Epiphora, Punctal Stenosis
Conditions
Keywords
Lacrimal Apparatus Diseases, Stenosis, Anti-Inflammatory Agents, Non-Steroidal
Brief summary
Establish the efficacy of combined treatment with nepafenac and lubricant versus lubricant alone in improving epiphora and resolving punctal stenosis in Mexican adults.
Detailed description
A two-month follow-up will be conducted. The study participants will be randomly assigned to two groups: the first group will receive treatment with nepafenac 0.1% ophthalmic suspension once daily and sodium carboxymethylcellulose 0.5% (lubricant) three times daily for eight weeks; the second group will receive treatment with placebo and lubricant only, administered three times daily for eight weeks. Initial evaluations will be conducted, followed by assessments at four and eight weeks to determine, through ophthalmological examination, the visibility of the lacrimal punctum using the Kashkouli scale, the assessment of epiphora according to the Munk scale, and the measurement of the external diameter and depth of the lacrimal punctum using OCT-SA.
Interventions
DRUGNepafenac and lubricant
A two-month follow-up will be conducted. The study participants will be randomly assigned to two groups: the first group will receive treatment with nepafenac 0.1% ophthalmic suspension once daily and sodium carboxymethylcellulose 0.5% (lubricant) three times daily for eight weeks; the second group will receive treatment with placebo and lubricant only, administered three times daily for eight weeks
DRUGPlacebo
A two-month follow-up will be conducted. The study participants will be randomly assigned to two groups: the first group will receive treatment with nepafenac 0.1% ophthalmic suspension once daily and sodium carboxymethylcellulose 0.5% (lubricant) three times daily for eight weeks; the second group will receive treatment with placebo and lubricant only, administered three times daily for eight weeks
Sponsors
Instituto de Oftalmología Fundación Conde de Valenciana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
This study is designed as a randomized clinical trial with a follow-up period of two months. Participants will be allocated into two groups through balanced block randomization. The first group will receive nepafenac ophthalmic suspension 0.1% once daily, in conjunction with sodium carboxymethylcellulose 0.5% three times daily, over an eight-week period. The second group will be administered a placebo alongside sodium carboxymethylcellulose 0.5% three times daily for the same duration. All assessments will be conducted by a single ophthalmologist. Prior to the initiation of treatment, at 4 and 8 weeks into the treatment, a clinical evaluation using a slit lamp will be performed to assess the visibility of the lacrimal punctum, utilizing the Kashkouli scale, and to evaluate epiphora according to the Munk scale. Additionally, baseline measurements of the external diameter and depth of the lacrimal punctum will be obtained using OCT-SA.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of epiphora secondary to lacrimal punctum stenosis of allergic or idiopathic origin. Age ≥ 18 years
Exclusion criteria
* Previous eye surgery, including eyelid or lacrimal duct surgery. Allergy to nepafenac. Previous application of botulinum toxin to the eyelids, medical treatment received at least 3 months prior to the study, treatment discontinuation, failure to attend scheduled follow-up appointments and severe adverse reactions to treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lacrimal punctal estenosis | From enrollment to the end, each month of treatment until 8 weeks | Lacrimal punctal stenosis measured by Optical Coherence Tomography and Kashkouli scale |
| Epiphora | From enrollment to the end, each month of treatment until 8 weeks | Epiphora measured by Munk scale |
Countries
Mexico
Outcome results
None listed