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Dry Eye clinical trials

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NCT ID: NCT05573360 Completed - Dry Eye Clinical Trials

Evaluation of Safety and Tolerability of Ocular Lubricants

Start date: December 16, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety profile of test formulations for an artificial tear product versus a comparator product.

NCT ID: NCT05528016 Completed - Dry Eye Clinical Trials

Short and Long-term Results of Skin Versus Skin Plus Orbicularis Resection Blepharoplasty

Start date: May 1, 2021
Phase: N/A
Study type: Interventional

This study aims to evaluate the short and long-term effects of skin-only and skin+muscle excision blepharoplasty on corneal nerves, dry eye parameters, meibomian glands, and eyebrow position.

NCT ID: NCT05523531 Completed - Dry Eye Clinical Trials

Prospective Single-center Long-term Follow-up Study of a Series of Cases Previously Included in the QUALVIDON Study

QUALVIDON2
Start date: September 15, 2022
Phase:
Study type: Observational

Dry eye affects millions of people around the world. Some dry eye patients complain of neuropathic eye pain that can affect their quality of life. From August 2016 to June 2017, the QUALVIDON study (NCT03296111), conducted at the Adolphe de Rothschild Foundation Hospital, assessed pain and its impact on quality of life using self-administered questionnaires in a series of dry eye patients. This 2nd study, entitled QUALVIDON2, focuses on the outcome of patients previously included in QUALVIDON.

NCT ID: NCT05505292 Completed - Dry Eye Clinical Trials

Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers

Start date: September 22, 2022
Phase: Phase 4
Study type: Interventional

This is a prospective, single site, randomized, double masked, comparator-controlled study designed to evaluate the efficacy of lifitegrast ophthalmic solution 5% in treating the symptoms of dry eye in soft contact lens wearers as compared to control. We hypothesize that there will be a significant improvement in dry eye symptoms in contact lens wearers using lifitegrast as compared to those being treated with control (lifitegrast vehicle).

NCT ID: NCT05481450 Completed - Dry Eye Clinical Trials

Efficacy and Safety Safety of Nutritears® in Adults With Dry Eye Syndrome

Start date: August 15, 2022
Phase: N/A
Study type: Interventional

This is a prospective, randomized, double-blind, parallel, placebo-controlled, clinical interventional study. The purpose of this study is to evaluate the efficacy and safety of Nutritears®, a dietary supplement of OmniActive Health Technologies, in adult subjects with dry eye syndrome (DES). Subjects shall be instructed to consume one capsule of their assigned investigational study product every morning after the breakfast, at the same time every day, for 56 days (8 weeks).

NCT ID: NCT05322148 Completed - Dry Eye Clinical Trials

Cyclosporine 0.1% / Loteprednol 0.2% Effect on Anterior Segment Normalization

CLEAN
Start date: June 3, 2022
Phase: Phase 3
Study type: Interventional

The CLEAN Study: Cyclosporine 0.1% / Loteprednol 0.2% Effect on Anterior Segment Normalization-A Prospective Cohort Study of Combination Therapy in the Treatment of Dry Eye

NCT ID: NCT05299619 Completed - Dry Eye Clinical Trials

Tixel Treatment for Dry Eye Symptoms

Start date: March 28, 2019
Phase: N/A
Study type: Interventional

Dry eye syndrome is caused by a chronic lack of sufficient lubrication and moisture on the surface of the eye. Consequences of dry eyes range from subtle but constant eye irritation to significant inflammation and even scarring of the front surface of the eye. Meibomian Gland Dysfunction (MGD) refers to the condition where the glands are not secreting enough oil or when the oil they secrete is of poor quality. Tixel is a fractional skin rejuvenation system, which relies on direct thermal energy delivery, free of any radiation type such as laser, RF, etc. The energy is transferred via a continuously sterile, thermal titanium element (the "Tip"), located on the applicator (the "Handpiece"). In this study, the principal investigator will undertake standard treatment of periorbital wrinkles with Tixel and observe the effect on dry eye disease symptoms and signs.

NCT ID: NCT05288582 Completed - Dry Eye Clinical Trials

Tear Lipid Layer Thickness Assessments With Perfluorohexyloctane Eye Drops

Start date: March 27, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to explore the tear lipid layer quantitatively and qualitatively before and after use of a perflurohexyloctane eye drop (NovaTears)

