Efficacy and Safety of Topically Applied Medical Therapy for the Treatment of Pediatric Glaucoma

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2016-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Childhood Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Latanoprost, Dorzolamide

According to intraocular (IOP) assessment, the eye will receive Latanoprost, Dorzolamide or both.

Group Type OTHER

Latanoprost, Dorzolamide

Intervention Type DRUG

* 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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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- Latanoprost, a prostaglandin analogue - Dorzolamide, a potent inhibitor of carbonic anhydrase II

Eligibility Criteria

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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)

Minimum Eligible Age

1 Month

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No