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References

Home Page References

  1. Impact Rx – May 2020.
  2. Data on file. Results of an independent survey among South African Optometrists’ reflecting 90% confidence level of the total population. November 2018.
  3. Reindel W, et al. Meta-analysis of the ocular biocompatibility of a new multipurpose lens care system. Clin Ophthalmol 2013;7:2051-6.
  4. Singh A, et al. A hyaluronic acid-binding contact lens with enhanced water retention. Cont Lens Anterior Eye. 2015 Apr;38(2):79-84.
  5. Venkatesh S. Biotrue multipurpose solution: bringing inspiration to lens care. Optician. 09/2010.
  6. Data on file. IMS TPM 21L. PREPARAT. CONTACT LENSES. May 2020.

Artelac

  1. Scheuer CA, et al. Retention of conditioning agent hyaluronan on hydrogel contact lenses. Contact Lens & Anterior Eye 2010,33(1S),2-6.
  2. Dry Eye, facts about [NEI Health Information] [Cited 2014 May 12]; Available from URL: https://www.nei.nih.gov/health/dryeye/dryeye.asp.
  3. Bartlett JD, et al. Diagnostic & treatment algorithms for ocular surface disease states. Dry Eye. Part three of an ongoing series. New paradigms in the understanding and management of dry eye. Review of Optometry October 2011:1-12.
  4. Yao W, et al. Dry Eye Syndrome: An update in office management. Am J Med 2011;124:1016-1018.
  5. Dry Eye Syndrome. Available at: http://www.allaboutvision.com/conditions/dryeye.htm. [Accessed May 26, 2014].
  6. Roach, L. Rethinking meibomian gland dysfunction: How to spot it, stage it and treat it. American Academy of Ophthalmology. Available at https://www.aao.org/eyenet/article/rethinking-meibomian-gland-dysfunction-how-to-spot?julyaugust-2011 [Accessed August 1, 2017].
  7. Meibomian Gland Dysfunction and Treatment. American Association for Pediatric Ophthalmology and Strabismus. https://www.aapos.org/terms/conditions/141 [Accessed August 1, 2017].
  8. Zheng X, et al. In vitro efficacy of ocular surface lubricants against dehydration 2013 Sep;32(9):1260-4.
  9. Hyaluronic Acid. Web MD. Available at: http://www.webmd.com/vitamins-supplements/ingredientmono-1062-hyaluronic%20acid.aspx?activeingredientid=1062& [Accessed May 23, 2017].
  10. Reindel W, et al. Meta-analysis of the ocular biocompatibility of a new multipurpose lens care system. Clin Ophthalmol. 2013;7:2051-6.

Artelac Allergy

  1. Sánchez-Hernández MC, et al. Consensus document on allergic conjunctivitis (DECA). J Investig Allergol Clin Immunol. 2015;25(2):94-106.
  2. Werkhäuser N, et al. Treatment of Allergic Rhinitis with Ectoine containing nasal spray and eye drops in comparison with Azelastine containing nasal spray and eye drops or with
  3. Scheuer CA, et al Retention of conditioning agent hyaluronan on hydrogel contact lenses. Contact Lens & Anterior Eye 2010;33(1S),2-6
  4. Extremolytes. Available online https://www.bitop.de/en/extremolytes [Accessed January 17, 2019].
  5. Eichel A, et al. Meta-analysis of the efficacy of Ectoine nasal spray in patients with allergic rhinoconjunctivitis. J Allergy (Cairo). 2014;2014:292545.

Eye Nutrition

  1. Yao W, et al. Dry Eye Syndrome: An update in officce management. Am J Med 2011;124:1016-1018.
  2. Bartlett JD, et al. Diagnostic & Treatment Algorithms for Ocular Surface Disease States. Dry Eye. Part three of an ongoing series. New paradigms in the understanding and management of dry eye. Review of Optometry. October 2011:1-12.
  3. Mertzanis P, et al. The relative burden of dry eye in patients’ lives: comparisons to a U.S. normative sample. Invest Ophthalmol Vis Sci. 2005 Jan;46(1):46-50.
  4. National Institutes of Health. National Eye Institute website. Facts about age-related macular degeneration. (http://www.nei.nih.gov/health/maculardegen/armd_facts.asp) Accessed May 2, 2011.
  5. Ambati J, Ambati BK, Yoo SH, Ianchulev S, Adamis AP. Age-related macular degeneration: Etiology, pathogenesis, and therapeutic strategies. Surv Ophthalmol. 2003;48(3):257–293.
  6. Graham, RH. There’s nothing fi shy about omega-3 fatty acids for dry eye syndrome. Medscape Ophthalmology. Available at http://www.medscape.com/viewarticle/707984_2. [Accessed January 13,2014].
  7. Omega-3 Fatty Acids. Available at: http://umm.edu/health/medical/altmed/supplement/omega3-fatty-acids. [Accessed May 26, 2014].
  8. Rasmussen HM, et al. Nutrients for the aging eye. Clinical Interventions in Aging 2013; 8:741–748.

