Eye Drops for Dry Eye Syndrome
(PreDICT Trial)
Recruiting in Palo Alto (17 mi)
SC
Overseen byStephanie Cox, OD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Tufts Medical Center
Must not be taking: Topical treatments
Disqualifiers: Centralized pain, Ocular surgery, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This is a single site, prospective, cross-sectional, controlled clinical study on a total of 66 subjects. The subjects are divided into two groups: Hypertonic Saline Non-Responders (33 subjects) and Hypertonic Saline Responders (33 subjects). After completion of questionnaires, the subjects will undergo Dry Eye Disease testing and functional nerve testing. Subjects who qualify will be dispensed 4 weeks of preservative free artificial tears and instructed to instill one drop into each eye twice daily. Subjects will return for a follow up visit 4 weeks later (± 4 days), during which subjects will complete the questionnaires again and the Dry Eye Disease tests and functional nerve tests will be repeated.
Will I have to stop taking my current medications?
The trial requires that you have not changed your medications in the last 3 months and do not anticipate any changes during the study. If you are using other topical treatments, you may need to stop them.
What data supports the effectiveness of the treatment Preservative-free Refresh Optive Advanced Lubricant Eye Drops for Dry Eye Syndrome?
Is Preservative-free Refresh Optive Advanced Lubricant Eye Drops safe for use?
How is Preservative-free Refresh Optive Advanced Lubricant Eye Drops different from other treatments for dry eye syndrome?
Research Team
SC
Stephanie Cox, OD
Principal Investigator
Tufts Medical Center New England Eye Center
Eligibility Criteria
Adults with Dry Eye Disease (DED) who have specific symptoms and test results, like a SANDE score of 50mm or more, low tear production, short tear break-up time, or poor meibomian gland function. Not for those using other eye treatments, with recent eye surgery/injury/allergies, contact lens use in the last month, medication changes recently or during the study.Inclusion Criteria
I did not respond to hypertonic saline treatment.
My level of discomfort or pain has not changed.
I have less pain or discomfort now.
See 14 more
Exclusion Criteria
You are allergic to a preservative called benzalkonium chloride (BAK) used in eye drops.
I haven't changed my medications in the last 3 months and don't plan to change them during the treatment.
I am using other skin treatments.
See 6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive preservative-free artificial tears for 4 weeks, instilling one drop into each eye twice daily
4 weeks
1 visit (in-person)
Follow-up
Participants return for a follow-up visit where questionnaires and tests are repeated
4 weeks
1 visit (in-person)
Treatment Details
Interventions
- Preservative-free Refresh Optive Advanced Lubricant Eye Drops (Artificial Tears)
Trial OverviewThe trial is testing preservative-free Refresh Optive Advanced Lubricant Eye Drops on two groups: one that responds to hypertonic saline and one that doesn't. Participants will use the drops twice daily for four weeks and undergo questionnaires and eye tests before and after treatment.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Hypertonic Saline RespondersExperimental Treatment1 Intervention
Subjects who qualify as hypertonic saline responders will be instructed to instill 1-2 drops of preservative-free Refresh Optive Advanced Lubricant Eye Drops, which are available over the counter, into each eye twice a day for 28 days.
Group II: Hypertonic Saline Non-respondersExperimental Treatment1 Intervention
Subjects who qualify as hypertonic saline non-responders will be dispensed the same instructions and treatment as the Hypertonic Saline Responders. They will be instructed to instill 1-2 drops of preservative-free Refresh Optive Advanced Lubricant Eye Drops, which are available over the counter, into each eye twice a day for 28 days.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Tufts Medical Center-New England Eye CenterBoston, MA
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Who Is Running the Clinical Trial?
Tufts Medical Center
Lead Sponsor
Trials
264
Patients Recruited
264,000+
References
Can the optimum artificial tear treatment for dry eye disease be predicted from presenting signs and symptoms? [2019]To assess dry eye treatment with four preservative-free dry eye artificial tear treatments to facilitate evidence-based prescribing.
A Comparison of Efficacy and Safety of Two Lipid-Based Lubricant Eye Drops for the Management of Evaporative Dry Eye Disease. [2022]The aim of this study was to compare the efficacy of two lipid-based lubricant eye drops in patients with lipid-deficient dry eye.
