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Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT03331770
Date of registration:	25/10/2017
Prospective Registration:	No
Primary sponsor:	Laboratorios Poen
Public title:	Efficacy and Tolerability of an Innovative Formulation of BAK-free Latanoprost
Scientific title:	Multicentric Study to Evaluate the Efficacy and Tolerability of an Innovative Formulation of Benzalkonium Chloride-free Latanoprost in Patients With Primary Open-Angle Glaucoma
Date of first enrolment:	January 6, 2017
Target sample size:	103
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03331770
Study type:	Interventional
Study design:	Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	Phase 4

Countries of recruitment
Argentina

Contacts

Name:	Alejo Peyret, PhD
Address:
Telephone:
Email:
Affiliation:	Hospital Durand

Name:	Daniel Grigera, PhD
Address:
Telephone:
Email:
Affiliation:	Hospital Santa Lucia

Name:	Javier Casiraghi, PhD
Address:
Telephone:
Email:
Affiliation:	Hospital de Clínicas "Jose de San Martin"

Key inclusion & exclusion criteria

Inclusion Criteria:

- Men and women aged = 18 years

- Diagnosed with primary open-angle glaucoma or pseudoexfoliative glaucoma.

- Receiving containing-BAK latanoprost as monotherapy for at least 6 months

- Pachymetry between 520 and 580 microns

- Informed consent given

Exclusion Criteria:

- History of allergic hypersensitivity or poor tolerance to latanoprost or any
components of the formula

- Angle closure glaucoma or secondary glaucoma

- History of recent previous glaucoma surgery or trabeculoplasty (less than 1 year of
surgery)

- History of cataract surgery during the last 6 months

- History of uveitis or intraocular inflammation

- Corneal alteration

- Pregnant patients, who wish to conceive or who are in the nursing period.

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Primary Open-angle Glaucoma

Intervention(s)

Drug: Latanoprost Ophthalmic Product

Primary Outcome(s)

Intraocular pressure [Time Frame: At the baseline (still on treatment with BAK-containing latanoprost)]

Intraocular pressure [Time Frame: After 12 weeks of treatment with BAK-free latanoprost]

Intraocular pressure [Time Frame: After 8 weeks of treatment with BAK-free latanoprost]

Intraocular pressure [Time Frame: After 4 weeks of treatment with BAK-free latanoprost]

Secondary Outcome(s)

Conjunctival hyperemia [Time Frame: At the baseline (still on treatment with BAK-containing latanoprost)]

Corneal epithelial fluorescein staining [Time Frame: After 12 weeks of treatment with BAK-free latanoprost]

Ocular Surface Disease Index (OSDI) [Time Frame: After 12 weeks of treatment with BAK-free latanoprost]

Tear meniscus height [Time Frame: After 12 weeks of treatment with BAK-free latanoprost]

Break up time (BUT) [Time Frame: After 12 weeks of treatment with BAK-free latanoprost]

Ocular Surface Disease Index (OSDI) [Time Frame: After 4 weeks of treatment with BAK-free latanoprost]

Schirmer I test [Time Frame: After 8 weeks of treatment with BAK-free latanoprost]

Tear meniscus height [Time Frame: At the baseline (still on treatment with BAK-containing latanoprost)]

Conjunctival hyperemia [Time Frame: After 8 weeks of treatment with BAK-free latanoprost]

Schirmer I test [Time Frame: After 12 weeks of treatment with BAK-free latanoprost]

Break up time (BUT) [Time Frame: After 8 weeks of treatment with BAK-free latanoprost]

Conjunctival hyperemia [Time Frame: After 12 weeks of treatment with BAK-free latanoprost]

Corneal epithelial fluorescein staining [Time Frame: After 4 weeks of treatment with BAK-free latanoprost]

Corneal epithelial fluorescein staining [Time Frame: After 8 weeks of treatment with BAK-free latanoprost]

Corneal epithelial fluorescein staining [Time Frame: At the baseline (still on treatment with BAK-containing latanoprost)]

Ocular Surface Disease Index (OSDI) [Time Frame: After 8 weeks of treatment with BAK-free latanoprost]

Ocular Surface Disease Index (OSDI) [Time Frame: At the baseline (still on treatment with BAK-containing latanoprost)]

Tear meniscus height [Time Frame: After 8 weeks of treatment with BAK-free latanoprost]

Tear meniscus height [Time Frame: After 4 weeks of treatment with BAK-free latanoprost]

Break up time (BUT) [Time Frame: After 4 weeks of treatment with BAK-free latanoprost]

Break up time (BUT) [Time Frame: At the baseline (still on treatment with BAK-containing latanoprost)]

Schirmer I test [Time Frame: After 4 weeks of treatment with BAK-free latanoprost]

Schirmer I test [Time Frame: At the baseline (still on treatment with BAK-containing latanoprost)]

Conjunctival hyperemia [Time Frame: After 4 weeks of treatment with BAK-free latanoprost]

Secondary ID(s)

SOLEMU03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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