Clinical Research Directory

20-20-20 Rule Plus Artificial Tears for Dry Eye

This study is for anyone struggling with dry, tired, or uncomfortable eyes, especially from long hours on screens. Investigators all know that feeling after staring at a laptop or phone too long. This study from Zagazig University looks at a simple habit called the 20-20-20 rule: every 20 minutes, take a 20-second break to look at something about 20 feet away. Investigators want to see if doing this every day, along with participant's regular artificial tears, helps participants eyes feel better than tears alone. If participant join, participant will use artificial tears as usual. Some participants will also be asked to practice the 20-20-20 rule throughout the day. Investigators will follow participant for about 8 weeks and check participant symptoms, tear film, and overall eye comfort with simple eye exams and questionnaires. There is no experimental drug involved, just a daily habit Investigators hope will make standard treatment work better. The study was approved by the Institutional Review Board, Faculty of Medicine, Zagazig University on 07-September-2024.

a Novel siRNA Eyedrops for DED Treatment

A single-center, randomized, double-blind, placebo-controlled, cross-over clinical trial designed to evaluate the effectiveness and safety of a novel siRNA eye drops for the treatment of dry eye syndrome

Yogic Eye Exercises for Computer Vision Syndrome in Female Design Students

Computer vision syndrome (CVS) is a cluster of eye and musculoskeletal complaints - dryness, redness, blurred vision, foreign body sensation, excessive tearing, and neck, shoulder or back pain - that arises from prolonged work at a digital display. It is common among university students, and optical, pharmacological and nutritional treatments have given inconsistent results. Yoga-based eye exercises have been proposed as a brief, inexpensive alternative that requires no equipment. This study tested whether a short, structured programme of yogic eye exercises reduces self-reported CVS symptoms in female undergraduates in a graphic design and digital media programme, a group whose coursework demands sustained, colour-critical near work at a screen. All 36 female students enrolled in the programme took part. Each attended one supervised training session and then performed a 13-minute sequence of relaxation exercises (slow blinking, gazing at a distant target, acupressure around the eyes) and strengthening exercises (eye rolling, nose-tip gazing) three days a week for four weeks, a total of 12 sessions, reporting completion of each session on the same day. Nine symptoms - five ocular and four musculoskeletal - were rated on a four-point scale (never, rarely, sometimes, always) at the start and again at the end of week 4. The main question was whether the average of all nine ratings fell over the four weeks. Every participant served as her own comparison; there was no control group and no masking.

Evaluation of Tangible Boost for Patients With Stevens Johnson Syndrome, Sjogren's Syndrome, and Graft Vs Host Disease

The goal of this research is to determine if the Tangible Boost system adequately replenishes the Hydra-PEG coating on the surface of a rigid contact lens. Hydra-PEG is a coating for soft and rigid contact lens, primarily composed of polyethylene glycol-based hydrogel, which is covalently bound to the surface of a contact lens. The Hydra-PEG coating is intended to improve wettability and comfort with contact lenses and is currently FDA approved on a number of contact lenses. For patients with Stevens Johnson Syndrome (SJS) (SS), or Graft versus Host disease (GVHD), diminished efficacy of the Hydra-PEG coating can lead to significant decline in satisfaction with the lenses over time. This is a prospective study to evaluate the efficacy of Tangible Boost, a monthly conditioning solution, to replenish the Hydra-PEG coating on rigid gas permeable contact lenses for patients with SJS, GVHD, and SS. Outcomes from this patient population will be compared to patients with dry eye disease.