NCT ID: NCT05247333 Completed - Constipation Clinical Trials

Implementation of a Minor Ailment Service in Community Pharmacy Practice

INDICA+PRO
Start date: October 1, 2020
Phase: N/A
Study type: Interventional

Self-care and self-medication are commonly the treatments of choice for the management of minor ailments. Minor ailments can be treated through community pharmacy using a Minor Ailment Service (MAS). The INDICA+PRO Impact Study, evaluated the clinical, economic and humanistic impact of a MAS, concluding that community pharmacies could greatly benefit the health system. Thus, the following objectives were defined for the INDICA+PRO implementation study. The primary objective is to implement a standardised MAS in usual practice in community pharmacy in Spain. The secondary objectives include an evaluation of the clinical and economic outcomes and the role and impact of two different models of change agents. A pragmatic study with an effectiveness-implementation hybrid design type 3 will be undertaken using the Framework for the Implementation of Services in Pharmacy (FISpH). The study will be carried between October 2020 and December 2022. Two type of practice change facilitators FaFa and SEFaFa. Their main function, using the Observe-Plan-Do-Study-Act process, will be to facilitate the implementation through individualised continuous support to providers of the MAS. The depth and breadth of support to pharmacist providers by each type of change agents will vary. Pharmaceutical Associations (PA) and/or Spanish Society of Community Pharmacy (SEFAC) will invite community pharmacies/pharmacists. Participating pharmacists will need to sign a commitment form. The second study population will consist of patients presenting with minor ailments or requesting a non-prescription medication. Recruitment of patients will be carried out by the pharmacist providers. The inclusion criteria will be: patients or caregivers (aged ≥18 years, or younger if they are accompanied by an adult) presenting with 31 minor ailments, grouped into five categories (respiratory, moderate pain, digestive, dermatological and other) with pre-agreed referral protocols. Other symptoms may be included at the discretion of the pharmacists. The exclusion criteria will be patients who do not provide informed consent. The patient/pharmacist intervention will consist of a MAS protocol adapted for each symptom. The consultation will be record in an electronic data capture system (SEFAC eXPERT®-) that provides a step-by-step approach with protocols and clinical information embedded. The FISpH model will be used to guide the implementation of MAS. Two types of change agents, FaFas and SeFaFas, previously trained for 18 hours, will be used to facilitate the implementation. During each of the stages (exploration, preparation, testing and operation, and initial sustainability), strategies will be used by FaFas and SeFaFas to moderate implementation factors. The impact of strategies will be evaluated. Data on pharmacy/pharmacist's provider performance and patient outcomes will be provided to pharmacist, change agents and PA and SEFAC. FaFas and SeFaFas will have a classification system for barriers and facilitators derived from the constructs in the Consolidated Framework for Implementation Research (CFIR). The classification system for implementation strategies consists of an adaptation of the facilitation activities listed by Dogherty et al. These will be documented in an electronic data capture system. FaFas will train their pharmacists (max. of 25 pharmacies) for 6 hours and subsequently provide at least monthly follow-up. The research team will provide ongoing feedback and support to the FaFas and SeFaFas through periodically, hold group meetings by video conference between the research group and all the FaFas and SeFaFas. The research group will provide formal reports on the implementation process and patient outcomes. Other forms of communication such as emails, telephone calls or WhatsApp messaging will also be available. Implementation and patient consultation process and outcome variables will be measured such as reach, fidelity and integration. Outcome service indicators will be clinical, economic and humanistic. A patient follow up will occur at a maximum of 10 days. Continuous variables will be reported using mean and standard deviation, or median and percentiles. Categorical variables will be reported using percentages. T Student's test or the ANOVA test or Kruskal-Wallis. χ2 test, Fisher's exact test or Yate's chi-squared will also be used. To determine the relationship between the dependent and the independent variables, logistic regression models will be performed including the variables with statistical significance in the bivariate model. The level of significance will be set at p <0.05. Machine learning and big data techniques are being considered for predictive modelling. The research team will only have access to de-identified data of pharmacists and patients. This study protocol has been approved by the Granada Research Ethics Committee on the 5th February 2020.

NCT ID: NCT05239494 Completed - Dry Eye Clinical Trials

Dailies Total 1 Sphere Contact Lenses

Start date: May 23, 2022
Phase: N/A
Study type: Interventional

CL discomfort is a complex phenomenon that has been defined by the Tear Film and Ocular Surface Society in their seminal report on contact lens (CL) discomfort as a condition that results in "episodic or persistent adverse ocular sensation related to lens wear, either with or without visual disturbance resulting from reduced compatibility between the CL and the environment, which can lead to decreased wearing time and discontinuation of CL wear." A recent review by Pucker and Tichenor found that CL discomfort was the top reason for established CL wears to cease wearing CLs. This same review alarmingly found that the frequency of CL dropout was about 20% across the many studies aimed at evaluating this condition, which is surprising given the introduction of better soft CL materials and daily disposable CLs over the past 20 plus years. Dailies Total1 (DT1), which is a relatively new daily disposable CL, is a commonly used trouble shooting CL for patients who have failed with other CLs because DT1 utilizes advanced material technology that is specifically aimed at improving CL comfort. While DT1 is commonly used in these struggling patients, the literature currently lacks a targeted study aimed at understanding the frequency of successfully refitting CL dropouts into this advanced CL. Thus, the purpose of this study is to determine the frequency that past CL wearers who failed because of dryness or CL discomfort who can comfortable wear DT1.