Prophylactic action of lipid and non-lipid tear supplements in adverse environmental conditions: A randomised crossover trial. [2021]To evaluate the prophylactic benefits of lipid-based and non-lipid-based artificial tear lubricants, in dry eye disease, after adverse environmental exposure.
An investigation of the efficacy of a novel ocular lubricant. [2015]To investigate the efficacy of a novel ocular lubricant compared with a commercially marketed ocular lubricant in a group of noncontact lens wearers currently using over-the-counter products for the management of symptoms of moderate to severe dry eye.
Effects of osmoprotective eye drops on tear osmolarity in contact lens wearers. [2016]To evaluate the impact of osmoprotective eye drops on tear osmolarity and patient comfort, and to compare its efficacy with a commercially available lubricant in contact lens (CL) wearers.
Safety and comfort evaluation of a new formulation of Visine(®) lubricant eye drops containing HydroBlend™ and GentlePur™. [2020]To evaluate the clinical safety and comfort of a new benzalkonium chloride-free Visine(®) lubricant eye drop formulation (Hydroblend™ and GentlePur™) in healthy and dry eye subjects.
A two-week clinical evaluation of the safety of Systane Ultra in contact lens-wearing patients. [2022]To evaluate the safety of Systane((R)) Ultra Lubricant Eye Drops (test solution) in contact lens wearers. A currently marketed contact lens rewetting drop was the control solution.
Clinical evaluation of an oil-based lubricant eyedrop in dry eye patients with lipid deficiency. [2022]To evaluate and compare the efficacy of a lipid-based lubricant eyedrop formulation (hydroxypropyl guar/propylene glycol/phospholipid [HPG/PG/PL]) with preservative-free saline for the treatment of dry eye.
Comparison of the effects of various lubricant eye drops on the in vitro rabbit corneal healing and toxicity. [2017]Ingredients of lubricant eye drops are potentially harmful to the ocular surface. The products Optive, Optive Fusion, Neopt were tested regarding corneal irritability versus Vismed Multi and 0.01% benzalkonium chloride as negative and positive control, respectively. Formulas (30-40μl per hour) were applied hourly in-vitro for six days on rabbit corneas (n=5, per product) cultured in artificial anterior chambers (EVEIT system). Initially, four corneal abrasions (2.4-4.6mm2) were induced. All defects were monitored during drop application by fluorescein stains and photographs. To ensure corneal vitality, glucose and lactate concentrations in artificial anterior chamber fluids were determined photometrically. All products showed a complete corneal healing on day 2. Thereafter, all five Optive-treated corneas developed progressive fluorescein-positive epithelial lesions until day six (24.96μm, ±21.45μm, p<0.01). For Optive Fusion three corneas showed corneal erosions on day six (23.11μm, ±37.02μm, p>0.5) while Vismed Multi did not adversely affect the corneal integrity. Glucose/lactate concentrations remained unchanged while lubricants were applied. Histology revealed epithelial loss and severe alterations of the superficial stroma for Optive. Optive Fusion displayed a comparable pathology. Neopt did not significantly affect the corneal healing and integrity. This study suggested a cumulative corneal toxicity of Optive and, to a lesser extent, Optive Fusion most likely caused by its oxidative preservative, SOC. Clinical data are needed to clarify the application frequency at which corneal toxicity might occur. Neopt and Vismed Multi did not affect the corneal integrity.
Slow-release artificial tear inserts in the treatment of dry eyes resulting from the oculomucocutaneous syndrome. [2019]Patients with dry eyes resulting from the practolol syndrome present a therapeutic challenge. Very frequent instillation of preservative-free drops are the only therapy in most cases. Using an entirely new agent--a hydrophilic polymer in insert form--we have provided in this open study an alternative therapy which shows some subjective and objective advantages. Few patients experienced problems, and none left the study because of failure of retention of the insert. Some patients preferred the cooling, soothing effects of frequent drops. The problems in mounting a clinical trial of this sort are discussed.
One month use of Systane improves ocular surface parameters in subjects with moderate symptoms of ocular dryness. [2021]To evaluate the efficacy of Systane((R)) Lubricating Eye Drops in improving the symptoms of moderate ocular dryness.
Tear osmolarity measurement using the TearLab Osmolarity System in the assessment of dry eye treatment effectiveness. [2022]To evaluate the efficacy of three commercially available lubricant eye drops for the treatment of mild, dry, irritated eyes.