Evaporative Dry Eye

The goal of this clinical trial is to \[primary purpose is to learn if accordingly, the purpose of this study is to evaluate the effects of acoltremon in participants with evaporative DED, with a focus on characterizing how symptoms and evaporative DED signs change over the first month of treatment. \[primary hypothesis or outcome measure 1\] Change in unanesthetized Schirmer test score between pre-drop at baseline compared to post-drop score on Day 1 Researchers will compare all of the enrolled participants, and everyone will be provided the same treatment. Participants will • 2. Eye Dryness VAS: A 0-100 Eye Dryness VAS will be completed by the participants. * 3\. OSDI: The OSDI (0-100) will be completed by the subjects. * 4\. Visual Acuity: The participant's current corrected visual acuity will be measured with a high-contrast, Snellen chart. If the participant is unable to read the 20/40 letters (0.3 logMAR), the investigator will pinhole over the participant's unaided or presenting refractive error correction to determine the participant's visual potential. * 5\. Slit-Lamp Biomicroscopy: The investigator will use a slit-lamp biomicroscope to document normal and/or remarkable findings of the anterior eye structures: eyelashes, eyelids, conjunctiva, and cornea. * Schirmer's Test without Anesthesia (Pre-Drop): Schirmer's I test will be performed on each eye for 5 minutes. The amount of wetting will be measured on each strip. * Drop Application: 15 minutes after the pre-drop Schirmer's Test, one drop of acoltremon 0.003% will be applied to each eye. * Schirmer's Test without Anesthesia (Post-Drop): Schirmer's I test will be performed on each eye for 5 minutes 3 minutes post-drop application. The amount of wetting will be measured on each strip. * Tear Break Up Time (TBUT): TBUT will be determined by instilling sodium fluorescein using a strip wetted with saline (single drop and flicked to remove excess). Testing will start about 1 minute after fluorescein application. An average of three times will be utilized. A stopwatch will be used for timing. * Total Corneal Fluorescein Staining (NEI scale): Sodium fluorescein from TBUT testing will be used to evaluate corneal fluorescein staining. After waiting for about 2-minute, corneal staining will be assessed with a cobalt blue light and a yellow filter. Corneal staining will be graded with the original National Eye Institute (NEI) grading scale; 0-3 score/region (5 regions) with 0-15 score/eye. Meibomian Gland Secretion Score (0-15 scale): The 5 central glands on lower eyelid will be evaluated by the investigator with their finger (each scored 0-3): 0 = normal; 1 = thick/yellow; whitish, particulate; 2 = paste; 3 = none/occluded. The investigator will do their best to grade the same 5 glands each visit

Cooling Eyedrops for Dry Eye

In dry eye (DE), either insufficient aqueous tears are produced or the tears evaporate off the ocular surface too quickly. Meibomian gland dysfunction (MGD) results in poor quality or insufficient meibum being expressed during blinking, leading to a thinner tear lipid layer and faster aqueous tear evaporation. MGD is a major factor in evaporative dry eye globally. Activation of TRPM8 receptors on the cornea and eyelid margins gives a cooling sensation, which may increase the basal production of both aqueous tears and meibum through parasympathetic neural circuitry. The investigators hypothesize that acoltremon (TRYPTYR) 0.003% eye drops can increase tear lipid layer thickness and reduce the tear thinning rate.

Preliminary Clinical Study of the Effectiveness and Safety of Ocular Surface Microbiota Transplantation in the Treatment of Dry Eye Disease

Evaluate the efficacy and safety of ocular surface microbiota transplantation as an adjunctive therapy for dry eye, and explore its impact on the structure of the ocular surface microbiota.

Phase III Study of OT202 in Treating Moderate to Severe Dry Eye

This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial, enrolling 842 subjects with moderate to severe dry eye, who will be randomized at a 1:1 ratio to receive either 1% OT202 ophthalmic solution or vehicle control. The trial consists of screening, run-in, 8-week double-blind treatment period, and three long-term safety follow-up cohorts (10 weeks, 28 weeks, and 54 weeks), including 342 subjects for the 10-week follow-up, 350 subjects for the 28-week follow-up, and 150 subjects for the 54-week follow-up. Unblinding will be performed after the completion of double-blind treatment for all subjects, who will then receive open-label 1% OT202 ophthalmic solution uniformly. The co-primary efficacy endpoints are the change from baseline in Total Corneal Fluorescein Staining Score (TCSS) and Visual Analog Scale-Eye Dryness Score (VAS-EDS) at Day 56. Pharmacokinetic assessments will be conducted in 60 of the subjects assigned to the 54-weeks long-term safety follow-up. An interim futility analysis will be performed once approximately 30% of subjects complete the treatment period. Analysis of covariance (ANCOVA) will be utilized for efficacy statistical analyses. The primary objective is to evaluate the efficacy and safety of OT202 ophthalmic solution in the treatment of moderate to severe dry eye.

Contact Lens-Wearing Dry Eye Subjects Who Are Treated With Acoltremon 0.003%

Dry Eye Disease is a multifaceted condition which has symptoms such as eye dryness, burning, and stinging sensation in the eyes. As well as clinical diagnosis such as a decreased ability to create tear film. Despite improvements in Contact Lenses (CL) DED still is responsible for a large percentage of CL dropouts due to discomfort. Thus, the purpose of this study is to determine if acoltremon 0.003% can improve the frequency and severity of DED symptoms in CL wearers.

