Trial Outcomes & Findings for Efficacy and Safety of Topically Applied Medical Therapy for the Treatment of Pediatric Glaucoma (NCT NCT01527682)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

37 participants

Primary outcome timeframe

3 years

Results posted on

2019-09-27

Participant Flow

Consecutive Primary Congenital Glaucoma not sufficiently responder to a single surgical procedure

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

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	37 69
Overall Study COMPLETED	29 45
Overall Study NOT COMPLETED	8 24

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Protocol Violation	8

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Latanoprost, Dorzolamide n=37 Participants 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
Age, Categorical <=18 years	37 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	4.1 years STANDARD_DEVIATION 3.8 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Region of Enrollment Italy	37 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Latanoprost, Dorzolamide n=43 eyes 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
Percentage of Eyes With Response	33 eyes

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Latanoprost, Dorzolamide n=45 eyes 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
Time to Treatment Failure (TTF)	NA eyes insufficient number of participants with events

SECONDARY outcome

Timeframe: 3 years

Population: Eyes affected by Primary congenital glaucoma not sufficiently responder to a single surgical procedure

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.

Outcome measures

Outcome measures
Measure	Latanoprost, Dorzolamide n=61 eyes 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
Number of Eyes With an Adverse Event (AE)	61 eyes

Adverse Events

Latanoprost / Dorzolamide

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Latanoprost / Dorzolamide n=37 participants at risk 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
Eye disorders Hypertrichosis	45.9% 17/37 • 3 years
Eye disorders Iris color modification	16.2% 6/37 • 3 years
Eye disorders Corneal epitheliopathy	45.9% 17/37 • 3 years
Eye disorders Allergic conjunctivitis	24.3% 9/37 • 3 years
Eye disorders Eyelid skin hyperpigmentation	2.7% 1/37 • 3 years

Additional Information

Prof. Luciano Quaranta

ASST Spedali Civili di Brescia

Phone: +39 030 3995

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place