Cross-linked Hyaluronic Acid and Coenzyme Q10 in the Treatment of Dry Eye

NCT03074344 | Completed

• 1 other identifier: AOUGMartino
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Dry eye disease (DED) is a common condition causing burden on visual function and reducing quality of life. Corticosteroids and/or cyclosporine eye drops are able to improve DED symptoms, however, side effects of immune suppression and cost lead patients often to suspend treatment. Consequently, is important to identify therapies alleviating DED symptoms. A randomized, controlled, single masked study, was performed in 40 patients affected by mild to moderate DED, to evaluate efficacy and safety of a collyrium based on cross-linked hyaluronic acid (XLHA) added with Coenzyme Q10 (CoQ10) in comparison to an eye drop considered a gold standard for tear substitutes, based on hyaluronic acid (HA) 0.15%. Methods: eye drops were administered four times a day for 90 days to enrolled subjects divided in two groups: group A treated with XLHA+CoQ10, group B treated with HA. Ocular Surface Disease Index (OSDI) questionnaire, visual acuity, intraocular pressure (IOP), fundus exam, tear break-up time (TBUT), corneal and conjunctival fluorescein staining, corneal esthesiometry, corneal confocal microscopy, were performed at different visits until the 90th day.

Conditions

Dry Eye Syndrome

Keywords

Dry Eye Syndrome; artificial tear; CoQ10; Hyaluronic acid

Outcome Measures

Primary Outcomes (2)

• Ocular Surface Disease Index (OSDI) questionnaire.

  The OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability. OSDI is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function. OSDI demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease.

  Up to 90 days.

• Corneal and conjunctival staining.

  Corneal and conjunctival staining of the ocular surface after instillation of vital dyes was developed to quantify epithelial surface damage in dry eye patients. Ocular surface fluorescein stain score was assessed 3 minutes after the instillation of fluorescein; a modified Oxford score was used: cornea and conjunctiva were scored separately from 0 to 5 (from 0 = none to 5 = extended areas of confluent stain), for the conjunctiva a mean for the scores from the nasal and temporal regions was used. The ocular surface was observed through a cobalt blue light and a Wratten #12 yellow filter.The difference among the scores obtained in each visit was calculated.

  Up to 90 days.

Secondary Outcomes (5)

• Visual acuity,

  Up to 90 days.

• Intraocular pressure (IOP).

  Up to 90 days.

• Fundus exam.

  Up to 90 days.

• Tear break-up time (TBUT).

  Up to 90 days.

• Corneal esthesiometry.

  Up to 90 days.

Study Arms (2)

XLHA+CoQ10

EXPERIMENTAL

XLHA+CoQ10 eye drop administered four times a day for 12 weeks (90 days).

Device: XLHA+CoQ10

Hyaluronic acid (HA)

ACTIVE COMPARATOR

Hyaluronic acid (HA) eye drop administered four times a day for 12 weeks (90 days).

Device: Hyaluronic acid (HA)

Interventions

XLHA+CoQ10 DEVICE

XLHA+CoQ10 for four times a day for 12 weeks.

Also known as: VisuXL®

XLHA+CoQ10

Hyaluronic acid (HA) DEVICE

Hyaluronic acid (HA) for four times a day for 12 weeks.

Hyaluronic acid (HA)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18 and 80 years,
• history of at least 3 months of dry eye symptoms referable to mild to moderate dry eye.

You may not qualify if:

• presence of any ocular disease, present or past, other than dry eye;
• previous ocular surgery,
• use of contact lens or topic treatments other than tear substitutes;
• presence of systemic diseases requiring a treatment with systemic drugs potentially interfering with tear productions;
• hypersensitivity to the active substance or to excipients;
• participation in a clinical trial during the 3 months prior to the beginning of the study,
• pregnancy or breast-feeding.

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Policlinico "G. Martino": lead

Related Publications (19)

• Benitez-Del-Castillo J, Labetoulle M, Baudouin C, Rolando M, Akova YA, Aragona P, Geerling G, Merayo-Lloves J, Messmer EM, Boboridis K. Visual acuity and quality of life in dry eye disease: Proceedings of the OCEAN group meeting. Ocul Surf. 2017 Apr;15(2):169-178. doi: 10.1016/j.jtos.2016.11.003. Epub 2016 Nov 30.

  PMID: 27913232 BACKGROUND

• Al-Saedi Z, Zimmerman A, Bachu RD, Dey S, Shah Z, Baugh R, Boddu SH. Dry Eye Disease: Present Challenges in the Management and Future Trends. Curr Pharm Des. 2016;22(28):4470-90. doi: 10.2174/1381612822666160614012634.

  PMID: 27296759 BACKGROUND

• Milner MS, Beckman KA, Luchs JI, Allen QB, Awdeh RM, Berdahl J, Boland TS, Buznego C, Gira JP, Goldberg DF, Goldman D, Goyal RK, Jackson MA, Katz J, Kim T, Majmudar PA, Malhotra RP, McDonald MB, Rajpal RK, Raviv T, Rowen S, Shamie N, Solomon JD, Stonecipher K, Tauber S, Trattler W, Walter KA, Waring GO 4th, Weinstock RJ, Wiley WF, Yeu E. Dysfunctional tear syndrome: dry eye disease and associated tear film disorders - new strategies for diagnosis and treatment. Curr Opin Ophthalmol. 2017 Jan;27 Suppl 1(Suppl 1):3-47. doi: 10.1097/01.icu.0000512373.81749.b7.