Evaluation of BTV100 in Subjects With Dry Eye Disease

This study will be a randomized, vehicle-controlled, double-masked, multiple-dose, parallel-group study to evaluate the efficacy, safety and tolerability of repeat dosing of Cevimeline Ophthalmic Solution compared to the vehicle in subjects with Dry Eye Disease (DED).

Effect of Acoltremon Ophthalmic Solution 0.003% on Tear Production and Symptoms in Patients With Tear Deficiency and Concurrent Neuropathic Corneal Pain

This study is designed to provide clinical data on how acoltremon ophthalmic solution 0.003% affects tear production and ocular symptoms in participants with tear deficiency and concurrent neuropathic corneal pain. Acoltremon is formulated to help increase natural tear production by activating TRPM8 (Transient Receptor Potential Melastatin 8) receptors on cold-sensitive corneal nerves. It is thought that this study treatment may help participants by increasing tear production while potentially reducing neuropathic ocular symptoms, including pain and discomfort. Participants will be followed for 8 weeks, evaluating the mean change in unanesthetized Schirmer test score between 3 minutes post-drop at Week 8 compared to pre-drop at baseline (Day 1), change in neuropathic symptom intensity as measured by a 0-10 VAS (Visual Analog Scale) from baseline to Week 8, and change in quality of life as assessed by the Ocular Pain Assessment Survey (OPAS) from baseline to Week 8. The study will also evaluate changes in corneal nerve structure, nerve function, corneal sensitivity, ocular surface symptoms, and treatment satisfaction.

Effect of a Dietary Supplement on Gut Microbiota and Ocular Surface Outcomes in Dry Eye Disease

This prospective clinical study investigates whether a dietary supplement product can modulate the gut microbiota and improve ocular surface outcomes in patients with dry eye disease. Participants will be recruited from Istanbul Medipol University Hospital (Department of Ophthalmology) and Liv Hospitals (Vadi Istanbul and Ulus). Each participant will receive the dietary supplement product for 8 weeks. Gut microbiota analyses will be conducted at baseline and week 8. Ocular surface assessments including Schirmer test and invasive tear breakup time (TBUT) will be performed at baseline and week 8.

Comparing Efficacy of Tea Tree Oil Versus Topical Azithromycin in Treating Dry Eye

This study aims to compare the effects of azithromycin and tea tree oil on the clinical outcomes and inflammatory profile of patients with MGD-associated DED. By focusing on changes in tear IL-8 and IL-17 levels, the study seeks to provide insights into the differential mechanisms of these two treatments and their potential in addressing inflammation-driven DED.

A Study to Evaluate the Performance and Safety of Artelac® Complete MDO® Versus VISMED® MULTI Eye Drops in the Management of Moderate to Severe Dry Eye Disease

A Double-Masked, Randomized, Parallel Group, Non-Inferiority Study to Evaluate the Performance and Safety of Artelac® Complete MDO® Versus VISMED® MULTI Eye Drops in the Management of Moderate to Severe Dry Eye Disease

Ocular Surface Disease in Glaucoma Patients on Long-Term Therapy

This cross-sectional study aims to determine the prevalence and severity of ocular surface disease among adult patients with glaucoma receiving long-term topical antiglaucoma medications.

Switching From Preserved Glaucoma Therapy to Preservative-Free ZOLYMBUS

Glaucoma is a large group of intraocular pressure-sensitive conditions that can cause progressive retinal ganglion cell (RGC) damage/loss and ultimately results in visual field loss that can produce irreversible blindness. The literature suggests that about 3.5% of the world's population has glaucoma and that is expected to grow as life expectancy increases and individuals continue to live longer lives. The first line of defense against progressive glaucoma includes eye drops that lower intraocular pressure. Which unfortunately comes with side effects that can damage the ocular surface of the eye. Nearly 60% of those who use these persevered eye drops experience symptoms commonly associated with dry eye disease (DED). Such as burning, stinging and itching. Thus the purpose of this study is to determine the effectiveness of switching from a preserved topical glaucoma drop to a preservative free topical glaucoma drop in glaucoma patients who also have symptomatic dry eye disease.

Evaluation of Lacrifill

Dry Eye Disease is defined as "a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface.' 'By the The Tear Film and Ocular Surface Society. Despite there being a number of factors that impact DED however one factor that has been considered likely is that of a complication from ocular surgery itself. Which can cause both corneal nerve, and ocular surface damage. Therefore this study aims to determine how Lacrfill performs in preventing post-operative dry eye symptoms in those who have recently had unilateral cataract surgery.

