Childhood GlaucomaPhase 2NCT01527682
Efficacy and Safety of Topically Applied Medical Therapy for the Treatment of Pediatric Glaucoma
A Phase 2 study testing Latanoprost, Dorzolamide in people with Childhood Glaucoma, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 12 years
- Conditions the study is for
- Childhood Glaucoma
- What is being tested?
- Latanoprost, Dorzolamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesItaly
- Study dates
- Jul 2009to Nov 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25123
A.O. Universitaria " Policlinico Vittorio Emanuele" P.O. Rodolico
Catania, 95123
About this study
Official title: Efficacy and Safety of Prostaglandin Analogue and Carbonic Anhydrase Inhibitor for the Treatment of Pediatric Glaucoma
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.
Read the 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.
- Conditions
- Childhood Glaucoma
- Being tested
- Latanoprost, Dorzolamide
- Keywords
- Intraocular pressure, Latanoprost, Dorzolamide
- Medical subject headings
- Hydrophthalmos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Latanoprost, DorzolamideDrug
Also called - Latanoprost, a prostaglandin analogue, - Dorzolamide, a potent inhibitor of carbonic anhydrase II
- 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
| Study group | Role | What they receive |
|---|---|---|
| Latanoprost, Dorzolamide | Other | According to intraocular (IOP) assessment, the eye will receive Latanoprost, Dorzolamide or both. Receives: Drug: Latanoprost, Dorzolamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (2)
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
Measured: 3 years
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2012 (estimated)
- Study startJul 2009
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Childhood GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luciano Quaranta MD, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Investigators
- Luciano Quaranta, MD, Principal investigator, Università di Brescia, Spedali Civili di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527682
- Sponsor's protocol ID
- 2008-004763-19
- Other IDs
- 2008
- Status last verified
- Sep 2019
- First submitted
- 16 Feb 2010
- Last updated
- 27 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Uva MG, Avitabile T, Reibaldi M, Bucolo C, Drago F, Quaranta L, Lionetti E, Longo A. Long-term efficacy of latanoprost in primary congenital glaucoma. Eye (Lond). 2014 Jan;28(1):53-7. doi: 10.1038/eye.2013.232. Epub 2013 Oct 25.
PubMed 24158022Quaranta L, Biagioli E, Galli F, Poli D, Rulli E, Riva I, Hollander L, Katsanos A, Longo A, Uva MG, Torri V, Weinreb RN. Latanoprost and Dorzolamide for the Treatment of Pediatric Glaucoma: The Glaucoma Italian Pediatric Study (Gipsy), Design and Baseline Characteristics. Adv Ther. 2016 Aug;33(8):1305-15. doi: 10.1007/s12325-016-0358-x. Epub 2016 Jun 16.
PubMed 27312975Quaranta L, Biagioli E, Riva I, Galli F, Poli D, Rulli E, Katsanos A, Longo A, Uva MG, Torri V, Weinreb RN. The Glaucoma Italian Pediatric Study (GIPSy): 1-Year Results. J Glaucoma. 2017 Nov;26(11):987-994. doi: 10.1097/IJG.0000000000000773.
PubMed 28957960
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Prostaglandin Analogue and Carbonic Anhydrase Inhibitor for the Treatment of Pediatric Glaucoma
- ClinicalTrials.gov ID
- NCT01527682
- Acronym / sponsor ID
- 2008-004763-19
- Conditions
- Childhood Glaucoma
- Keywords
- Intraocular pressure, Latanoprost, Dorzolamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Study start
- Jul 2009 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 7 Feb 2012 (estimated)
- Results
- Posted 27 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Latanoprost, Dorzolamide | Other | Drug: Latanoprost, DorzolamideAccording to intraocular (IOP) assessment, the eye will receive Latanoprost, Dorzolamide or both. |
Who may qualify
- Ages
- 1 month to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Latanoprost, DorzolamideAlso: - Latanoprost, a prostaglandin analogue, - Dorzolamide, a potent inhibitor of carbonic anhydrase II* 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 | Drug | Latanoprost, Dorzolamide |
Primary outcome
Percentage of Eyes With Response
Time frame: 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
2 secondary outcomes
Time to Treatment Failure (TTF)
Time frame: 3 years
Number of Eyes With an Adverse Event (AE)
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24158022Uva MG, Avitabile T, Reibaldi M, Bucolo C, Drago F, Quaranta L, Lionetti E, Longo A. Long-term efficacy of latanoprost in primary congenital glaucoma. Eye (Lond). 2014 Jan;28(1):53-7. doi: 10.1038/eye.2013.232. Epub 2013 Oct 25.
- Results publication: PubMed 27312975Quaranta L, Biagioli E, Galli F, Poli D, Rulli E, Riva I, Hollander L, Katsanos A, Longo A, Uva MG, Torri V, Weinreb RN. Latanoprost and Dorzolamide for the Treatment of Pediatric Glaucoma: The Glaucoma Italian Pediatric Study (Gipsy), Design and Baseline Characteristics. Adv Ther. 2016 Aug;33(8):1305-15. doi: 10.1007/s12325-016-0358-x. Epub 2016 Jun 16.
- Results publication: PubMed 28957960Quaranta L, Biagioli E, Riva I, Galli F, Poli D, Rulli E, Katsanos A, Longo A, Uva MG, Torri V, Weinreb RN. The Glaucoma Italian Pediatric Study (GIPSy): 1-Year Results. J Glaucoma. 2017 Nov;26(11):987-994. doi: 10.1097/IJG.0000000000000773.
- Individual participant dataSharing planned: No
Related trials for Childhood Glaucoma
Recruiting
Virtual Reality Visual Field Testing as an Alternative in Childhood Eye Disease
Visual Field Defect, Peripheral
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luciano Quaranta, MD principal investigator
Università di Brescia, Spedali Civili di Brescia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Latanoprost, Dorzolamide in people with Childhood Glaucoma, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Eyes With Response (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01527682, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019.