Optive Brand for Day and Night Dry Eye Management
Research type
Research Study
Full title
Optive Brand for Day and Night Dry Eye Management. An open label CE marked eyedrops, bilateral, prospective, interventional post marketing clinical study.
IRAS ID
228407
Contact name
Kishan Patel
Contact email
Sponsor organisation
Allergan Pharmaceuticals International Ltd
Duration of Study in the UK
0 years, 6 months, 30 days
Research summary
Tear film composition differs greatly between the waking and sleeping periods. During the waking period the tear film is mostly consist of water (aqueous based film). In contrast, during sleep aqueous production stops and the tear film becomes a gel like structure dominated by mucous and oily layers. Dry eye complaints vary greatly in their level of severity and also in their daytime characteristics. Typically, dry eye complaints are less during the day and most marked either in the evening or upon waking, suggesting different potential mechanisms. With this, a different dry eye treatment should be considered for the waking and sleeping phases: aqueous supplementation and surface protection from the air during waking hours and gel supplementation during sleep; the latter being important for those dry eye sufferers with highest level of complaints upon waking.\nThe purpose of this study will be to evaluate the effect of a one-month treatment involving use of CE marked daytime eyedrops and night time gel combination to improve the overall dry eye symptomatology and ocular findings (better tears and less ocular surface damage) on moderate to severe dry eye sufferers.\nThe study will be a single site study in UK involving approximately 40 participants with moderate to severe dry eye symptomatology and signs of eye surface dryness. \nThe study will involve three clinic visits (enrollment, baseline/dispensing; one month follow-up/exit) over a five week period and completion of remote electronic questionnaires.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
17/SC/0312
Date of REC Opinion
20 Jun 2017
REC opinion
Favourable Opinion