Ignite Creation Date:
2024-05-06 @ 1:03 AM
Last Modification Date:
2024-10-26 @ 10:58 AM
Study NCT ID:
NCT01713179
Status:
COMPLETED
Last Update Posted:
2016-08-30
First Post:
2012-10-22
Brief Title:
Effects of Oral Mucolytics on Tear Film and Ocular Surface
Sponsor:
Hallym University Kangnam Sacred Heart Hospital
Organization:
Hallym University Kangnam Sacred Heart Hospital
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Ambroxol is a metabolite of bromhexine and possesses mucokinetic and secretolytic properties that are also found in mucolytic agents1 Ambroxol has been used for decades for the treatment of respiratory disorders associated with excessive mucus including chronic inflammatory pulmonary conditions bronchitis and pneumonia23 The drug changes the biophysical properties of secretions by degrading the mucin polymers deoxyribonucleic acid fibrin in airway secretions and by generally decreasing viscosity4 In addition ambroxol increases cyclic nucleotide cAMP or cGMP5 which can theoretically increase tear secretion6 Many systemic medications such as antihistamines antidepressants diuretics acne drugs and certain blood pressure medicines can cause or exacerbate a dry eye78 On the other hand several topical medications including mucolytics such as ambroxol and bromhexine may be used to treat tear-deficient dry eyes by promoting lacrimal gland function9 However the effects of mucoactive agents on the tear film have not been investigated systemically and mucoactive agents may have a disturbing effect on the tear film because they modify mucin1011 The tear film is composed of 3 unique layers including the outermost lipid layer the middle aqueous layer and the innermost mucus layer this structure enables it to perform many functions12 The lipid layer acts as a barrier to prevent tear film evaporation and the aqueous layer supplies oxygen and important nutrients to the cornea13 The mucin layer secreted mostly by conjunctival goblet cells coats the corneal surface rendering it hydrophilic and anchors the tear film to the corneal surface14 Deficiencies in the amount of tear production or alteration in tear composition can lead to ocular surface disease15 Although many studies have focused on aqueous-deficient dry eye syndrome16-18 the effect of mucin layer defects on the tear film has not been thoroughly studied Furthermore very few reports have determined the effects of oral mucolytic agents on the tear film and ocular surfaces although a study has reported that filamentary keratopathy was treated with debridement of filaments and application of topical mucolytic agents such as acetylcysteine eyedrops In the present study we investigated the effects of oral ambroxol on tear film and ocular surface
Reference
1 Malerba M Ragnoli B Ambroxol in the 21st century pharmacological and clinical update Expert Opin Drug Metab Toxicol 200841119-1129
2 Rubin BK Mucolytics expectorants and mucokinetic medications Respir Care 200752859-865
3 Rogers DF Mucoactive agents for airway mucus hypersecretory diseases Respir Care 2007521176-1193
4 Gupta PR Ambroxol - Resurgence of an old molecule as an anti-inflammatory agent in chronic obstructive airway diseases Lung India 20102746-48
5 Anfossi G Russo I Massucco P et al Adenosine increase human platelet levels of cGMP through nitric oxide possible role in its antiaggregating effect Thromb Res 200210571-78
6 Gilbard JP Rossi SR Heyda KG et al Stimulation of tear secretion by topical agents that increase cyclic nucleotide levels Invest Ophthalmol Vis Sci 1990311381-1388
7 Gayton JL Etiology prevalence and treatment of dry eye disease Clin Ophthalmol 20093405-412
8 Terry MA Dry eye in the elderly Drugs Aging 200118101-107
