LT2762-PIV-11/13
Research type
Research Study
Full title
Comparison of the efficacy and safety of Thealoz-Duo® (T2762) versus Optive® in the treatment of moderate to severe Dry Eye Syndrome
IRAS ID
167100
Contact name
Marielle Estrade
Contact email
Sponsor organisation
Laboratoires Théa
Duration of Study in the UK
0 years, 11 months, 0 days
Research summary
Dry Eye disease is defined by insufficient tear production or excessive tear evaporation and lead to ocular surface disorders.
Main ocular symptoms for dry eye syndrome are blurred vision, burning sensations, sand in the eye, tearing, stinging and eye redness.
All these symptoms cause a strong alteration of quality of life.
Artificial tears are used in first line therapy for dry eye disease.
Clinical studies have demonstrated the efficacy of hyaluronic acid or trehalose to reduce eye discomfort caused by dry eye, by increasing the volume of tears and decreasing evaporation.
Laboratoires Théa have developed a new ophthalmic solution (T2762) combining these 2 molecules. This treatment is currently marketed in Italy and Germany (brand name is Thealoz-Duo®).The main purpose of this study to compare the efficacy and safety of Thealoz-Duo® (T2762) versus Optive® (another eye drop which is currently marketed and is considered as a reference) in the treatment of moderate to severe Dry Eye Syndrome and to further evaluate the potential clinical benefit of T2762 eye drop.
Patients taking part in this study will use only artificial tears (Hydrabak®) as ocular treatment for 7 to 14 days. Then they will be treated either with T2762 or the reference product (Optive®) for 84 days (+/- 7 days).
Four visits are planned during the study (ophthalmic examinations requested for this study are routine examinations) :
- Visit 1 (selection visit) will be performed 7 to 14 days before starting treatment with Thealoz-Duo® (T2762) or Optive®.
- Visit 2 (inclusion visit) : start of treatment with Thealoz-Duo® (T2762) or Optive®.
- Visit 3 (28 days +/- 3 days after visit 2) : follow-up visit
- Visit 4 (84 days +/- 7 days after visit 2) : final visit.REC name
London - Fulham Research Ethics Committee
REC reference
15/LO/0472
Date of REC Opinion
7 May 2015
REC opinion
Further Information Favourable Opinion