Evaluation of Rexon-Eye efficacy for dry eye subjects
- Conditions
- Dry eyeEye DiseasesOther disorders of lacrimal gland
- Registration Number
- ISRCTN12460884
- Lead Sponsor
- CooperVision Inc. (USA)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 54
Group 1: current daily disposable contact lens wearers
1. Age 18 to 45 years
2. Symptomatic wearers defined by a CLDEQ-8 score = 14
3. Presence of ocular tissue anomaly and/or low tear volume:
Group A: ocular tissue anomalies defined as bulbar conjunctival lissamine green staining Grade 2 or greater and/or
Group B: tear volume in the lower population quartile for contact lens wearers
4. Spectacle refraction: Sphere: -6.00D to + 4.00D, Astigmatism: 0.00D to -0.75D
5. Best corrected visual acuity of at least 20/30 in each eye
6. Have normal eyes with the exception of the need for visual correction
7. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule
Group 2: non-contact lens wearers dry eye sufferers
1. Age 18 to 65 years
2. Symptomatic dry eye sufferer defined by an OSDI score = 13
3. Presence of ocular tissue anomaly and/or low tear volume:
Group A: ocular tissue anomalies defined as bulbar conjunctival lissamine green staining Grade 2 or greater and/or
Group B: tear volume in the lower population quartile for non-contact lens wearers
4. Spectacle refraction: Sphere: -6.00D to + 4.00D, Astigmatism: 0.00D to -2.50D
5. Best corrected visual acuity of at least 20/30 in each eye
6. Have normal eyes with the exception of the need for visual correction
7. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule
1. Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear
2. Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator
3. Use of ocular medications
4 Monocular participants (only one eye with functional vision) or participants fit with only one contact lens
5. Any moderate or severe ocular condition observed during the slit-lamp examination at the enrolment visit
6. History of herpetic keratitis, ocular surgery or irregular cornea
7. Known pregnancy or lactation during the study period
8. Enrolment of the investigator or his/her staff, family members of the investigator, family members of the investigator’s staff, or individuals living in the households of these individuals
9. Participation in any clinical trial within 30 days of the enrolment visit
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Symptomatology for contact lens wearers is measured using the CLDEQ-8 score at all visits (baseline/enrollment, four weekly in-office treatment sessions and a follow up visit at 3 months)<br> 2. Symptomatology for non-contact lens wearers is measured using OSDI score at at all visits (baseline/enrollment, four weekly in-office treatment sessions and a follow up visit at 3 months)<br> 3. Ocular tissue is measured using bulbar conjunctival staining in mm2 at baseline, 1 month and 3 months<br> 4. Tear volume is measured using tearscope by evaluation of tear prism surface area at eye opening and at blink in mm at baseline, 1 month and 3 months<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Tear film non-invasive break-up time in seconds is measured using tearscope at baseline, 1 month and 3 months<br> 2. Contact lens or ocular surface exposed area at the time of the blink (as applicable) is measured using tearscope at baseline, 1 month and 3 months<br> 3. Contact lens or ocular surface tear film protective index (as applicable), measured using tearscope at baseline, 1 month and 3 months<br>