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Efficacy, Tolerability, and Comfort of 0.3% Hypromellose Eyedrops in Patients Undergoing LASIK Surgery

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00909324
First received: May 26, 2009
Last updated: February 24, 2011
Last verified: February 2011
History of Changes
  Purpose

This study is designed to assess the tolerability and comfort of peri-operative 0.3% hypromellose eye drops in LASIK surgery patients and to assess whether pre-operative 0.3% hypromellose eye drops add to post-operative comfort in LASIK surgery patients compared to control (no pre-operative lubricant).


Condition Intervention Phase
Dry Eye Syndromes
 Drug: Pre-LASIK 0.3% hypromellose
Drug: Post-LASIK 0.3% hypromellose
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy, Tolerability and Comfort of 0.3% Hypromellose Eyedrops in the Pre- and Post-Operative Treatment of Patients Undergoing LASIK Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in Ocular Comfort Level From Baseline to End of Study [ Time Frame: Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery ] [ Designated as safety issue: No ]
    Patients rated their ocular comfort on a scale of 0 to 10 on the following parameters: Burning sensation, foreign body sensation, itching, watering of eyes, dryness of eyes, and photophobia. A higher score indicated greater discomfort. A negative change score indicated improvement.


Secondary Outcome Measures:
  • Change in Tear Breakup Time From Baseline to End of Study [ Time Frame: Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery ] [ Designated as safety issue: No ]
    The time required for dry spots to appear on the corneal surface after blinking. Sodium fluorescein dye is added to the eye and the tear film is observed under a slit lamp while the patient avoids blinking until tiny dry spots develop. The longer it takes, the more stable the tear film. A short tear breakup time is a sign of a poor tear film. Generally, >10 seconds is thought to be normal, 5 to 10 seconds marginal, and <5 seconds low (with high likelihood of dry eye symptoms), ie, a shorter time indicates greater eye dryness. A positive change score indicates improvement.

  • Change in the Results of Schirmer's Test From Baseline to End of Study [ Time Frame: Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery ] [ Designated as safety issue: No ]
    Schirmer's test determines tear production, and whether the eye produces enough tears to keep it moist. A small strip of filter paper is inserted inside the lower eyelid of each eye and the eyes are closed for 5 minutes. The paper is then removed and the length of paper that is moist is measured. A young person normally moistens 15 mm of the paper. The shorter the length of moist paper, the dryer the eyes. A positive change score indicates improvement.


Enrollment: 162
Study Start Date: August 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pre-LASIK 0.3% hypromellose Drug: Pre-LASIK 0.3% hypromellose
Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
Active Comparator: Post-LASIK 0.3% hypromellose Drug: Post-LASIK 0.3% hypromellose
Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.

  Eligibility

Ages Eligible for Study:   21 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 21 - 35
  • Both sexes
  • Seeking LASIK surgery at the Refractive Surgery Centre
  • Meeting all established criteria for appropriateness for LASIK established by the treating center

Exclusion Criteria:

  • Any corneal pathology including scars, prior herpes keratitis, prior corneal transplant
  • Any immuno-compromised state including cancer, HIV infection, Hepatitis B or C, or diabetes mellitus
  • Requirement for any eye-drops for any reason (eg, dry eye or conjunctivitis) within 3 months from time of enrollment
  • Anticipated refusal or inability to undergo planned post-operative visits or assessment
  • Failure to meet all established criteria for appropriateness for LASIK
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00909324

Locations
India
Novartis Investigational Site
Delhi, India, 110088
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis India Ltd. Novartis India Ltd.
  More Information

No publications provided

Responsible Party: Medical Affairs, Novartis India Ltd
ClinicalTrials.gov Identifier: NCT00909324     History of Changes
Other Study ID Numbers: CGET980AIN03
Study First Received: May 26, 2009
Results First Received: January 12, 2011
Last Updated: February 24, 2011
Health Authority: India: Drugs Controller General of India

Keywords provided by Novartis:
Post LASIK dry eye
Pre LASIK dry eye
Hypromellose

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Tetrahydrozoline
 Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013