Efficacy and Safety of T2762 and Vismed® in Dry Eye Syndrome

• Sponsor: Laboratoires Thea (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02023268
• Collaborator: (none)
• Enrollment: 105
• Location: 1
• Arms: 2
• Duration (Months): 14
• Patients Per Site Per Month: 7.5

Study Details

Study Description

Brief Summary

Comparison of the efficacy and safety of T2762 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndrome	Device: T2762; Device: Vismed®	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 105 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Phase III: Comparison of the Efficacy and Safety of T2762 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome
• Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: T2762	Device: T2762; 1 drop in each eye 3 to 6 times daily during 84 days
Active Comparator: Vismed®	Device: Vismed®; 1 drop in each eye 3 to 6 times daily during 84 days

Outcome Measures

Primary Outcome Measures

1. Global Ocular Staining (With Oxford Scale - Ranges : 0-15) [Baseline and Day 35]

   Change from Baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome) Global Ocular Staining With the Oxford Scale measured surface damage to treated eyes(by T2762 or vismed).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Signed and dated informed consent

• Male or female aged from ≥ 18 years old.

• Known Dry Eye Syndrome requiring artificial tears within the last 3 months prior to study selection.

Exclusion Criteria:

• Best far corrected visual acuity < 1/10

• Severe blepharitis

• Severe Dry Eye

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Clermont-Ferrand		France

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: NCT02023268
• Other Study ID Numbers: LT2762-PIII-08/13; 2013-A01292-43
• First Posted: Dec 30, 2013
• Last Update Posted: Aug 24, 2017
• Last Verified: Nov 1, 2015

• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome

Study Results

Participant Flow

Arm/Group Title	T2762	Vismed®
Arm/Group Description	T2762: 1 drop in each eye 3 to 6 times daily during 84 days	Vismed®: 1 drop in each eye 3 to 6 times daily during 84 days
Period Title: Overall Study
STARTED	52	53
COMPLETED	52	49
NOT COMPLETED	0	4

Baseline Characteristics

Arm/Group Title	T2762	Vismed®	Total
Arm/Group Description	T2762: 1 drop in each eye 3 to 6 times daily during 84 days	Vismed®: 1 drop in each eye 3 to 6 times daily during 84 days	Total of all reporting groups
Overall Participants	52	53	105
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	34 65.4%	35 66%	69 65.7%
>=65 years	18 34.6%	18 34%	36 34.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60 (12.2)	58.5 (13.4)	59.2 (12.8)
Sex: Female, Male (Count of Participants)
Female	41 78.8%	45 84.9%	86 81.9%
Male	11 21.2%	8 15.1%	19 18.1%
Region of Enrollment (participants) [Number]
France	31 59.6%	31 58.5%	62 59%
Tunisia	21 40.4%	22 41.5%	43 41%

Outcome Measures

1. Primary Outcome

Title	Global Ocular Staining (With Oxford Scale - Ranges : 0-15)
Description	Change from Baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome) Global Ocular Staining With the Oxford Scale measured surface damage to treated eyes(by T2762 or vismed).
Time Frame	Baseline and Day 35

Outcome Measure Data

Analysis Population Description

14 patients with major protocol deviations were excluded of the analysed population.

Arm/Group Title	T2762	Vismed
Arm/Group Description	T2762: drop in each eye 3 to 6 times daily during 84 days	Vismed : 1 drop in each eye 3 to 6 times daily during 84 days
Measure Participants	46	45
Mean (Standard Deviation) [score on a scale]	-2.5 (2.0)	-2.7 (1.7)

Adverse Events

Arm/Group Title	T2762		Vismed®
Arm/Group Description	T2762: 1 drop in each eye 3 to 6 times daily during 84 days		Vismed®: 1 drop in each eye 3 to 6 times daily during 84 days
All Cause Mortality
	T2762		Vismed®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	T2762		Vismed®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52 (0%)		0/53 (0%)
Other (Not Including Serious) Adverse Events
	T2762		Vismed®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52 (0%)		0/53 (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 from without prior written agreement of THEA