Comparison of Bimatoprost and Latanoprost in Patients With Chronic Angle-Closure Glaucoma: A Randomized Cross-Over Study

NCT00567788 | Unknown DMC

• 2 other identifiers: R353/11/2004SQGL08
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized observer-masked cross-over study to compare the intraocular pressure (IOP) reducing effect of latanoprost with bimatoprost in subjects with chronic angle closure glaucoma (CACG) with raised IOP. Study subjects will be randomized to receive either latanoprost once daily or bimatoprost once daily for 6 weeks, after which they will be crossed over to the other medication for another 6 weeks. The IOP-reducing effect of the medications will be assessed by the reduction in IOP after each medication compared to baseline. The study will be carried out in at least 2 Singapore hospitals.

Conditions

Glaucoma, Angle-Closure

Keywords

Glaucoma, angle-closure

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is defined as IOP reduction from baseline measurement (week 0) to the measurement at week 6 at each treatment period.

  6 weeks

Secondary Outcomes (1)

• Incidence of side effects of each medication.

  6 weeks after each treatment period

Study Arms (2)

1

ACTIVE COMPARATOR

Study subjects will be randomized to receive either latanoprost once daily or bimatoprost once daily for 6 weeks, after which they will be crossed over to the other medication for another 6 weeks. The IOP-reducing effect of the medications will be assessed by the reduction in IOP after each medication compared to baseline.

Drug: Latanoprost-Bimatoprost

2

ACTIVE COMPARATOR

Study subjects will be randomized to receive either latanoprost once daily or bimatoprost once daily for 6 weeks, after which they will be crossed over to the other medication for another 6 weeks. The IOP-reducing effect of the medications will be assessed by the reduction in IOP after each medication compared to baseline.

Drug: Bimatoporost-Latanoprost

Interventions

Latanoprost-Bimatoprost DRUG

latanoprost 0.005% once daily followed by bimatoprost 0.03%

Also known as: Xalatan, Lumigan

1

Bimatoporost-Latanoprost DRUG

bimatoprost 0.03% once daily followed by latanoprost 0.005%

Also known as: Xalatan, Lumigan

2

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral or bilateral CACG
• Age more than or equal to 40 years old
• Informed consent obtained at pre-study visit for all patients

You may not qualify if:

• Secondary glaucoma such as uveitic or neovascular glaucoma
• One eye eligible and fellow eye on unsuitable glaucoma treatment for this trial
• IOP \> 36 mmHg at Pre-study visit
• Advanced glaucoma at risk of progression. This is defined as vertical cup-disc ratio \> 0.9 and/or central visual field loss with a sensitivity of \< 10 dB in any of the 4 visual field test points closest to fixation
• Ocular infection or inflammation (except when related to peripheral iridotomy) within 3 months of the prestudy visit
• On more than two anti-glaucoma medications
• Previous intraocular surgery apart from laser peripheral iridotomy
• Previous trauma to the eye, with angle damage
• Ocular treatment with a steroid or non-steroidal anti-inflammatory medication within 1 month of the prestudy visit.
• Use of contact lens.
• Cornea infection or other cornea abnormalities.
• Ocular diseases such as dry eye or retinal pathology.
• Oral medications, such as diuretics, known to affect IOP.
• Cerebrovascular, hepatic, renal, metabolic disease.
• Known allergy to benzalkonium, or any other components of latanoprost/bimatoprost.

Sponsors & Collaborators

• Singapore National Eye Centre: lead
• Allergan: collaborator

Study Sites (1)

Singapore National Eye Centre

Singapore, 168751, Singapore

Location

MeSH Terms

Conditions

Glaucoma, Angle-Closure

Interventions

Latanoprost; Bimatoprost

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Amides; Organic Chemicals; Cloprostenol

Study Officials

• Tin Aung

  SNEC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: December 4, 2007
• First Posted: December 5, 2007
• Study Start: July 1, 2006
• Study Completion: July 1, 2008
• Last Updated: December 5, 2007

Record last verified: 2007-11

Locations

SG (1)