Comparison of the Efficacy and Safety of T2762 Versus Optive® in the Treatment of Moderate to Severe Dry Eye Syndrome

• Sponsor: Laboratoires Thea (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02617095
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Arms: 2
• Duration (Months): 20
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the efficacy and safety of T2762 versus Optive® in the treatment of moderate to severe Dry Eye Syndrome.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndrome	Device: T2762; Device: Optive	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Comparison of the Efficacy and Safety of T2762 Versus Optive® in the Treatment of Moderate to Severe Dry Eye Syndrome
• Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: T2762 One drop of T2762 in each eye 3 to 6 times daily	Device: T2762; One drop in each eye 3 to 6 times daily
Active Comparator: Optive One drop of Optive in each eye 3 to 6 times daily	Device: Optive; One drop in each eye 3 to 6 times daily

Outcome Measures

Primary Outcome Measures

1. Change of the symptomatology evaluation on a Visual Analogic Scale [Day 28]

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 ≥ 18 years old.

• Diagnosis of moderate to severe dry eye syndrome

Exclusion Criteria:

• Pregnancy, lactation.

• Childbearing potential woman who is not using a reliable method of contraception and is not surgically sterilised.

• Inability of patient to understand the study procedures and thus inability to give informed consent.

• Non-compliant patient

• Participation in another clinical study at the same time as the present study.

• Participation to the present study during the exclusion period of another clinical study.

• Already included once in this study.

• Ward of court.

• Patient not covered by government health care scheme

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Laboratoires Thea

Investigators

• Principal Investigator: Frank Larkin, Professor, Moorfields Eye Hospital -162 city road - London
• Principal Investigator: Friedrich KRUSE, Professor, Augenklinik mit Poliklinik - Swabachanlage 6 - 91054 Erlangen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Laboratoires Thea
• ClinicalTrials.gov Identifier: NCT02617095
• Other Study ID Numbers: LT2762-PIV-11/13
• First Posted: Nov 30, 2015
• Last Update Posted: Mar 8, 2017
• Last Verified: Mar 1, 2017

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

Study Results

No Results Posted as of Mar 8, 2017