  PMID: 28099212 BACKGROUND

• The management of dry eye. Drug Ther Bull. 2016 Jan;54(1):9-12. doi: 10.1136/dtb.2016.1.0378.

  PMID: 26763598 BACKGROUND

• Schaumberg DA, Sullivan DA, Buring JE, Dana MR. Prevalence of dry eye syndrome among US women. Am J Ophthalmol. 2003 Aug;136(2):318-26. doi: 10.1016/s0002-9394(03)00218-6.

  PMID: 12888056 BACKGROUND

• Stevenson W, Chauhan SK, Dana R. Dry eye disease: an immune-mediated ocular surface disorder. Arch Ophthalmol. 2012 Jan;130(1):90-100. doi: 10.1001/archophthalmol.2011.364.

  PMID: 22232476 BACKGROUND

• The definition and classification of dry eye disease: report of the Definition and Classification Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007 Apr;5(2):75-92. doi: 10.1016/s1542-0124(12)70081-2.

  PMID: 17508116 BACKGROUND

• Baudouin C, Aragona P, Van Setten G, Rolando M, Irkec M, Benitez del Castillo J, Geerling G, Labetoulle M, Bonini S; ODISSEY European Consensus Group members. Diagnosing the severity of dry eye: a clear and practical algorithm. Br J Ophthalmol. 2014 Sep;98(9):1168-76. doi: 10.1136/bjophthalmol-2013-304619. Epub 2014 Mar 13.

  PMID: 24627252 BACKGROUND

• She Y, Li J, Xiao B, Lu H, Liu H, Simmons PA, Vehige JG, Chen W. Evaluation of a Novel Artificial Tear in the Prevention and Treatment of Dry Eye in an Animal Model. J Ocul Pharmacol Ther. 2015 Nov;31(9):525-30. doi: 10.1089/jop.2015.0042. Epub 2015 Aug 31.

  PMID: 26322539 BACKGROUND

• Stocker R, Bowry VW, Frei B. Ubiquinol-10 protects human low density lipoprotein more efficiently against lipid peroxidation than does alpha-tocopherol. Proc Natl Acad Sci U S A. 1991 Mar 1;88(5):1646-50. doi: 10.1073/pnas.88.5.1646.

  PMID: 2000375 BACKGROUND

• Fernandez MM, Afshari NA. Nutrition and the prevention of cataracts. Curr Opin Ophthalmol. 2008 Jan;19(1):66-70. doi: 10.1097/ICU.0b013e3282f2d7b6.

  PMID: 18090901 BACKGROUND

• Schiffman RM, Christianson MD, Jacobsen G, Hirsch JD, Reis BL. Reliability and validity of the Ocular Surface Disease Index. Arch Ophthalmol. 2000 May;118(5):615-21. doi: 10.1001/archopht.118.5.615.

  PMID: 10815152 BACKGROUND

• Sullivan BD, Whitmer D, Nichols KK, Tomlinson A, Foulks GN, Geerling G, Pepose JS, Kosheleff V, Porreco A, Lemp MA. An objective approach to dry eye disease severity. Invest Ophthalmol Vis Sci. 2010 Dec;51(12):6125-30. doi: 10.1167/iovs.10-5390. Epub 2010 Jul 14.

  PMID: 20631232 BACKGROUND

• Mandell RB. Slit lamp classification system. J Am Optom Assoc. 1987 Mar;58(3):198-201.

  PMID: 3571821 BACKGROUND

• Faulkner WJ, Varley GA. Corneal diagnostic techniques. In: Krachmer JH, Mannis MJ, Holland EJ, eds. Cornea. 2nd ed. Vol. 1 Philadelphia: Elsevier/Mosby; 2005:229-235.

  BACKGROUND

• Fabiani C, Barabino S, Rashid S, Dana MR. Corneal epithelial proliferation and thickness in a mouse model of dry eye. Exp Eye Res. 2009 Aug;89(2):166-71. doi: 10.1016/j.exer.2009.03.003. Epub 2009 Mar 17.

  PMID: 19298814 BACKGROUND

• Aragona P, Papa V, Micali A, Santocono M, Milazzo G. Long term treatment with sodium hyaluronate-containing artificial tears reduces ocular surface damage in patients with dry eye. Br J Ophthalmol. 2002 Feb;86(2):181-4. doi: 10.1136/bjo.86.2.181.

  PMID: 11815344 RESULT

• Barabino S, Rolando M, Nardi M, Bonini S, Aragona P, Traverso CE. The effect of an artificial tear combining hyaluronic acid and tamarind seeds polysaccharide in patients with moderate dry eye syndrome: a new treatment for dry eye. Eur J Ophthalmol. 2014 Mar-Apr;24(2):173-8. doi: 10.5301/ejo.5000355. Epub 2013 Sep 9.

  PMID: 24030535 RESULT

• Frei B, Kim MC, Ames BN. Ubiquinol-10 is an effective lipid-soluble antioxidant at physiological concentrations. Proc Natl Acad Sci U S A. 1990 Jun;87(12):4879-83. doi: 10.1073/pnas.87.12.4879.

  PMID: 2352956 RESULT

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Pasquale Aragona, MD

  Azienda Ospedaliera Universitaria Policlinico "G. Martino", Messina, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Visits were carried out in a blind fashion by investigators who were not aware to which group the patients belonged. The patients were allowed to know the brand name of the eye drops they were using.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Ophtalmology

Model Details: Randomised, single-masked, parallel-group comparative study.

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 8, 2017
• Study Start: May 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: November 1, 2016
• Last Updated: March 10, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share