Efficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis

• Sponsor: Laboratoires Thea (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01156025
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 2
• Duration (Months): 15
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

The study objective is to evaluate the efficacy and the safety of GV 550 in comparison to placebo in patients with acute adenoviral keratoconjuncivitis.

Condition or Disease	Intervention/Treatment	Phase
Acute Adenoviral Keratoconjunctivitis	Drug: GV550; Drug: placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis (Phase II Pilot Study, Multicentre, International, Randomised, Double-masked, Placebo-controlled, 2x40 Patients)
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Feb 1, 2010
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GV550 (Ganciclovir 1.5 mg/g ophtalmic gel)	Drug: GV550; Ganciclovir 1.5 mg/g, 1 drop 10 times daily at D0 and D1 and 1 drop 5 times daily from D2 to D9 + additionnal treatment (Hyabak® eye drops: 5 times daily from D10 to D30)
Placebo Comparator: Placebo Placebo ophtalmic gel	Drug: placebo; 1 drop 10 times daily at D0 and D1 and 1 drop 5 times daily from D2 to D9 + additionnal treatment (Hyabak® eye drops: 5 times daily from D10 to D30)

Outcome Measures

Primary Outcome Measures

1. efficacy of GV550 [D0 to D4]

   The evolution of the inflammation The virus load by quantitative PCR

Secondary Outcome Measures

1. efficacy of GV550 []

   The assessment of the patient's symptomatology evaluation The score of each subjective signs The score of each objective signs The occurrence of focal corneal sub epithelial infiltrates (nummular stromal infiltration) The occurrence of pseudo membranes The virus load between D0-D10

2. Ocular safety []

   To compare the ocular tolerance of GV550 eye drops versus placebo eye drops with respect of the assessment of the global local tolerance assessment by the investigator and by the patient To compare the ocular safety of GV550 eye drops versus placebo eye drops with respect of the assessment of the best corrected far visual acuity and ocular Adverse Event (AE) reporting at each visit

3. Systemic safety []

   - To compare the systemic safety of GV550 eye drops versus placebo eye drops with respect of the systemic AE reporting at each visit

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Written informed consent

• Male or female aged from 18 to 80 years old

• Acute adenoviral keratoconjunctivitis

Exclusion Criteria:

• Active ocular allergy

• Ocular herpès disease

• History of bacterial conjunctivitis / blepharoconjunctivitis within the last month before the inclusion visit

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Laboratoires Thea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01156025
• Other Study ID Numbers: LTGV550-PII-11/06; 2007-002455-16
• First Posted: Jul 2, 2010
• Last Update Posted: Jul 2, 2010
• Last Verified: Jul 1, 2010

• Keywords provided by , ,: GV550; Acute adenoviral keratoconjunctivitis
• Additional relevant MeSH terms: Keratoconjunctivitis

Study Results

No Results Posted as of Jul 2, 2010