Biotrue Multipurpose Solution

  1. Data on file. Results of an independent survey among South African Optometrists’ reflecting 90% confidence level of the total population. November 2018.
  2. Venkatesh S. Biotrue multipurpose solution: bringing inspiration to lens care. Optician. 09/2010.
  3. Reindel W, et al. Meta-analysis of the ocular biocompatibility of a new multipurpose lens care system. Clin Ophthalmol 2013;7:2051-6.
  4. Singh A, et al. A hyaluronic acid-binding contact lens with enhanced water retention. Cont Lens Anterior Eye. 2015 Apr;38(2):79-84.
  5. Scheuer CA, et al. Retention of conditioning agent hyaluronan on hydrogel contact lenses. Contact Lens & Anterior Eye 2010,33(1S),2-6.
  6. Zheng X, et al. In vitro efficacy of ocular surface lubricants against dehydration 2013 Sep;32(9):1260-4.
  7. Wright EA, et al. Preservation of human tear protein structure and function by a novel contact lens multipurpose solution containing protein-stabilizing agents. Eye Contact Lens. 2012 Jan;38(1):36-42.

ReNu Multipurpose Solutions

  1. Data on file. IMS TPM 21L. PREPARAT. CONTACT LENSES. May 2020.

Ultra

  1. Steffen R, et al. Clinical performance of samfilcon A silicone hydrogel contact lenses. Contact Lens Spectrum. 2014;29(Special Edition13):30-38.
  2. Wygladacz K, et al. Breaking the Cycle of Discomfort. Contact Lens Spectrum. 2014;29(Special Edition13):23-28.
  3. Reindel W, et al. Performance Of A Unique Silicone Hydrogel Lens Across The Recommended Wear Cycle.Poster presented at the American Academy of Optometry Annual Meeting, Anaheim, CA, November 2016.
  4. Vogt AKS. A New Contact Lens Option for Presbyopic Patients – Innovation in design and metrology guided the creation of this multifocal contact lens. Contact Lens Spectrum, March 2014; 1-6.
  5. ULTRA Comfort Experience™ for Presbyopia Data Analysis Phase 1 + 2. 2017.
  6. Rah MJ, et al. Interest and Acceptance of a New Contact Lens Technology in Today’s Practice. Poster presented at the American Optometric Association Annual Meeting, Seattle, WA, June 2015.
  7. DeNaeyer, G. Bausch+Lomb ULTRA® Contact Lenses with MoistureSeal® Technology.

*Should you require a printed copy of the IFU please contact us

Biotrue ONEday

*Competitor Materials compared included: Nelfilcon A, Etafilcon A, Somofilcon A, Senofilcon A and Delefilcon A.
**83.9% of subjects agreed that the study lenses delivered comfortable vision throughout the day.

  1. Bausch + Lomb data on file- Study #700- Final Study Report
  2. Bausch + Lomb data on file- Daniel Hook, 2011.
  3. Bausch + Lomb data on file- Robert b. Steffen, 2012.
  4. Osbert Chan, P.D. Optom, Ph.D. and Tomy Lo, B.Sc (Optom), Ph.D. A Study to Evaluate the Tear Stability in Terms of Non-Invasive Tear Breakup Time (NITBUT) of Daily Disposable Soft Contact Lenses after 10 Hours of Lens Wear.
  5. Pence N. New introductions in the daily disposable modality. Cont Lens Spec. 2012 Aug;27:19.
  6. Bausch + Lomb data on file- Study #LDR165005A- Lens Design Report.
  7. Bausch + Lomb data on file- Study #828:15-003- Clinical Study Report.
  8. Bausch + Lomb data on file- Report #WRD-16-050R- Spherical Aberration Level Comparison of Competing Daily Disposable Toric Lenses Across the SKU Range.
  9. Vogt AKS. A New Contact Lens Option for Presbyopic Patients – Innovation in design and metrology guided the creation of this multifocal contact lens. Contact Lens Spectrum, March 2014; 1-6.
  10. Scheafer, J, et al. Evaluation of surface water characteristics of novel daily disposable contact lens material, using refractive index shifts after wear. Clin Ophthalmol 2015;9:1973-9.

