scale(0-10). Reduction of the burning sensation evalueted by visual analogue(0-10). Reduction of the redness evalueted by visual analogue(0-10). Fluorescein score reduction(0-9). Rosa Bengala score reduction(0-9). Schirmer with anesthetic score improvemment, evaluation of tears in mm. The occlusion of inferior lacrimal punctum with hypromelosis was effective in dry eye treatment in all evalueted variables.	—

Measure

Time frame

To calculate the sample we usede variation of at least 60% in each variable with a 80% power test and a 5% significancy level. To satisfy all the variables we get a number of at least 23 eyes in each group. We hope to obtain results 4 weeks after the procedure. Reduction of the foreing body sensation evalueted by visual analogue scale(0-10). Reduction of the burning sensation evalueted by visual analogue(0-10). Reduction of the redness evalueted by visual analogue(0-10). Fluorescein score reduction(0-9). Rosa Bengala score reduction(0-9). Schirmer with anesthetic score improvemment, evaluation of tears in mm. The occlusion of inferior lacrimal punctum with hypromelosis was effective in dry eye treatment in all evalueted variables.

—

Secondary

Measure	Time frame
Discover the duration of the effects of the procedure. Evalution of side effects. The patients improved betwenn 28 and 56 days after the intervention. No side effects were registered.	—

Countries

Brazil

Contacts

Public ContactLeonardo Oliveira

Hospital Universitário de Brasília - Universidade de Brasília

leonardocapita@gmail.com55-(61)-95577571

Outcome results

None listed

Source: REBEC (via WHO ICTRP)