Dry Eye Screening and Referral System

Dry eye is one of the most common ocular surface diseases. Its pathogenic factors are related to multiple etiology. Because of the complexity of the pathogenesis of dry eye, the diversity of related examinations, and the inconsistency of symptoms and signs of dry eye patients, the diagnosis of dry eye has higher requirements on the professional technology and examination equipment of ophthalmologists. The purpose of this study is to establish a case-control cohort of dry eye patients. Multimodal data will be collected from participants, including medical history information, ocular surface disease index scale (OSDI), anterior segment photography, and treatment outcome of dry eye patients. The correlation between the characteristics of anterior segment images and dry eye diagnosis will be explored by artificial intelligence algorithms. The purpose of this study was to develop an artificial intelligence dry eye screening and referral system.

A Study of Full-Spectrum Screen Lighting for Reducing Screen-Related Eye Fatigue and Dry Eye

This study will evaluate whether full-spectrum screen bar lighting can reduce eye fatigue and dry eye symptoms after a standardized screen task. Prolonged screen use is common in daily work and study and may cause blurred vision, eye soreness, dryness, headache, and reduced attention. Light environment may be one way to improve visual comfort during screen use, but more controlled clinical evidence is needed. In this randomized, parallel-group controlled study, 112 healthy adult participants will be assigned to either a full-spectrum screen bar lighting group or a brightness-matched control group without screen bar lighting. Participants in both groups will complete an approximately 2-hour standardized screen task in a controlled laboratory environment. The study will compare changes before and after the task in objective and subjective measures of visual fatigue and dry eye, including critical flicker fusion frequency, visual fatigue questionnaire scores, eye movement and blinking parameters, pupil parameters, tear film-related measurements, and dry eye symptom scores. Safety and discomfort during the study will also be recorded.

Proteomics Analysis of Human Tears in the Diagnosis and Management of Dry Eye Disease

In this study, the initial tear proteome profiles in Dry Eye Disease (DED) patients, the safety and effectiveness of using an EC certificate DED treatment device in DED management, together with the associated global tear proteome changes, will be investigated.

Temporary Tear Duct Filling With Hyaluronic Acid Gel and Assessment of Dry Eye Disease (DED) After Bilateral Cataract Surgery

Dry eye disease can occur or worsen after cataract surgery and may cause ocular discomfort and reduced visual quality. Standard treatment commonly includes artificial tear eye drops, which provide temporary lubrication. Temporary occlusion of the tear drainage system may offer an alternative approach by increasing tear retention and improving tear film stability. This prospective, randomized, double-blind, inter-eye study will evaluate the use of LACRIFILL® Canalicular Gel, a crosslinked hyaluronic acid gel placed in the tear drainage system, in patients who have undergone bilateral cataract surgery. Treatment allocation will be randomized at the eye level within each participant. One eye will be assigned to treatment with LACRIFILL®, while the fellow eye will serve as the control and receive standard care with artificial tear eye drops. The study will compare the development and severity of dry eye disease between the randomized treatment and control eyes. The main outcome will be tear production measured by the Schirmer Test 1 one month after treatment. Additional assessments will include tear film stability, ocular surface findings, anterior segment imaging, visual quality, dry eye symptoms, use of artificial tears, and treatment-related safety outcomes during a three-month follow-up period.

Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3

The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.

BL-RX01-TFSTAB-1402

A study to investigate the ability of the iTrace™, BOSA™, OPD-Scan III, and IDRA to detect tear film stability utilizing Miebo®

Comparing Efficacy of Autologous Serum Eye Drops With and Without Insulin in Autoimmune Dry Eye.

Introduction: Dry Eye Disease (DED) of autoimmune origin is often severe and resistant to conventional treatments, necessitating alternative therapeutic options. Autologous Serum Eye Drops (ASED) have gained recognition for their biochemical and biomechanical properties, which closely mimic those of human tears. These properties make ASED an effective treatment for DED. Furthermore, topical insulin has demonstrated anti-inflammatory effects and promotes epithelial cell proliferation, differentiation, and migration, all of which contribute to maintaining ocular surface stability. As a result, insulin may serve as a valuable adjunct in treating moderate to severe autoimmune DED. Purpose: This study aims to assess and compare the effectiveness of autologous serum eye drops (group 1) and autologous serum eye drops combined with insulin (group 2) in improving the clinical signs and symptoms of moderate to severe DED in patients with autoimmune diseases, particularly those with Sjögren's Syndrome.