*Should you require a printed copy of the IFU please contact us

PureVision 2

  1. Cairns, G. Better visual acuity with aspheric optics. Optician, 2011 (April):29-30.
  2. Koh, S, et al. Efficacy of spherical aberration correction based on contact lens power. Cont Lens Anterior Eye. 2014 Jan 14. pii: S1367-0484(13)00334-2.
  3. Vogt AKS. A New Contact Lens Option for Presbyopic Patients – Innovation in design and metrology guided the creation of this multifocal contact lens. Contact Lens Spectrum, March 2014; 1-6.
  4. Ozkan J, et al. Lens parameter changes under in vitro and ex vivo conditions and their effect on the conjunctiva. Cont Lens Anterior Eye. 2013 Aug;36(4):171-5

*Should you require a printed copy of the IFU please contact us

Dry Eye Syndrome

  1. Scheuer CA, et al. Retention of conditioning agent hyaluronan on hydrogel contact lenses. Contact Lens & Anterior Eye 2010,33(1S),2-6.
  2. Zheng X, et al. In vitro efficacy of ocular surface lubricants against dehydration 2013 Sep;32(9):1260-4.
  3. Reindel W, et al. Meta-analysis of the ocular biocompatibility of a new multipurpose lens care system. Clin Ophthalmol. 2013;7:2051-6.
  4. Hyaluronic Acid. Web MD. Available at: http://www.webmd.com/vitamins-supplements/ingredientmono-1062-hyaluronic%20acid.aspx?activeingredientid=1062& [Accessed May 23, 2017].
  5. Impact Rx – May 2020.

Applicant/Distributed by: Soflens(Pty) Ltd. Reg. No.: 1968/011787/07.

Proprietary name: Artelac® Advanced Lipids Eye Drops. Contains 2 mg carbomer, medium chain triglycerides. Preservative: Cetrimide (10g multi-dose only).

Proprietary name: Artelac® Advanced Eye Gel. Contains 2 mg carbomer, medium chain triglycerides. Preservative: Cetrimide. Proprietary name: Artelac® Intense Rebalance Eye Drops. Contains 0,15% hyaluronic acid (as sodium hyaluronate), 0,5% polyethylene glycol 8000, vitamin B12. Preservative: Oxyd® (a gentle preservative that converts to water, oxygen and salt at the surface of the eye in the 10ml multi-dose unit only).

Proprietary name: Artelac® Splash Eye Drops. Contains 0,24% hyaluronic acid (as sodium hyaluronate) in the 10ml multi-dose unit and 0,2% hyaluronic acid (as sodium hyaluronate)in the single dose units. Both the 10ml multi-dose and single dose units are preservative free.

Proprietary name: Artelac® Moisture Eye Drops. Contains 0,32% hypromellose. Preservative:Cetrimide (10ml multi-dose only).

Scheduling status: S0 Proprietary name and dosage form: Ocuvite Complete soft gel capsules. Composition: Each soft gel capsule contains fish oil rich in DHA 507,7 mg: of which DHA 180 mg and total omega-3 300 mg, Lutein 5 mg, zeaxanthin 1 mg, vitamin C 90 mg, vitamin E 15 mg, zinc 7,5 mg.

Scheduling status: S0 Proprietary name and dosage form: Ocuvite Lutein tablets. Composition: Each tablet contains Lutein 6mg, Zeaxanthin 0,5 mg, Vitamin E 8,8 mg, Vitamin C 60 mg, Zinc 5 mg and 20μg Selenium.

Scheduling status: S0 Proprietary name and dosage form:  Ocuvite Complete sachets powder. Composition: Each sachet contains omega-3 DHA 150 mg, Lutein 10 mg, zeaxanthin 2 mg, vitamin C 180mg, vitamin E 30 mg, zinc 15 mg.

Scheduling status: S0 Proprietary name and dosage form:  CEBROLUX™ NF powder for oral solution. Composition: Each 3g sachet contains: Citicoline (Cognizin®) 250 mg, Vitamin C 60 mg, Vitamin B3 12 mg, Vitamin E 8,2 mg, Zinc 6,25 mg, Vitamin B5 4,5 mg, Vitamin B6 1,05 mg, Vitamin B2 1,05 mg, Vitamin B1 0,83 mg, Vitamin A 600 μg, Folic acid150 μg, Biotin 37,5 μg and Vitamin B12 1,875 μg. CEBROLUX™ is a trademark of Bausch & Lomb Incorporated or its affiliates. COGNIZIN® is a registered trademark of KYOWA HAKKO BIO CO., LTD.

Proprietary name: Biotrue® Multi-Purpose Solution. Contains: Hyaluronan, sulfobetaine, poloxamine and preserved with a dual disinfection system (polyaminopropyl biguanide 0,00013 % and polyquaternium 0,0001 %).

Proprietary name: Easysept™ 3 % Hydrogen Peroxide. Contains: 3 % Hydrogen Peroxide solution with a phosphonic acid stabiliser, sodium chloride and phosphate buffers.

Scheduling status: S0 Proprietary name and dosage form: Bausch & Lomb ReNu® MultiPlus Solution. Composition: Each ml contains Polyaminopropyl biguanide (Dymed™) 0,0010 mg, Hydroxyalkylphosphonate 0,30 mg and Disodium edetate(preservative) 0,11 % m/v. Pharmacological classification: A 34 Contact lens solution. Reg. No.: 33/34/0484.

Scheduling status: S0 Proprietary name and dosage form: Bausch & Lomb ReNu® Multi-Purpose Solution. Composition: Each ml contains Polyaminopropyl biguanide(Dymed™) 0,0005 mg and Disodium edetate (preservative) 0,11 % m/v. Pharmacological classification: A 34 Contact lens solution. Reg. No.: X/34/239.

Proprietary name: Boston® Simplus Multi-Action Solution. Contains: Poloxamine, hydroxyalkylphosphonate, boric acid, sodium borate, sodium chloride and hydroxypropylmethyl cellulose, Glucam and preserved with chlorhexidine gluconate (0,003 %) and polyaminopropyl biguanide (0,0005 %).

Proprietary name: Bausch & Lomb Boston® ADVANCE Cleaner. Contains: Alkyl sulphate surfactant (8,0 % w/v), other ingredients: sodium chloride, sodium phosphate, non ionic alcohol surfactant, silica gel suspension; with titanium dioxide.

Proprietary name: Bausch & Lomb Boston® ADVANCE Conditioning Solution. Contains: Polyaminopropyl biguanide (0,0005 % w/v), chlorhexidine gluconate (0,003 % w/v), disodium edetate (0,05 % w/v); other: salts and buffering agents, polyquaternium 10, cellulosic viscosifier, polyvinyl alcohol and derivatised polyethylene glycol.

Proprietary name: Bausch+Lomb Sight Savers®. Contains: Isopropyl Alcohol.

Proprietary name: Bausch+Lomb ULTRA® (samfilcon A) Contact Lens.

Proprietary name: Bausch + Lomb Biotrue® ONEday (nesofilcon A) Soft (Hydrophilic) Contact Lens.

Proprietary name: Bausch + Lomb PureVision®2 (balafilcon A) Visibility Tinted Contact Lens.

Proprietary name: Bausch + Lomb PureVision® (balafilcon A) Visibility Tinted Contact Lens.

Proprietary name: Bausch + Lomb SofLens® 38 (polymacon) Visibility Tinted Contact Lens.

Proprietary name: Bausch + Lomb SofLens® 59 (hilafilcon B) Visibility Tinted Contact Lens.

Proprietary name: Bausch + Lomb SofLens® Multi-Focal (polymacon) Visibility Tinted Contact Lens.

Proprietary name: Bausch + Lomb SofLens® Toric (alphafilcon A) Visibility Tinted Contact Lens.

Proprietary name: Bausch + Lomb SofLens® daily disposable (hilafilcon B) Visibility Tinted Contact Lens.

Proprietary name: Bausch + Lomb SofLens® daily disposable Toric (hilafilcon B) Visibility Tinted Contact Lens.

Proprietary name: Artelac® Allergy Eye Drops. Contains:0,24 % hyaluronic acid (as sodium hyaluronate), 2 % Ectoin®. Preservative free.

For full prescribing information, refer to instructions for use or professional information as approved by the South African Health Products Regulatory Authority (SAHPRA). Further information is available on request from Bausch + Lomb.