Comparison of Ocular Lubricants in People With Symptoms of Dry Eye (SPHINX)

University of Waterloo

Status and phase: Enrolling; Phase 4

Conditions: Dry Eye Symptoms

Treatments: Device: 3% trehalose and 0.15% sodium hyaluronate; Drug: Propylene glycol 0.6%

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07451184

47903

98631981 (Other Grant/Funding Number)

Details and patient eligibility

About

Ocular dryness and discomfort are symptoms commonly associated with dry eye. Lubricating eye drops, also called artificial tears, are often used to moisten the eye and provide relief from these symptoms. There are currently several types of lubricating eye drops available, differing in their ingredients, consistency, and recommended frequency of application. The aim of this study is to compare the effectiveness of two lubricating eye drops that differ in their ingredients and recommended frequency of application. The goal is to see whether they perform the same or if one of them provides better relief for people with dry eye symptoms. One of the eye drops is commercially available in Canada, the other one is not commercially available in Canada and therefore considered an investigational eye drop. This eye drop is available in the United States of America. In this study, participants will use one drop twice per day and the other drop four times per day. Each product will be used for 4 weeks and all participants will use both products (one after the other). There will be a 2-week period of no drops between the two study products. Before starting each drop and after 4 weeks of drop use, we will assess the eyes of the participants and ask them how their eyes feel. Participants will also be asked to answer a series of questions regarding the drops. Participants will encounter procedures that they normally experience in an eye care setting. The results will help the funding company to better understand the performance of the products used in this study. It may also help eyecare practitioners in managing their patients with dry eye symptoms. The hypothesis is that the drop used twice a day will be non-inferior to the drop used 4 times per day for the change in dry eye symptoms (assessed with the Ocular Surface Disease Index questionnaire) after 4 weeks of use.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Are at least 18 years of age and have full legal capacity to volunteer;

2. Have understood and signed an institutional review board (IRB)/ independent ethics committee (IEC) approved informed consent form;

3. Are willing and able to attend all study visits as required per protocol;

4. Are willing to discontinue use of all habitual artificial tear supplements and use only the study drops as directed for the entire study duration;

5. Have dry eye symptomatology as per TFOS DEWS II definition:

   • Have an OSDI score ≥13;

6. Have an absence of active* anterior segment disease;

7. Have not worn contact lenses for the previous 14 days before screening, and are willing to not wear contact lenses for the duration of the study;

8. Are correctable to a visual acuity of +0.20 LogMAR or better (in at least one eye) with refraction results.

Exclusion criteria

1. Have taken part in an interventional clinical study within the previous 14 days before screening;
2. Are participating in any concurrent ocular or interventional clinical trial;
3. Have any active* ocular inflammation, infection, or are using ocular topical treatment (other than dry eye drops);
4. Started any systemic medication known to cause dry eye (e.g., anti-histamine, antidepressants, benzodiazepines, etc.) within 30 days before screening. Stable dosing for >30 days before screening is allowed, but changes (including commencing new) of dosing of such medication within the study period would lead to early exit from the study;
5. Had any ocular injury or surgery within the 1 year prior to screening, nor have ocular surgery planned/ anticipated;
6. Have biomicroscopy signs of grade 3 or more (Efron scale);
7. Have known sensitivity to the diagnostic pharmaceuticals or to any ingredients in the study products;
8. Are pregnant, lactating or planning a pregnancy at the time of enrolment;
9. Are a member of the Centre for Ocular Research & Education directly involved in this study (on the delegation log);
10. Are an employee of Alcon.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Systane Pro PF/ Thealoz Duo

Experimental group

Description:

Use of Systane Pro PF for 4 weeks, followed by use of Thealoz Duo for 4 weeks

Treatment:

Drug: Propylene glycol 0.6%

Device: 3% trehalose and 0.15% sodium hyaluronate

Thealoz Duo / Systane Pro PF

Experimental group

Description:

Use of Thealoz Duo for 4 weeks, followed by use of Systane Pro PF for 4 weeks

Treatment:

Drug: Propylene glycol 0.6%

Device: 3% trehalose and 0.15% sodium hyaluronate