9 Calonge M The treatment of dry eye Surv Ophthalmol 200145227-239
10 Yamada T Takemura Y Niisato N et al Action of N-acylated ambroxol derivatives on secretion of chloride ions in human airway epithelia Biochem Biophys Res Commun 2009380586-590
11 Hasegawa I Niisato N Iwasaki Y et al Ambroxol-induced modification of ion transport in human airway Calu-3 epithelia Biochem Biophys Res Commun 2006343475-482
12 Antti H Tuulikki S Matej O Human tear fluid lipidome from composition to function PLoS One 20116e19553
13 Ohashi Y Dogru M Tsubota K Laboratory findings in tear fluid analysis Clin Chim Acta 200639617-28
14 Davidson HJ Kuonen VJ The tear film and ocular mucins Vet Ophthalmol 2004771-77
15 Bhavsar AS Bhavsar SG Jain SM A review on recent advances in dry eye pathogenesis and management Oman J Ophthalmol 2011450-56
16 Patel S Farrell J Blades KJ et al The value of a phenol red impregnated thread for differentiating between the aqueous and non-aqueous deficient dry eye Ophthalmic Physiol Opt 199818471-476
17 Lin H Li W Dong N et al Changes in corneal epithelial layer inflammatory cells in aqueous tear-deficient dry eye Invest Ophthalmol Vis Sci 201051122-128
18 Yokoi N Yamada H Mizukusa Y et al Rheology of tear film lipid layer spread in normal and aqueous tear-deficient dry eye Invest Ophthalmol Vis Sci 2008495319-5324
Reference
1 Malerba M Ragnoli B Ambroxol in the 21st century pharmacological and clinical update Expert Opin Drug Metab Toxicol 200841119-1129
2 Rubin BK Mucolytics expectorants and mucokinetic medications Respir Care 200752859-865
3 Rogers DF Mucoactive agents for airway mucus hypersecretory diseases Respir Care 2007521176-1193
4 Gupta PR Ambroxol - Resurgence of an old molecule as an anti-inflammatory agent in chronic obstructive airway diseases Lung India 20102746-48
5 Anfossi G Russo I Massucco P et al Adenosine increase human platelet levels of cGMP through nitric oxide possible role in its antiaggregating effect Thromb Res 200210571-78
6 Gilbard JP Rossi SR Heyda KG et al Stimulation of tear secretion by topical agents that increase cyclic nucleotide levels Invest Ophthalmol Vis Sci 1990311381-1388
7 Gayton JL Etiology prevalence and treatment of dry eye disease Clin Ophthalmol 20093405-412
8 Terry MA Dry eye in the elderly Drugs Aging 200118101-107
9 Calonge M The treatment of dry eye Surv Ophthalmol 200145227-239
10 Yamada T Takemura Y Niisato N et al Action of N-acylated ambroxol derivatives on secretion of chloride ions in human airway epithelia Biochem Biophys Res Commun 2009380586-590
11 Hasegawa I Niisato N Iwasaki Y et al Ambroxol-induced modification of ion transport in human airway Calu-3 epithelia Biochem Biophys Res Commun 2006343475-482
12 Antti H Tuulikki S Matej O Human tear fluid lipidome from composition to function PLoS One 20116e19553
13 Ohashi Y Dogru M Tsubota K Laboratory findings in tear fluid analysis Clin Chim Acta 200639617-28
14 Davidson HJ Kuonen VJ The tear film and ocular mucins Vet Ophthalmol 2004771-77
15 Bhavsar AS Bhavsar SG Jain SM A review on recent advances in dry eye pathogenesis and management Oman J Ophthalmol 2011450-56
16 Patel S Farrell J Blades KJ et al The value of a phenol red impregnated thread for differentiating between the aqueous and non-aqueous deficient dry eye Ophthalmic Physiol Opt 199818471-476
17 Lin H Li W Dong N et al Changes in corneal epithelial layer inflammatory cells in aqueous tear-deficient dry eye Invest Ophthalmol Vis Sci 201051122-128
18 Yokoi N Yamada H Mizukusa Y et al Rheology of tear film lipid layer spread in normal and aqueous tear-deficient dry eye Invest Ophthalmol Vis Sci 2008495319-5324
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None