To study the impact of oral administration of lactoferrin in post refractive surgery dry eye.
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- ICMR
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- Prevalence of post refractive surgery dry eye
Study Overview
Brief Summary
This study aims to evaluate the dry eye induced by refractive surgery and the effect of oral lactoferrin on the post refractive surgery dry eye. Refractive surgeries are known to induce postoperative dry eye, furthermore, the inflammation caused by the surgery, the distortion of the ocular surface and preservative in the eye drops used post-operatively, all exacerbate the condition. Lactoferrin, a glycoprotein present in the tears, has several functions, including anti-inflammatory, antimicrobial and as well as promotion of cell growth. Lactoferrin treatment for the post refractive surgery dry eye proves to be significant by this study and we will be able to develop a feasible and reliable nutritional supplement for dry eye.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients undergoing refractive surgery.
- •2.Willingness to sign written informed consent and follow up.
Exclusion Criteria
- •1.Patients with a history of ocular surgery other than refractive surgery.
- •2.Pregnancy and feeding mothers.
- •3.Lactose intolerance or cow milk allergy.
- •4.Patients not willing for participate and follow ups.
Outcomes
Primary Outcomes
Prevalence of post refractive surgery dry eye
Time Frame: Prevalence of post refractive surgery dry eye | comes to 10% from 35% at 6 month post surgery
comes to 10% from 35% at 6 month post surgery
Time Frame: Prevalence of post refractive surgery dry eye | comes to 10% from 35% at 6 month post surgery
Secondary Outcomes
- Bioavailability of lactoferrin in tear film(Tear samples will be collected at baseline,)
Investigators
Dr Namrata Sharma
AIIMS