Safety, Efficacy Assessment of Geltim LP® 1 mg/g in Ocular Hypertensive or Glaucomatous Patients.

NCT01155219 | Completed Phase 4 Results

• 1 other identifier: LTG1030-PIV-12/07
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This phase IV study aims to assess the safety and the efficacy in intra ocular pressure of Geltim LP® 1 mg/g (0.1% unpreserved timolol maleate gel) in glaucomatous patients initially treated and stabilised by monotherapy of Xalatan® with ocular objective signs of intolerance to prostaglandin eye drops.

Conditions

Glaucoma

Keywords

Bilateral Glaucoma; Bilateral ocular hypertension; Bilateral primary open angle glaucoma; Bilateral ocular hypertension already treated and controlled by mono-therapy of Xalatan® (1drop per day); With local intolerance signs in at least one eye

Outcome Measures

Primary Outcomes (1)

• Ocular Tolerance

  Response defined as a combination of satisfactory or acceptable effect on IOP and a reduction of at least 20% of the total tolerance score in the worse eye.

  Day 84

Study Arms (2)

Geltim LP®

EXPERIMENTAL

Geltim LP® 1 mg/g (0.1 % timolol maleate, without preservative) packaged in single-dose containers (unidoses); one drop in the conjunctival sac of each eye in the morning (84 days).

Drug: Geltim LP 1 mg/g

Xalatan®

ACTIVE COMPARATOR

Xalatan® (Latanaprost) aqueous eye drop (one drop in the conjunctival sac of each eye in the evening during 84 days.

Drug: Xalatan

Interventions

Geltim LP 1 mg/g DRUG

one drop in the conjunctival sac of each eye in the morning (84 days).

Geltim LP®

Xalatan DRUG

one drop in the conjunctival sac of each eye in the morning (84 days).

Xalatan®

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent.
• Association of the 4 following criteria:
• \- Bilateral primary open angle glaucoma or bilateral ocular hypertension already treated and controlled by mono-therapy of Xalatan® (1drop per day),
• \- With local intolerance signs.

You may not qualify if:

• Presence of severe objective ocular sign.
• Any ocular hypertension other than primary ocular hypertension or primary chronic open angle glaucoma (such as congenital, angle closure glaucoma, secondary glaucoma).
• Absolute defect in the ten degrees central point of the visual field.
• Best far corrected visual acuity ≤ 1/10.

Sponsors & Collaborators

• Laboratoires Thea: lead

Study Sites (1)

Unknown Facility

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr Pascale Pouliquen
• Organization: Laboratoires Thea

p.pouliquen@laboratoires-thea.fr

0473981436

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2010
• First Posted: July 1, 2010
• Study Start: July 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: December 1, 2009
• Last Updated: April 4, 2017
• Results First Posted: October 29, 2014

Record last verified: 2010-07

Locations

FR (1)