Childhood Glaucoma
Conditions
Keywords
Intraocular pressure, Latanoprost, Dorzolamide
Brief summary
Objectives: The study will assess the ocular hypotensive effect of latanoprost and dorzolamide in a selected sample of patients affected by primary Pediatric Glaucoma (PG), refractory to surgical procedures. Safety will be assessed, too.In the first version of the protocol 96 eyes were forecasted to complete the enrolment. The protocol was then amended and now to complete the study 68 eyes should be included. This number of eyes could be achieved by recruiting from 34 to 68 patients due to not in all patients both eyes should be eligible for the study.
Detailed description
Study design: Single arm, prospective, experimental study. Due to ethical reasons and in order to adhere as much as possible to current clinical practice, the presence of a control arm is not planned. Due to the non-comparative nature of the study, no blinding of treatment is planned.
Interventions
DRUGLatanoprost, Dorzolamide
* Latanoprost 0.005% ophthalmic solution given once a day at nighttime (9.00 PM) * Dorzolamide 2% ophthalmic solution given three times a day as a monotherapy, two times a day if in combination with latanoprost
Sponsors
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 12 Years
Healthy volunteers
No
Inclusion criteria
* Children of either sexes, aged 0-12 years * Diagnosis of mono- or bilateral primary congenital glaucoma * IOP greater than or equal to 22 mmHg and lower than 27 mmHg * Only one previous ocular hypotensive surgical procedure for treatment of glaucoma among the following: goniotomy, trabeculotomy, trabeculotomy with adjunct of mitomycin C) (only for medical treatment at least one month before) * Parent informed consent to data processing (at registration) * Parent informed consent before any study procedure
Exclusion criteria
* Secondary glaucoma (Sturge-Weber syndrome, type I neurofibromatosis, retinoblastoma, steroid-induced glaucoma, etc.) * Presence of concomitant abnormalities of the anterior segment of the eye (cataract, iridocorneal dysgenesia, congenital uveal ectropion uvea, etc.) * Previous treatment with the study drugs * Presence of concomitant systemic diseases (asthma, hypertension, cardiac disease, renal failure, etc.) that needs treatment with drugs, that could influence IOP (steroids, beta-blockers, angiotensin-converting-enzyme inhibitor -inhibitors diuretics, etc.) * Abnormalities of the cornea that could influence IOP readings (marked cornea edema)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Eyes With Response | 3 years | defined as those eyes in which the decrease of intraocular pressure (IOP) of at least 20% with respect to baseline assessment will be achieved and maintained during the 3-year period of study duration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Treatment Failure (TTF) | 3 years | calculated as the time from the date of baseline visit to the date in which the medical treatment will be stopped, since IOP control will be considered not satisfactory |
| Number of Eyes With an Adverse Event (AE) | 3 years | The occurrence of the following events will be monitored: growth of the eyelashes (hypertrichosis), changes iris colour, corneal epitheliopathy, allergic conjunctivitis, increase of central corneal thickness, non-serious and serious adverse event occurrence. |
Countries
Italy
Participant flow
Recruitment details
Consecutive Primary Congenital Glaucoma not sufficiently responder to a single surgical procedure
Pre-assignment details
Patients affected with Primary congenital glaucoma will be recruited if after a single surgical procedure Intraocular pressure will be ranging from 22 and 27 mm Hg
Participants by arm
| Arm | Count |
|---|---|
| Latanoprost, Dorzolamide According to IOP assessment, the eye will receive Latanoprost, Dorzolamide or both.
Latanoprost, Dorzolamide: - Latanoprost 0.005% ophthalmic solution given once a day at nighttime (9.00 PM)
\- Dorzolamide 2% ophthalmic solution given three times a day as a monotherapy, two times a day if in combination with latanoprost | 37 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 8 |
Baseline characteristics
| Characteristic | Latanoprost, Dorzolamide |
|---|---|
| Age, Categorical <=18 years | 37 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 4.1 years STANDARD_DEVIATION 3.8 |
| Region of Enrollment Italy | 37 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 37 |
| other Total, other adverse events | 22 / 37 |
| serious Total, serious adverse events | 0 / 37 |
Outcome results
Primary
Percentage of Eyes With Response
defined as those eyes in which the decrease of intraocular pressure (IOP) of at least 20% with respect to baseline assessment will be achieved and maintained during the 3-year period of study duration
Time frame: 3 years
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Latanoprost, Dorzolamide | Percentage of Eyes With Response | 33 eyes |
95% CI: [64.1, 89.4]
Secondary
Number of Eyes With an Adverse Event (AE)
The occurrence of the following events will be monitored: growth of the eyelashes (hypertrichosis), changes iris colour, corneal epitheliopathy, allergic conjunctivitis, increase of central corneal thickness, non-serious and serious adverse event occurrence.
Time frame: 3 years
Population: Eyes affected by Primary congenital glaucoma not sufficiently responder to a single surgical procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Latanoprost, Dorzolamide | Number of Eyes With an Adverse Event (AE) | 61 eyes |
Secondary
Time to Treatment Failure (TTF)
calculated as the time from the date of baseline visit to the date in which the medical treatment will be stopped, since IOP control will be considered not satisfactory
Time frame: 3 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Latanoprost, Dorzolamide | Time to Treatment Failure (TTF) | NA eyes |