T1030: Safety, Efficacy Assessment of Geltim LP® 1 mg/g in Ocular Hypertensive or Glaucomatous Patients.

• Sponsor: Laboratoires Thea (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01155219
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 2
• Duration (Months): 17
• Patients Per Site Per Month: 8.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Drug: Geltim LP 1 mg/g; Drug: Xalatan	Phase 4

Detailed Description

The primary objectives are to compare the safety and the efficacy of Geltim LP® 1mg/g eye drops versus Xalatan® eye drops with respect to:

The assessment of the ocular tolerance:

• Ocular symptoms

• Objective ocular signs.

The maintain of the IOP efficient lowering effect. Comparison between the 2 study products of the mean basal IOP after a 12 weeks treatment period (84 days ±7).

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy Assessment of Geltim LP® 1 mg/g (Unpreserved Timolol Gel - TG1030) in Ocular Hypertensive or Glaucomatous Patients Stabilized by Xalatan® With Ocular Intolerance Signs.
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Jul 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Geltim LP® 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; one drop in the conjunctival sac of each eye in the morning (84 days).
Active Comparator: Xalatan® Xalatan® (Latanaprost) aqueous eye drop (one drop in the conjunctival sac of each eye in the evening during 84 days.	Drug: Xalatan; one drop in the conjunctival sac of each eye in the morning (84 days).

Outcome Measures

Primary Outcome Measures

1. Ocular Tolerance [Day 84]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Written informed consent.

• Association of the 4 following criteria:

1. • Bilateral primary open angle glaucoma or bilateral ocular hypertension already treated and controlled by mono-therapy of Xalatan® (1drop per day),
2. • With local intolerance signs.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Clermont-Ferrand		France	63000

Sponsors and Collaborators

• Laboratoires Thea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Laboratoires Thea
• ClinicalTrials.gov Identifier: NCT01155219
• Other Study ID Numbers: LTG1030-PIV-12/07
• First Posted: Jul 1, 2010
• Last Update Posted: Apr 4, 2017
• Last Verified: Jul 1, 2010

• Keywords provided by Laboratoires Thea: 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
• Additional relevant MeSH terms: Glaucoma; Latanoprost

Study Results

Participant Flow

Arm/Group Title	Geltim LP®	Xalatan®
Arm/Group Description	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). Geltim LP 1 mg/g: one drop in the conjunctival sac of each eye in the morning (84 days).	Xalatan® (Latanaprost) aqueous eye drop (one drop in the conjunctival sac of each eye in the evening during 84 days. Xalatan: one drop in the conjunctival sac of each eye in the morning (84 days).
Period Title: Overall Study
STARTED	77	73
COMPLETED	73	70
NOT COMPLETED	4	3

Baseline Characteristics

Arm/Group Title	Geltim LP®	Xalatan®	Total
Arm/Group Description	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). Geltim LP 1 mg/g: one drop in the conjunctival sac of each eye in the morning (84 days).	Xalatan® (Latanaprost) aqueous eye drop (one drop in the conjunctival sac of each eye in the evening during 84 days. Xalatan: one drop in the conjunctival sac of each eye in the morning (84 days).	Total of all reporting groups
Overall Participants	77	73	150
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.94 (11.79)	64.86 (11.62)	65.41 (11.68)
Sex: Female, Male (Count of Participants)
Female	49 63.6%	50 68.5%	99 66%
Male	28 36.4%	23 31.5%	51 34%
Region of Enrollment (participants) [Number]
France	77 100%	73 100%	150 100%

Outcome Measures

1. Primary Outcome

Title	Ocular Tolerance
Description	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.
Time Frame	Day 84

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	Geltim LP®	Xalatan®
Arm/Group Description	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). Geltim LP 1 mg/g: one drop in the conjunctival sac of each eye in the morning (84 days).	Xalatan® (Latanaprost) aqueous eye drop (one drop in the conjunctival sac of each eye in the evening during 84 days. Xalatan: one drop in the conjunctival sac of each eye in the morning (84 days).
Measure Participants	71	70
Number [participants]	65 84.4%	34 46.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Geltim LP®, Xalatan®
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments
	Method	Fisher Exact
	Comments

Adverse Events

Arm/Group Title	Geltim LP®		Xalatan®
Arm/Group Description	Geltim LP® 1 mg/g (0.1 % unpreserved timolol maleate gel) One drop in the conjunctival sac of each eye in the morning		Latanoprost One drop in the conjunctival sac of each eye in the evening
All Cause Mortality
	Geltim LP®		Xalatan®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Geltim LP®		Xalatan®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/77 (0%)		0/73 (0%)
Other (Not Including Serious) Adverse Events
	Geltim LP®		Xalatan®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/77 (0%)		0/73 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

All the results of the Trial are the sole and exclusive property of THEA, and cannot be used in whatever form without prior written agreement of THEA.