Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Latanoprost, Dorzolamide | Other | According to intraocular (IOP) assessment, the eye will receive Latanoprost, Dorzolamide or both. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Latanoprost, Dorzolamide | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 years |
| Number of Eyes With an Adverse Event (AE) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Luciano Quaranta, MD | Università di Brescia, Spedali Civili di Brescia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Spedali Civili di Brescia | Brescia | 25123 | Italy | |||
| A.O. Universitaria " Policlinico Vittorio Emanuele" P.O. Rodolico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24158022 | Background | 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. | |
| 27312975 | Result | Quaranta 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Consecutive Primary Congenital Glaucoma not sufficiently responder to a single surgical procedure
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Units | eyes | 3 years | eyes | eyes |
|
|
3 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertrichosis | Eye disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Luciano Quaranta | ASST Spedali Civili di Brescia | +39 030 3995 | 847 | luciano.quaranta@unibs.it |
Not provided
| ID | Term |
|---|---|
| D006871 | Hydrophthalmos |
| ID | Term |
|---|---|
| D005124 | Eye Abnormalities |
| D005128 | Eye Diseases |
| D005902 | Glaucoma, Open-Angle |
| D005901 | Glaucoma |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077338 | Latanoprost |
| C062765 | dorzolamide |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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. |
| 3 years |
| Catania |
| 95123 |
| Italy |
| 28957960 | Result | Quaranta 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. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Participants |
|
| 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 | Posted | Median | Inter-Quartile Range | eyes | 3 years | eyes | eyes |
|
|
|
| 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. | Eyes affected by Primary congenital glaucoma not sufficiently responder to a single surgical procedure | Posted | Number | eyes | 3 years | eyes | eyes |
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| 22 |
| 37 |
| Iris color modification | Eye disorders | Systematic Assessment |
|
| Corneal epitheliopathy | Eye disorders | Systematic Assessment |
|
| Allergic conjunctivitis | Eye disorders | Systematic Assessment |
|
| Eyelid skin hyperpigmentation | Eye disorders | Systematic Assessment |
|
Not provided
Not provided
| D009798 |
| Ocular Hypertension |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |