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With the onset of the 21st century, there has been a veritable explosion of ophthalmic research. Eyesight, in keeping with its leadership position in the delivery of state-of-the-art eye care, has made a significant commitment to assist in the discovery and delivery of new ocular therapies as well as to insure that these new developments become available to our patients as soon as possible.
From new antibiotics for conjunctivitis and novel treatments for dry eye syndrome, to the latest emerging computer assisted techniques for LASIK and novel combination treatments for age related macular degeneration, Eyesight has demonstrated its ability to conduct clinical research studies in several subspecialty areas of ophthalmology. An updated listing of past and current clinical studies is included within this section. If you have an interest in participating in any of the listed studies, or if you have any questions regarding further details, please contact the study coordinator listed for that study.
Study
A phase II multicenter, randomized, double-masked, placebo-controlled, dose-comparison study of the safety and efficacy of Fenretinide in the treatment of geographic atrophy in subjects with age-related macular degeneration. The primary efficacy endpoint will be the growth rate of the total aggregated area of the GA lesions. The secondary analysis will consider the growth rate.
Study contact: Sunny Kallay
Status: Closed
Principle investigator: Richard Chace
Study
A phase III randomized, double-masked, parallel-assignment study of intravitreal bevasiranib sodium administered every 8 or 12 weeks as maintenance therapy following 3 injections of Lucentis compared with Lucentis mono-therapy every 4 weeks in patients with Exudative Age-Related Macular Degeneration (COBALT). This research study is to evaluate the efficacy of intravitreal bevasiranib sodium as maintenance therapy for age-related macular degeneration following initiation of anti-VEGF therapy with 3 doses of Lucentis.
Study contact: Sunny Kallay
Status: Open Enrollment
Principle investigator: Richard Chace
Study
A randomized, double-masked, 3 arm, parallel-group, comparative study to evaluate the clinical and anti-microbial efficacy and safety of AzaSite Plus compared to AzaSite alone and Dexamethasone alone in the treatment of subjects with Blepharoconjunctivitis.
Study contact: Sunny Kallay
Status: Open Enrollment
Principle investigator: Warren Goldblatt
Study
A randomized, multi-centered, double-masked, parallel-group clinical safety and efficacy evaluation of Loteprednol-Etabonate ophthalmic ointment (LE) 0.5% to vehicle (placebo) for the treatment of inflammation following cataract surgery. The primary efficacy end point for this study is the proportion of subjects with complete resolution of anterior chamber cells and flare.
Study contact: Sunny Kallay
Status: Open Enrollment
Principle investigator: Timothy Peters
Study
Efficacy and safety of ecabet ophthalmic solution (2.83%) for the treatment of dry eye syndrome. This research study is to evaluate the safety and effectiveness of a new drug (in eye drop form) to treat moderate dry eye disease.
Study contact: Teri Sandven – 603-436-1773
Status: Closed
Principal Investigator: Richard Chace, MD
Study
An open label, randomized, three visit pilot study to evaluate the bioavailability of a commercially available antibiotic and steroid combination of ophthalmic suspension (TobraDex (tobramycin and dexamethasone ophthalmic suspension) Alcon Laboratories, Inc.) in subjects undergoing bilateral cataract surgery. This research study is to determine a dose-response curve of dexamethasone concentration in the human aqueous humor after a single dose is applied topically prior to cataract surgery.
Study contact: Teri Sandven – 603-436-1773
Status: Closed
Principal Investigator: Richard Chace, MD
Study
Efficacy and safety of ecabet sodium solution (2.83% and 3.70%) for the treatment of Dry Eye Syndrome. This research study is to see how safe and effective an investigational new drug (in an eye drop form) will be to treat moderate dry eye disease (also known as Keratoconjunctivitis Sicca (KCS), dry eye syndrome)
Study contact: Teri Sandven – 603-436-1773
Status: Closed
Principal Investigator: Richard Chace, MD
Study
A multi-center, randomized, double masked, bioequivalent study of tobramycin and prednisolone acetate (0.3 / 1.0% ISTA) ophthalmic suspension compared to Pred Forte (1% prednisolone acetate, Allergan) ophthalmic suspension. This research study is to determine if the steroid, (1% prednisolone acetate) component of a combined tobramycin prednisolone acetate formulation has equal penetration into the aqueous humor for the eye as prednisolone acetate 1% (Pred Forte 1%).
Study contact: Teri Sandven – 603-436-1773
Status: Closed
Principal Investigator: Richard Chace, MD
Study
A safety and efficacy evaluation of AL-12959A ophthalmic solution versus AL-12959A vehicle ophthalmic solution for the treatment of Dry Eye following refractive surgery. This research study is to see how safe and effective an investigational new drug (in an eye drop form) will be to treat dry eye signs and symptoms in patients who undergo refractive surgery.
Study contact: Kimberly Quinones – 603-501-5000
Status: Closed
Principal Investigator: N. Timothy Peters, MD
Study
An evaluation of AL-12959A ophthalmic solution compared to AL-12959A vehicle ophthalmic solution for the treatment of Dry Eye in this controlled adverse environment (CAE) model. This research study is to see how safe and effective an investigational new drug (in an eye drop form) will be to treat dry eye syndrome (also known as Keratoconjunctivitis Sicca, KCS) utilizing an adverse environment test room.
Study contact: Teri Sandven – 603-436-1773
Status: Closed
Principal Investigator: Richard Chace, MD
Study
Evaluation of the Bausch & Lomb Keracor 4.11A US software and multi-use Zyoptix Personalized treatment card. This research study is designed to evaluate the introduction of multi-use treatment cards to meet user needs for a faster, easier, more convenient LASIK treatments.
Study contact: Kimberly Quinones – 603-501-5000
Status: Closed
Principal Investigator: N. Timothy Peters, MD
Study
Evaluation of the Bausch & Lomb Accuglide Keratome Blade manufactured with a modified cleaning process. This research study is to evaluate the subjective feedback from surgeons using accuglide keratome blades manufactured with a modified cleaning process with attempts to:
Expose the blade to less harsh chemicals
Improve blade appearance and surface quality while maintaining blade dimensions to produce equivalent quality flaps and stromal beds compared to blades made by the standard manufacturing process.
Study contact: Kimberly Quinones – 603-501-5000
Status: Closed
Principal Investigator: N. Timothy Peters, MD
Study
A prospective, bilateral eye study of the Bausch & Lomb Softport Advanced Optics (AO) aspheric IOL (model LI61AO) monovision study. This research study is to evaluate the pre and post-operative clinical and subjective outcomes for subjects bilaterally implanted for distance correction in the dominant eye and for near vision in the fellow eye at the nominal reading distance following cataract surgery.
Study contact: Kimberly Quinones – 603-501-5000
Status: Closed
Principal Investigator: N. Timothy Peters, MD
Study
A prospective multi-center trial to evaluate the safety and effectiveness of the Bausch & Lomb Technolas 217Z Zyoptix system for personalized LASIK vision correction with Treatment planner customized treatment calculation software when used for wavefront guided hyperopia and hyperopic astigmatism. This research study is to evaluate the safety and effectiveness of a new customized computer guided LASIK treatment for farsightedness (hyperopia) and farsightedness with astigmatism
Study contact: Kimberly Quinones – 603-501-5000
Status: Closed
Principal Investigator: N. Timothy Peters, MD
Study
A randomized, double masked parallel group, multi-center dose finding comparison of the safety and efficacy of ASI-001A 0.5 μg/day and ASI-001B 0.2 μg/day fluocinolone acetonide intravitreal inserts to show injection in subjects with diabetic macular edema. (FAME). This research study is to evaluate the safety and effectiveness as well as the most appropriate dose of an intravitreally injected, sustained release preparation of steroid, for the treatment of macular edema secondary to diabetic retinopathy.
Study contact: Sunny Kallay – 603-436-1773
Status: Closed
Principal Investigator: Richard Chace, MD
Study
Registry of Visudyne age-related macular degeneration therapy. This research study is a retrospective data analysis of patients with exudative (wet) macular degeneration treated with photodynamic therapy with Visudyne as well as concomitant anti-VEGF intravitreal medication injections (AVASTIN, LUCENTIS, Macugen)
Study contact: Sunny Kallay – 603-436-1773
Status: Closed
Principal Investigator: Richard Chace, MD
Study
A study to evaluate the clinical and microbial efficacy of 0.6% ISV-403 compared to vehicle in the treatment of bacterial conjunctivitis. The research study is to determine the effectiveness of a new antibiotic eye drops for the treatment of bacterial conjunctivitis.
Study contact: Teri Sandven – 603-436-1773
Status: Closed
Principal Investigator: Richard Chace, MD
Study
Patient dosing with Travatan using the Travatan dosing aid. This research study is to assess physician and patient perceptions of the Travatan dosing aid, a device designed to remind patients when to dose their glaucoma medications.
Study contact: Teri Sandven – 603-436-1773
Status: Closed
Principal Investigator: Richard Chace, MD
Study
An assessment of higher order aberrations and contract sensitivity testing in post-op cataract patients – comparing the AO lens and SE lens implants after cataract surgery
Study contact: Kimberly Quinones – 603-501-5000
Status: Closed
Principal Investigator: N. Timothy Peters, MD
Study
Compare clinical outcomes of average LASIK flap thickness utilizing Bausch & Lomb Hansatome vs. Zyoptix XP Microkeratome
Study contact: Kimberly Quinones – 603-501-5000
Status: Closed
Principal Investigator: N. Timothy Peters, MD
Study
To evaluate patient outcomes after custom ablation with an approved LASIK system but omitting the dilated Zywaves that were taken on each patient, thereby removing any possibility of pupil shift errors.
Study contact: Kimberly Quinones – 603-501-5000
Status: Closed
Principal Investigator: N. Timothy Peters, MD
Study
The QUEST Registry will capture retrospective data for patients with CNV (choroidal neovascularization) due to AMD (age related macular degeneration) who have received Visudyne combination therapy with either Avastin or Lucentis, or an anti-VEGF and an intravitreal steroid (triple therapy).
Study contact: Sunny Kallay – 603-436-1773
Status: Closed
Principal Investigator: Richard Chace, MD
Study
Reduced-Fluence Visudyne Anti-VEGF Dexamethasone In Combination for AMD Lesions (RADICAL). A multi-center, randomized, single masked study comparing reduced-fluence Visudyne-Lucentis combination therapies and Lucentis monotherapy in patients with CNV (choroidal neovascularization) secondary to AMD (age related macular degeneration).This research study is to determine if combination therapy reduces retreatment rates compared with Lucentis monotherapy while maintaining similar vision outcomes.
Study contact: Sunny Kallay – 603-436-1773
Status: Open Enrollment
Principal Investigator: Richard Chace, MD
Study
To evaluate the clinical performance of the EC-3 Hydrophobic Acrylic Posterior Chamber Aphakic Intraocular Lens (IOL) following primary implantation for the visual correction of aphakia when the cataractous lens has been removed by phacomulsification.
Study contact: Kimberly Quinones – 603-501-5000
Status: Closed
Principal Investigator: N.Timothy Peters
Study
Assessment of Safety of Intravitreal POT-4 (ASAP) for patients with Neovascular Age-Related Macular Degeneration. To provide initial safety and tolerability information for a larger Phase II study of intravitreal POT-4 for the treatment of patients with AMD.
Study contact: Sunny Kallay – 603-436-1773
Status: Open Enrollment
Principal Investigator: Richard Chace
Study
Intravitreal Ranibizumab or Triamcinolone Acetonide in Combination with Laser Photocoagulation for Diabetic Macular Edema. To evaluate the safety and efficacy of
(1) intravitreal anti-VEGF treatment alone verses (2) intravitreal anti-VEGF treatment in combination with focal laser photocoagulation verses (3) intravitreal cortcosteroids in combination with focal laser photocoagulation in eyes with center-involved DME.
Study contact: Sunny Kallay – 603-436-1773
Status: Open Enrollment
Principal Investigator: Richard Chace
Study
Intravitreal Ranbizumab or Triamcinolone Acetonide as Adjunctive Treatment to Panretinal Photocoagulation for Proliferative Diabetic Retinopathy. To determine whether intravitreal injection of an anti-VEGF drug or an intravitreal injection of a corticosteroid can reduce the risks of visual acuity impairment that can occur following PRP and increase the chances of at least short term visual acuity improvement in eyes with evidence of center-involved macular edema that are undergoing PRP for severe NPDR or PDR.
Study contact: Sunny Kallay – 603-436-1773
Status: Open Enrollment
Principal Investigator: Richard Chace
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