Efficacy and Safety of Topically Applied Medical Therapy for the Treatment of Pediatric Glaucoma
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2015 by Luciano Quaranta MD, Azienda Ospedaliera Spedali Civili di Brescia.
Recruitment status was: Active, not recruiting
Information provided by (Responsible Party):
Luciano Quaranta MD, Azienda Ospedaliera Spedali Civili di Brescia
First received: February 16, 2010
Last updated: August 31, 2015
Last verified: August 2015
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.
Drug: Latanoprost, Dorzolamide
||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
||Efficacy and Safety of Prostaglandin Analogue and Carbonic Anhydrase Inhibitor for the Treatment of Pediatric Glaucoma
Primary Outcome Measures:
Secondary Outcome Measures:
- Time to treatment failure (TTF) [ Time Frame: 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
- Incidence of adverse events (AEs) [ Time Frame: 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.
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2017 (Final data collection date for primary outcome measure)
According to IOP assessment, the eye will receive Latanoprost, Dorzolamide or both.
Drug: 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
- - Latanoprost, a prostaglandin analogue
- - Dorzolamide, a potent inhibitor of carbonic anhydrase II
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.
|Ages Eligible for Study:
||up to 12 Years (Child)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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, ACE-inhibitors diuretics, etc.)
- Abnormalities of the cornea that could influence IOP readings (marked cornea edema)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01527682
|Azienda Ospedaliera Spedali Civili di Brescia
|Brescia, Italy, 25123 |
|A.O. Universitaria " Policlinico Vittorio Emanuele" P.O. Rodolico
|Catania, Italy, 95123 |
Azienda Ospedaliera Spedali Civili di Brescia
||Luciano Quaranta, MD
||Università di Brescia, Spedali Civili di Brescia
||Luciano Quaranta MD, Associate Professor in Ophthalmology, Azienda Ospedaliera Spedali Civili di Brescia
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 16, 2010
||August 31, 2015
Keywords provided by Luciano Quaranta MD, Azienda Ospedaliera Spedali Civili di Brescia:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 17, 2017
Infant, Newborn, Diseases
Carbonic Anhydrase Inhibitors
Molecular Mechanisms of Pharmacological Action